Cumulative List of Designated Approved Orphan Products
	Total Number of Active Designations  	325	Effective:	5/16/2008
	Generic Name	Approved Orphan Indication:
	acetylcysteine	For the use of Acetadote(registered TM) Injection, administered 
	intravenously within 8 to 10 hours after ingestion of a potentially heptotoxic
	 quantity of acetaminophen, to prevent or lessen hepatic injur
	Trade Name:
	Acetadote	Orphan Designation:
	For the intravenous treatment of moderate to severe acetaminophen 
	overdose
	Designation 
	10/19/2001	Sponsor and Address
	Marketing Exclusivity 	Cumberland Pharmaceuticals, Inc.
	1/23/2004	209 10th Street South
	Suite 332
	Nashville TN  37203 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Adalimumab	Treatment of Juvenile Idiopathic Arthritis
	Trade Name:
	Humira	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	3/21/2005	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	2/21/2008	200 Abbott Park Road
	Abbott Park IL  60064-6157
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Albendazole	Treatment of parenchymal neurocysticercosis due to active lesions caused 
	by larval forms of the pork tapeworm, Taenia solium.
	Trade Name:
	Albenza	Orphan Designation:
	Treatment of neurocysticercosis due to Taenia solium as: 1) chemotherapy 
	of parenchymal, subarachnoidal and racemose (cysts in spinal fluid) 
	Designation 	neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and 
	1/18/1996	other sequelae in asymptomatic neurocysticercosis.
	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	6/11/1996	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Albendazole	Treatment of cystic hydatid disease of the liver, lung, and peritoneum, 
	caused by the larval form of the dog tapeworm, Echinococcus granulosus.
	Trade Name:
	Albenza	Orphan Designation:
	Treatment of hydatid disease (cystic echinococcosis due to E. granulosus 
	larvae or alveolar echinococcosis due to E. multilocularis larvae).
	Designation 
	1/17/1996	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	6/11/1996	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aldesleukin	Treatment of adults (>18 years old) with metastatic renal cell carcinoma.
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of metastatic renal cell carcinoma.
	Designation 
	9/14/1988	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	5/5/1992	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aldesleukin	Treatment of adults with metastatic melanoma.
	Trade Name:
	Proleukin	Orphan Designation:
	Treatment of metastatic melanoma.
	Designation 
	9/10/1996	Sponsor and Address
	Marketing Exclusivity 	Chiron Corporation
	1/9/1998	4560 Horton Street
	Emeryville CA  94608-2916
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	alemtuzumab	The treatment of patients with B-cell chronic lymphocytic leukemia who 
	have been treated with alkylating agents and who have failed fludarabine 
	therapy.
	Trade Name:
	Campath	Orphan Designation:
	Treatment of chronic lymphocytic leukemia.
	Designation 
	10/20/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	5/7/2001	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alglucerase injection	Long-term enzyme replacement therapy for children, adolescents and adult
	 patients with a confirmed diagnosis of Type I Gaucher disease who
	exhibit signs and symptoms that are severe enough to result in one or more 
	Trade Name:	of the following conditions:
	a) moderate-to-severe anemia;
	b) thrombocytopenia with bleeding tendency;
	c) bone disease;
	d) significant hepatomegaly or splenomegaly.
	Ceredase	Orphan Designation:
	For replacement therapy in patients with Gaucher's disease type I.
	Designation 
	3/11/1985	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/5/1991	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Alitretinoin	Topical treatment of cutaneous lesions in patients with AIDS-related 
	Kaposi's sarcoma.
	Trade Name:
	Panretin	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	3/24/1998	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc
	2/2/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Allopurinol sodium	Management of patients with leukemia, lymphoma, and solid tumor 
	malignancies who are receiving cancer therapy which causes elevations of 
	serum and urinary uric acid levels and who cannot tolerate oral therapy.
	Trade Name:
	Aloprim for Injection	Orphan Designation:
	Management of patients with leukemia, lymphoma, and solid tumor 
	malignancies who are receiving cancer therapy which causes elevations of 
	Designation 	serum and urinary uric acid levels and who cannot tolerate oral therapy.
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Catalytica Pharmaceuticals, Inc
	5/17/1996	PO Box 1887
	Greenville NC  27835-1887
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Alpha1-proteinase inhibitor (human)	For chronic replacement therapy of individuals having congenital 
	deficiency of alpha1- proteinase inhibitor with clinically demonstrable 
	panacinar emphysema.
	Trade Name:
	Prolastin	Orphan Designation:
	For replacement therapy in the alpha-1-proteinase inhibitor congenital 
	deficiency state.
	Designation 
	12/7/1984	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/2/1987	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Altretamine	Single agent palliative treatment of patients with persistent or recurrent 
	ovarian cancer following first-line therapy with a cisplatin and/or alkylating 
	agent based combination.
	Trade Name:
	Hexalen	Orphan Designation:
	Treatment of advanced adenocarcinoma of the ovary.
	Designation 
	2/9/1984	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/26/1990	One Tower Bridge
	100 Front Street, Suite 400
	Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ambrisentan	Treatment of pulmonary arterial hypertension (WHO group I) in patients 
	with WHO class II or III symptoms to improve exercise capacity and delay 
	clinical worsening
	Trade Name:
	Letairis	Orphan Designation:
	Treatment of pulmonary arterial hypertension 
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Gilead Colorado
	6/15/2007	7575 West 103rd Avenue
	Suite 102
	Westminister CO  80021-5426
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine	To reduce the cumulative renal toxicity associated with repeated 
	administration of cisplatin in patients with advanced ovarian cancer.
	Trade Name:
	Ethyol	Orphan Designation:
	For use as a chemoprotective agent for cisplatin in the treatment of 
	advanced ovarian carcinoma.
	Designation 
	5/30/1990	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/8/1995	One Tower Bridge
	100 Front Street, Suite 400
	West Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amifostine	Reduction of the incidence of moderate to severe xerostomia in patients 
	undergoing post-operative radiation treatment for head and neck cancer, 
	where the radiation port includes a substantial portion of the parotid glands. 
	Trade Name:
	Ethyol	Orphan Designation:
	Reduction of the incidence of moderate to severe xerostomia in patients 
	undergoing post-operative radiation treatment for head and neck cancer.
	Designation 
	5/12/1998	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	6/24/1999	One Tower Bridge
	100 Front Street, Suite 400
	Conshohocken PA  19428 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Aminosalicylic acid	Treatment of tuberculosis
	Trade Name:
	Paser Granules	Orphan Designation:
	Treatment of tuberculosis infections
	Designation 
	2/19/1992	Sponsor and Address
	Marketing Exclusivity 	Jacobus Pharmaceutical Company
	6/30/1994	37 Cleveland Lane
	P.O. Box 5290
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amiodarone HCl	For initiation of treatment and prophylaxis of frequently recurring ventricular
	 fibrillation and hemodynamically unstable ventricular tachycardia in 
	patients refractory to other therapy.
	Trade Name:
	Cordarone	Orphan Designation:
	For the acute treatment and prophylaxis of life-threatening ventricular 
	tachycardia or ventricular fibrillation.
	Designation 
	3/16/1994	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Ayerst Laboratories
	8/3/1995	P.O. Box 8299
	Philadelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Amphotericin B lipid complex	Treatment of invasive fungal infections in patients who are refractory to or 
	intolerant of conventional amphotericin B therapy.
	Trade Name:
	Abelcet	Orphan Designation:
	Treatment of invasive fungal infections.
	Designation 
	12/5/1991	Sponsor and Address
	Marketing Exclusivity 	Liposome Company, Inc.
	10/18/1996	One Research Way
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Anagrelide	Treatment of patients with essential thrombocythemia to reduce the 
	elevated platelet count and the risk of thrombosis and to ameliorate 
	associated symptoms.
	Trade Name:
	Agrylin	Orphan Designation:
	Treatment of essential thrombocythemia.
	Designation 
	1/27/1988	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	3/14/1997	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (human)	For surgical and/or invasive procedures in patients with von Willebrand 
	Disease (VWD) in whom desmopressin is either ineffective or 
	contraindicated.  It is not indicated for patients with severe VWD (Type 3) 
	Trade Name:	undergoing major surgery
	Alphanate	Orphan Designation:
	Treatment of von Willebrand's disease
	Designation 
	1/5/1996	Sponsor and Address
	Marketing Exclusivity 	Grifols Biologicals Inc.
	1/31/2007	5555 Valley Boulevard
	Los Angeles CA  90032-3548
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (recombinant)
	Trade Name:
	ReFacto	Orphan Designation:
	For the control and prevention of hemorrhagic episodes and for surgical 
	prophylaxis in patients with hemophilia A (congenital factor VIII deficiency 
	Designation 	or classic hemophilia).
	2/8/1996	Sponsor and Address
	Marketing Exclusivity 	Wyeth Pharmaceuticals, Inc.
	1/1/9999	P. O. Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor (recombinant)	Treatment and prophylaxis of bleeding in patients with hemophilia A (not 
	von Willebrand's disease)
	Trade Name:
	Kogenate	Orphan Designation:
	Prophylaxis and treatment of bleeding in individuals with hemophilia A or 
	for prophylaxis when surgery is required in individuals with hemophilia A.
	Designation 
	9/25/1989	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	2/25/1993	1884 Miles Avenue
	Elkhart IN  46515 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antihemophilic factor/von Willebrand factor complex 	(1) In adult patients for treatment and prevention of bleeding in hemophilia
	(human), dried, pasteurized	 A (classic hemophilia) and (2) in adult and pediatric patients for treatment 
	of spontaneous and trauma-induced bleeding episodes in severe von 
	Trade Name:	Willebrand disease, and in mild and moderate von Willebrand disease 
	where use of desmopressin is known or suspected to be inadequate.
	Humate-P	Orphan Designation:
	Treatment of patients with von Willebrand's disease 
	Designation 
	10/16/1992	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring L.L.C.
	4/1/1999	1020 First Avenue
	PO Box 61501
	King Of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III (human)
	Trade Name:
	ATnativ	Orphan Designation:
	For the treatment of patients with hereditary antithrombin III deficiency in 
	connection with surgical or obstetrical procedures or when they suffer from 
	Designation 	thromboembolism.
	2/8/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn AB
	12/13/1989	Lindhagensgatan 133
	SE-112 87 
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Antithrombin III (human)
	Trade Name:
	Thrombate III	Orphan Designation:
	For replacement therapy in congenital deficiency of AT-III for prevention 
	and treatment of thrombosis and pulmonary emboli.
	Designation 
	11/26/1984	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/30/1991	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Antivenin, crotalidae polyvalent immune Fab (ovine)	Carol Clark-Evans direct line (615) 963-4510
	Trade Name:
	CroFab	Orphan Designation:
	Treatment of envenomations inflicted by North American crotalid snakes.
	Designation 
	1/12/1994	Sponsor and Address
	Marketing Exclusivity 	Protherics, Inc.
	10/2/2000	1207 17th Ave. S., Suite 103
	Nashville TN  37212 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Apomorphine HCl	For the acute, intermittent treatment of hypomobility, "off" episodes ("end-
	of-dose-wearing-off" and unpredictable :on/off" episodes) associated with 
	advanced Parkinson's disease
	Trade Name:
	Apokyn	Orphan Designation:
	Treatment of the on-off fluctuations associated with late-stage Parkinson's 
	disease.
	Designation 
	4/22/1993	Sponsor and Address
	Marketing Exclusivity 	Vernalis R & D Ltd
	4/20/2004	Oakdene Court
	Winnersh, Berkshire RG41 5UA
	    
	UNITED KINGDOM
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Aprotinin
	Trade Name:
	Trasylol	Orphan Designation:
	For prophylactic use to reduce perioperative blood loss and the 
	homologous blood transfusion requirement in patients undergoing 
	Designation 	cardiopulmonary bypass surgery in the course of repeat coronary artery 
	11/17/1993	bypass graft surgery, and in selected cases of primary coronary artery bypass
	 graft surgery where the risk of bleeding is especially high (impaired 
	hemostasis) or where transfusion is unavailable or unacceptable.
	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/29/1993	Pharmaceutical Division
	400 Morgan Lane
	West Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Arsenic trioxide	For induction of remission and consolidation in patients with acute 
	promyelocytic leukemia (APL) who are refractory to, or have relapsed from, 
	retinoid and anthracycline chemotherapy, and whose APL is characterized 
	Trade Name:	by the presence of the t(15;17) translocation of PML/RAR-alpha gene 
	Trisenox	Orphan Designation:
	Treatment of acute promyelocytic leukemia.
	Designation 
	3/3/1998	Sponsor and Address
	Marketing Exclusivity 	Cell Therapeutics, Inc.
	9/25/2000	201 Elliott Ave. West
	Suite 400
	Seattle WA  98119 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Atovaquone	Prevention of PCP in patients who are intolerant to trimethoprim-
	sulfamethoxazole.
	Trade Name:
	Mepron	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-
	infected patients defined by a history of one or more episodes of PCP 
	Designation 	and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or
	8/14/1991	Sponsor and Address	 equal to 200/mm3.
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	1/5/1999	5 Moore Drive
	PO Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Atovaquone	For the acute oral treatment of mild to moderate Pneumocystis carinii 
	pneumonia in patients who are intolerant to trimethoprim-sulfamethoxazole.
	Trade Name:
	Mepron	Orphan Designation:
	Treatment of AIDS associated Pneumocystis Carinii Pneumonia.
	Designation 
	9/10/1990	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	11/25/1992	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	azacitidine	Treatment of patients with the following myelodysplastic syndrome 
	subtypes:  refractory anemia or refractory anemia with ringed sideroblasts (if 
	accompanied by neutropenia or thrombocytopenia and requiring 
	Trade Name:	transfusions), refractory anemia with excess blasts, refractory anemia with 
	excess blasts in transformation, and chronic myelomonocytic leukemia
	Vidaza	Orphan Designation:
	Treatament of myelodysplastic syndromes
	Designation 
	12/3/2001	Sponsor and Address
	Marketing Exclusivity 	Pharmion Corporation
	5/19/2004	2525 28th Street
	Boulder CO  80301 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Baclofen	Management of severe spasticity of spinal cord origin in patients who are 
	unresponsive to oral baclofen therapy or experience intolerable CNS side 
	effects at effective doses.
	Trade Name:
	Lioresal Intrathecal	Orphan Designation:
	Treatment of intractable spasticity caused by spinal cord injury, multiple 
	sclerosis, and other spinal diseases (including spinal ischemia, spinal tumor,
	Designation 	 transverse myelitis, cervical spondylosis, and degenerative myelopathy).
	11/10/1987	Sponsor and Address
	Marketing Exclusivity 	Medtronic, Inc.
	6/25/1992	800 53rd Avenue N.E.
	Minneapolis MN  55432 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Balsalazide disodium	Treatment of mildly to moderately active ulcerative colitis in patients 5 
	years of age and older.  Safety and Effectiveness of Colazal beyond 8 
	weeks in children (ages 5-17) and 12 weeks in adults have not been 
	Trade Name:	established.
	Colazal	Orphan Designation:
	Treatment of pediatric patients with ulcerative colitis
	Designation 
	8/12/2005	Sponsor and Address
	Marketing Exclusivity 	Salix Pharmaceuticals, Inc.
	12/20/2006	1700 Perimeter Park Drive
	Morrisville NC  27560 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Basiliximab	Prophylaxis of acute organ rejection in patients receiving renal 
	transplantation when used as part of an immunosuppressive regimen that 
	includes cyclosporine and corticosteroids.
	Trade Name:
	Simulect	Orphan Designation:
	Prophylaxis of solid organ rejection.
	Designation 
	12/12/1997	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	5/12/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bendamustine hydrochloride	Treatment of patients with chronic lymphocytic leukemia
	Trade Name:
	Treanda	Orphan Designation:
	Treatment of chronic lymphocytic leukemia
	Designation 
	8/17/2007	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	3/20/2008	41 Moores Road
	Frazer PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Benzoate and phenylacetate
	Trade Name:
	Ucephan	Orphan Designation:
	For adjunctive therapy in the prevention and treatment of 
	hyperammonemia in patients with urea cycle enzymopathy due to 
	Designation 	carbamylphosphate synthetase, ornithine, transcarbamylase, or 
	1/21/1986	Sponsor and Address	argininosuccinate synthetase deficiency.
	Marketing Exclusivity 	Immunex
	12/23/1987		2525 McGaw Avenue
	12/23/1987	Immunex
	P.O. Box 19791
	Irvine CA  92623 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	benzoate/phenylacetate	Adjunctive therapy in the treatment of acute hyperammonemia and 
	associated encephalopathy in patients with deficiencies in enzymes of the 
	urea cycle.
	Trade Name:	
	Ammonul	Orphan Designation:
	Treatment of acute hyperammonemia and associated  encephalopathy in 
	patients with deficiencies in enzymes of the urea cycle.
	Designation 
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Medicis Pharmaceutical Corp.
	2/17/2005	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beractant	Prevention of RDS (hyaline membrane disease) in premature infants less 
	than 1250 grams birthweight or with evidence of surfactant deficiency.
	Trade Name:
	Survanta intratracheal suspension	Orphan Designation:
	Prevention of neonatal respiratory distress syndrome.
	Designation 
	2/5/1986	Sponsor and Address
	Marketing Exclusivity 	Ross Laboratories
	7/1/1991	625 Cleveland Avenue
	Columbus OH  43215 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Beractant	Treatment of ("rescue") of premature infants with RDS confirmed by x-ray 
	and requiring mechanical ventilation.
	Trade Name:
	Survanta intratracheal suspension	Orphan Designation:
	Treatment of neonatal respiratory distress syndrome.
	Designation 
	2/5/1986	Sponsor and Address
	Marketing Exclusivity 	Ross Laboratories
	7/1/1991	625 Cleveland Avenue
	Columbus OH  43215 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Betaine	Treatment of homocystinuria to decrease elevated homocysteine blood 
	levels.
	Trade Name:
	Cystadane	Orphan Designation:
	Treatment of homocystinuria.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	10/25/1996	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bexarotene	Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in 
	patients who are refractory to at least one prior systemic therapy.  
	Trade Name:
	Targretin	Orphan Designation:
	Treatment of cutaneous T-cell lymphoma.  
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc.
	12/29/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	biocarbonate infusate	Use as a replacement solution in Continuous Renal Replacement Therapy 
	(CRRT) to replace water and to correct electrolytes and acid-base 
	imbalances in adults and children
	Trade Name:
	Normocarb HF	Orphan Designation:
	Use in the management of patients undergoing continuous renal 
	replacement therapy with hemofiltration
	Designation 
	8/9/2005	Sponsor and Address
	Marketing Exclusivity 	Dialysis Solutions, Inc.
	7/26/2006	14 Emmett Place
	Whitby, Ontario L1R 2B4
	    
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bleomycin sulfate	Treatment of malignant pleural effusion.
	Trade Name:
	Blenoxane	Orphan Designation:
	Treatment of malignant pleural effusion.
	Designation 
	9/17/1993	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	2/20/1996	P.O. Box 4000
	Princeton NJ  08543 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Bortezomib	Treatment of multiple myeloma patients who have received at least  one 
	prior therapy
	Trade Name:
	Velcade	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/15/2003	Sponsor and Address
	Marketing Exclusivity 	Millennium Pharmaceuticals, Inc.
	3/25/2005	40 Landsdowne Street
	Canbridge  MA  02139 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Bosentan	Treatment of pulmonary arterial hypertension.
	Trade Name:
	Tracleer	Orphan Designation:
	Treatment of pulmonary arterial hypertension.
	Designation 
	10/6/2000	Sponsor and Address
	Marketing Exclusivity 	Actelion Life Sciences Ltd.
	11/20/2001	1840 Gateway Dr.
	2nd Floor
	San Mateo CA  94404 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A	Treatment of cervical dystonia in adults to decrease the severity of 
	abnormal head position and neck pain associated with cervical dystonia.
	Trade Name:
	Botox	Orphan Designation:
	Treatment of cervical dystonia.
	Designation 
	8/20/1986	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/21/2000	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92623-9534
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Botox	Orphan Designation:
	Treatment of strabismus associated with dystonia in adults (patients 12 
	years of age and above).
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/29/1989	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type A
	Trade Name:
	Botox	Orphan Designation:
	Treatment of blepharospasm associated with dystonia in adults (patients 12 
	years of age and above).
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	12/29/1989	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Botulinum toxin type B	Treatment of patients  with cervical dystonia to reduce the severity of 
	abnormal head position and neck pain associated with cervical dystonia.
	Trade Name:
	Myobloc	Orphan Designation:
	Treatment of cervical dystonia.
	Designation 
	1/16/1992	Sponsor and Address
	Marketing Exclusivity 	Elan Pharmaceuticals, Inc.
	12/8/2000	800 Gateway Blvd.
	South San Francisco CA  94080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Botulism immune globulin	Indicated for treatment of infant botulism caused by type A or type B 
	Clostridium botulinum. 
	Trade Name:
	BabyBIG 	Orphan Designation:
	Treatment of infant botulism.
	Designation 
	1/31/1989	Sponsor and Address
	Marketing Exclusivity 	California Department of Health Services
	10/23/2003	2151 Berkeley Way
	Berkeley CA  94704-1011
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buffered intrathecal electrolyte/dextrose injection	For the intrathecal administration of methotrexate and cytarabine for the 
	prevention or treatment of meningeal leukemia and lymphocytic lymphoma.
	Trade Name:
	Elliotts B Solution	Orphan Designation:
	For use as a diluent in the intrathecal administration of methotrexate and 
	cytarabine for the prevention or treatment meningeal leukemia and 
	Designation 	lymphocytic lymphoma.
	8/24/1994	Sponsor and Address
	Marketing Exclusivity 	QOL Medical, LLC
	9/27/1996	12419  198th Drive, NE
	Woodinville WA  98072 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buprenorphine hydrochloride	Treatment of opioid dependence in patients 16 years of age or older
	Trade Name:
	Subutex	Orphan Designation:
	Treatment of opiate addiction in opiate users.
	Designation 
	6/15/1994	Sponsor and Address
	Marketing Exclusivity 	Reckitt Benckiser  Pharmaceuticals, Inc.
	10/8/2002	1901 Huguenot Road
	Richmond VA  23235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Buprenorphine in combination with naloxone	Treatment of opioid dependence in patients 16 years of age or older
	Trade Name:
	Suboxone	Orphan Designation:
	Treatment of opiate addiction in opiate users.
	Designation 
	10/27/1994	Sponsor and Address
	Marketing Exclusivity 	Reckitt Benckiser Pharmaceuticals, Inc.
	10/8/2002	1901 Huguenot Road
	Richmond VA  23235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Busulfan	For use in combination with cyclophosphamide as a conditioning regimen 
	prior to allogeneic hematopoietic progenitor cell transplantation for chronic
	 myelogenous leukemia.  
	Trade Name:
	Busulfex	Orphan Designation:
	As preparative therapy in the treatment of malignancies with bone marrow 
	transplantation.
	Designation 
	7/28/1994	Sponsor and Address
	Marketing Exclusivity 	Otsuka Pharmaceutical Company
	2/4/1999
	Tokyo
	    
	JAPAN
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Caffeine	Short term treatment of apnea of prematurity in infants between 28 and less
	 than 33 weeks gestational age.  
	Trade Name:
	Cafcit	Orphan Designation:
	Treatment of apnea of prematurity.
	Designation 
	9/20/1988	Sponsor and Address
	Marketing Exclusivity 	O.P.R. Development, L.P.
	9/21/1999	1501 Wakarusa Drive
	Lawrence KS  66047 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcitonin-human for injection
	Trade Name:
	Cibacalcin	Orphan Designation:
	Treatment of symptomatic Paget's disease (osteitis deformans).
	Designation 
	1/20/1987	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	10/31/1986	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Calcium acetate
	Trade Name:
	Phos-Lo	Orphan Designation:
	Treatment of hyperphosphatemia in end stage renal failure.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Braintree Laboratories
	12/10/1990	60 Columbian Street
	P.O. Box 361
	Braintree MA  02184 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ceramide trihexosidase/alpha-galactosidase A	For use in patients with Fabry disease to reduce globotriaosylceramide (GL-
	3) deposition in capillary endothelium of the kidney and certain other cell 
	types
	Trade Name:
	Fabrazyme	Orphan Designation:
	Treatment of Fabry's disease.
	Designation 
	1/19/1988	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/24/2003	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cetuximab	For use in combination with radiation therapy, for the treatment of locally or
	 regionally advanced squamous cell carcinoma of the head and neck 
	(SCCHN) and for use as a single agent for the treatment of patients with 
	Trade Name:	recurrent or metastatic SCCHN for whom prior platinum-based therapy has 
	Erbitux	Orphan Designation:
	Treatment of squamous cell cancer of the head and neck in patients who 
	express epidermal growth factor receptor.  
	Designation 
	7/3/2000	Sponsor and Address
	Marketing Exclusivity 	ImClone Systems Incorporated
	3/1/2006	33 ImClone Drive
	Branchburg NJ  08876 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Chenodiol
	Trade Name:
	Chenix	Orphan Designation:
	For patients with radiolucent stones in well opacifying gallbladders, in 
	whom elective surgery would be undertaken except for the presence of 
	Designation 	increased surgical risk due to systemic disease or age.
	9/21/1984	Sponsor and Address
	Marketing Exclusivity 	Solvay
	7/28/1983	901 Sawyer Road
	Marietta GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	cinacalcet	Treatment of hypercalcemia in patients with parathyroid carcinoma
	Trade Name:
	Sensipar	Orphan Designation:
	Treatment of hypercalcemia in patients with parathyroid carcinoma
	Designation 
	5/12/2003	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	3/8/2004
	One Amgen Center Drive
	Thousand Oaks CA  91320-1799
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Citric acid, glucono-delta-lactone and magnesium 
	carbonate
	Trade Name:
	Renacidin Irrigation	Orphan Designation:
	Treatment of renal and bladder calculi of the apatite or struvite variety.
	Designation 
	8/28/1989	Sponsor and Address
	Marketing Exclusivity 	United-Guardian, Inc.
	10/2/1990	P.O. Box 2500
	Smithtown NY  11787 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cladribine
	Trade Name:
	Leustatin Injection	Orphan Designation:
	Treatment of hairy cell leukemia.
	Designation 
	11/15/1990	Sponsor and Address
	Marketing Exclusivity 	R. W. Johnson Pharmaceutical Research Institute
	2/26/1993	Route 202, P.O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	clofarabine	Treatment of pediatric patients 1 to 21 years old with relapsed or refractory 
	acute lymphoblastic leukemia after at least two prior regimens
	Trade Name:
	Clolar	Orphan Designation:
	Treatment of acute lymphoblastic leukemia
	Designation 
	2/7/2002	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	12/28/2004	4545 Horizon Hill Blvd.
	San Antonio TX  78229-2263
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Clofazimine
	Trade Name:
	Lamprene	Orphan Designation:
	Treatment of lepromatous leprosy, including dapsone-resistant lepromatous
	 leprosy and lepromatous leprosy complicated by erythema nodosum 
	Designation 	leprosum.
	6/11/1984	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	12/15/1986	59 Route 10
	East Hanover NJ  07936 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Clonidine	In combination with opiates for the treatment of severe pain in cancer 
	patients that is not adequately relieved by opioid analgesics alone.
	Trade Name:
	Duraclon	Orphan Designation:
	For continous epidural administration as adjunctive therapy with intraspinal 
	opiates for the treatment of pain in cancer patients tolerant to, or 
	Designation 	unresponsive to, intraspinal opiates.
	1/24/1989	Sponsor and Address
	Marketing Exclusivity 	Roxane Laboratories, Inc.
	10/2/1996	PO Box 16532
	Columbus OH  43216-6532
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor IX	Prevention and control of bleeding in factor IX deficiency, also known as 
	hemophilia B or Christmas disease.
	Trade Name:
	Mononine	Orphan Designation:
	Replacement treatment and prophylaxis of the hemorrhagic complications 
	of hemophilia B.
	Designation 
	6/27/1989	Sponsor and Address
	Marketing Exclusivity 	Armour Pharmaceutical Company
	8/20/1992	500 Arcola Road, P.O. Box 1200
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor IX (human)
	Trade Name:
	AlphaNine	Orphan Designation:
	For use as replacement therapy in patients with hemophilia B for the 
	prevention and control of bleeding episodes, and during surgery to correct 
	Designation 	defective hemostasis.
	7/5/1990	Sponsor and Address
	Marketing Exclusivity 	Alpha Therapeutic Corporation
	12/31/1990	5555 Valley Boulevard
	Los Angeles CA  90032 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor IX (recombinant)	For the control and prevention of hemorrhagic episodes in patients with 
	hemophilia B (congenital factor IX deficiency and Christmas disease), 
	including control and prevention of bleeding in surgical settings.
	Trade Name:
	BeneFix	Orphan Designation:
	Treatment of hemophilia B.
	Designation 
	10/3/1994	Sponsor and Address
	Marketing Exclusivity 	Genetics Institute, Inc.
	2/11/1997	87 Cambridge Park Drive
	Cambridge MA  02140 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	patients with acquired hemophilia
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with acquired inhibitors to 
	Factor VIII or Factor IX 
	Designation 
	7/21/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	10/13/2006	100 College Road West
	Princeton  NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	patients with congenital F VII deficiency
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with congenital Factor VII 
	deficiency
	Designation 
	9/10/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	7/11/2005	100 College Road West
	Princeton  NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation Factor VIIa (Recombinant)	Treatment of bleeding episodes in surgical interventions or invasive 
	procedures in patients with acquired hemophilia
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in patients with acquired inhibitors to 
	Factor VIII or Factor IX
	Designation 
	7/16/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	10/13/2006	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Prevention of bleeding in surgical interventions or invasive procedures in 
	hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
	Trade Name:
	NovoSeven	Orphan Designation:
	Prevention of bleeding episodes in patients with hemophilia A or B, with or 
	without inhibitors
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	8/12/2005	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Treatment of bleeding episodes in patients with Factor VII Deficiency
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in patients with congenital factor VII 
	deficiency
	Designation 
	9/10/2004	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	7/11/2005	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Coagulation factor VIIa (recombinant)	Treatment of bleeding episodes in hemophilia A or B patients with 
	inhibitors to Factor VIII or Factor IX.  
	Trade Name:
	NovoSeven	Orphan Designation:
	Treatment of bleeding episodes in hemophilia A or B patients with 
	inhibitors to Factor VIII or Factor IX.
	Designation 
	6/6/1988	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk, Inc.
	3/25/1999	100 Overlook Center
	Suite 200
	Princeton NJ  08540-7810
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colfosceril palmitate, cetyl alcohol, tyloxapol
	Trade Name:
	Exosurf Neonatal for Intratracheal Suspension	Orphan Designation:
	Treatment of established hyaline membrane disease at all gestational ages.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	8/2/1990	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Colfosceril palmitate, cetyl alcohol, tyloxapol
	Trade Name:
	Exosurf Neonatal for Intratracheal Suspension	Orphan Designation:
	Prevention of hyaline membrane disease, also known as respiratory distress 
	syndrome, in infants born at 32 weeks gestation or less.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	8/2/1990	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Corticorelin ovine triflutate	To differentiate between pituitary and ectopic production of ACTH in 
	patients with ACTH-dependent Cushing's syndrome.
	Trade Name:
	Acthrel	Orphan Designation:
	For use in differentiating pituitary and ectopic production of ACTH in 
	patients with ACTH-dependent Cushings syndrome.
	Designation 
	11/24/1989	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	5/23/1996	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cromolyn sodium
	Trade Name:
	Gastrocrom	Orphan Designation:
	Treatment of mastocytosis.
	Designation 
	3/8/1984	Sponsor and Address
	Marketing Exclusivity 	Fisons Corporation
	12/22/1989	755 Jefferson Rd
	P.O. Box 1710
	Rochester NY  14603 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Cromolyn sodium 4% ophthalmic solution
	Trade Name:
	Opticrom 4% ophthalmic solution	Orphan Designation:
	Treatment of vernal keratoconjunctivitis.
	Designation 
	7/24/1985	Sponsor and Address
	Marketing Exclusivity 	Fisons Corporation
	10/3/1984	755 Jefferson Rd.
	P.O. Box 1710
	Rochester NY  14603 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cysteamine	Treatment of nephropathic cystinosis in adults and children.
	Trade Name:
	Cystagon	Orphan Designation:
	Treatment of nephropathic cystinosis.
	Designation 
	1/25/1991	Sponsor and Address
	Marketing Exclusivity 	Mylan Laboratories, Inc.
	8/15/1994	781 Chestnut Ridge Road
	P.O. Box 4310
	Morgantown WV  26504 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytarabine liposomal	Intrathecal treatment of lymphomatous meningitis.
	Trade Name:
	DepoCyt	Orphan Designation:
	Treatment of neoplastic meningitis.
	Designation 
	6/2/1993	Sponsor and Address
	Marketing Exclusivity 	Pacira Pharmaceuticals, Inc.
	4/1/1999	10450 Science Center Drive
	San Diego CA  92121 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Cytomegalovirus immune globulin (human)	#1) Attenuation of primary CMV disease associated with kidney transplant 
	recipients who are seronegative for CMV and who receive a kidney from a 
	CMV seropositve donor; #2)  Prophylaxis of CMV disease associated 
	Trade Name:	transplantation of kidney (all other), lung, liver, pancreas and heart.    
	CytoGam	Orphan Designation:
	Prevention or attenuation of primary cytomegalovirus disease in 
	immunosuppressed recipients of organ transplants.
	Designation 
	8/3/1987	Sponsor and Address
	Marketing Exclusivity 	Massachussetts Public Health Biologic Laboratories
	12/4/1998	305 South Street
	Boston MA  02130-3597
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Daclizumab	Prophylaxis of acute organ rejection in patients receiving renal transplants, 
	to be used as a part of an immunosuppressive  regimen that includes 
	cyclosporine and corticosteroids.
	Trade Name:
	Zenapax	Orphan Designation:
	Prevention of acute renal allograft rejection.
	Designation 
	3/5/1993	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	12/10/1997	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dasatinib	Treatment of adults with Philadelphia chromosome-positive acute 
	lymphoblastic leukemia with resistance or intolerance to prior therapy
	Trade Name:
	Sprycel	Orphan Designation:
	Treatment of Philadelphia-positive acute lymphoblastic leukemia
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	6/28/2006	5 Research Parkway
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dasatinib	Treatment of adults with chronic myeloid leukemia with resistance or 
	intolerance to prior therapy including imatinib
	Trade Name:
	Sprycel	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	11/28/2005	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Company
	6/28/2006	5 Research Parkway
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Daunorubicin citrate liposome injection	First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma. 
	Trade Name:
	DaunoXome	Orphan Designation:
	Treatment of patients with advanced HIV-associated Kaposi's sarcoma.
	Designation 
	5/14/1993	Sponsor and Address
	Marketing Exclusivity 	NeXstar Pharmaceuticals, Inc.
	4/8/1996	650 Cliffside Drive
	San Dimas CA  91773 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Decitabine	for treatment of patients with myelodysplastic syndromes (MDS) including 
	previously treated and untreated, de novo and secondary MDS of all 
	French-American-British subtypes (refractory anemia, refractory anemia with
	Trade Name:	 ringed sideroblasts, refractory anemia with excess blasts, refractory anemia 
	with excess blasts in transformation, and chronic myelomonocytic leukemia)
	 and intermediate-1, intermediate-2, and high-risk International Prognostic 
	Dacogen	Orphan Designation:
	Treatment of myelodysplastic syndromes.  
	Designation 
	3/8/1999	Sponsor and Address
	Marketing Exclusivity 	MGI CP, Inc. d/b/a MGI Pharma
	5/2/2006	6611 Tributary Street
	Suite 200
	Baltimore MD  21224 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Deferasirox	Treatment of chronic iron overload due to blood transfusions (transfusional 
	hemosiderosis) in patients 2 years of age or older
	Trade Name:
	Exjade	Orphan Designation:
	Treatment of chronic iron overload in patients with transfusion-dependent 
	anemias
	Designation 
	11/21/2002	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/2/2005	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell 
	lymphoma whose malignant cells express the CD25 component of the IL-2 
	receptor.
	Trade Name:
	Ontak	Orphan Designation:
	Treatment of patients with Cutaneous T-cell Lymphoma.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Eisai Medical Research, Inc.
	2/5/1999	55 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Desmopressin acetate	Treatment of patients with hemophilia A or von Willebrand's disease (type I)
	 whose factor VIII coagulant activity level is greater than 5%.
	Trade Name:
	Orphan Designation:
	Treatment of mild hemophilia A and von Willebrand's disease.
	Designation 
	1/22/1991	Sponsor and Address
	Marketing Exclusivity 	Aventis Behring L.L.C.
	3/7/1994	1020 First Avenue
	PO Box 61501
	King of Prussia PA  19406-0901
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	dexrazoxane	Treatment of extravasation resulting from IV anthracycline chemotherapy
	Trade Name:
	Totect	Orphan Designation:
	Treatment of anthracycline extravasation during chemotherapy
	Designation 
	3/25/2004	Sponsor and Address
	Marketing Exclusivity 	Topo Target A/S
	9/6/2007	Fruebjergvej 3, 2100 
	Copenhagen    
	 
	DENMARK
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dexrazoxane	Cardiomyopathy associated with doxorubicin administration in women with 
	metastatic breast cancer who have received a cumulative dose of 
	300mg/m2.
	Trade Name:
	Zinecard	Orphan Designation:
	For the prevention of cardiomyopathy associated with doxorubicin 
	administration.
	Designation 
	12/17/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	5/26/1995	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Diazepam viscous solution for rectal administration
	Trade Name:
	Orphan Designation:
	For the management of selected, refractory, patients with epilepsy, on 
	stable regimens of antiepileptic drugs (AEDs), who require intermittent use 
	Designation 	of diazepam to control bouts of increased seizure activity.
	2/25/1992	Sponsor and Address
	Marketing Exclusivity 	Valeant Pharmaceuticals
	7/29/1997	3300 Hyland Avenue
	Costa Mesa CA  92626 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Diethylenetriaminepentaacetic acid (DTPA)	Treatment of internal contamination with plutonium, americium or curium
	Trade Name:
	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	plutonium, americium, or curium to increase the rates of elimination.
	Designation 
	4/28/2004	Sponsor and Address
	Marketing Exclusivity 	Hameln Pharmaceuticals gmbh
	8/11/2004	Langes Feld 13
	Hameln    
	 
	GERMANY
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Digoxin immune FAB (Ovine)
	Trade Name:
	Digibind	Orphan Designation:
	Treatment of potentially life threatening digitalis intoxication in patients 
	who are refractory to management by conventional therapy.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	4/22/1986	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Dornase alfa	In conjunction with standard therapies in the management of cystic fibrosis 
	patients to reduce the frequency of respiratory infections requiring 
	parenteral antibiotics and to improve pulmonary function.
	Trade Name:
	Pulmozyme	Orphan Designation:
	To reduce mucous viscosity and enable the clearance of airway secretions 
	in patients with cystic fibrosis.
	Designation 
	1/16/1991	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/30/1993	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Doxorubicin HCL liposome injection	For use in combination with bortezomib for the treatment of patients with 
	multiple myeloma who have not previously received bortezomib and have 
	at least one prior
	Trade Name:	therapy.
	Doxil	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	12/29/2004	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical Research & Dev.
	5/17/2007	920 US Highway 202, P. O. Box 300
	Raritan NJ  08869 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Doxorubicin liposome	Treatment of metastatic carcinoma of the ovary in patients with disease that
	 is refractory to both paclitaxel- and platinium-based chemotherapy 
	regimens.  Refractory disease is defined as disease that has progressed 
	Trade Name:	while on treatment, or within 6 months of completing treatment.  
	Doxil	Orphan Designation:
	Treatment of ovarian cancer.
	Designation 
	11/4/1998	Sponsor and Address
	Marketing Exclusivity 	Alza Corporation
	6/28/1999	1550 Plymouth St.
	PO Box 7210
	Mountain View CA  94039-7210
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Dronabinol	Treatment of anorexia associated with weight loss in patients with AIDS.
	Trade Name:
	Marinol	Orphan Designation:
	For the stimulation of appetite and prevention of weight loss in patients 
	with a confirmed diagnosis of AIDS.
	Designation 
	1/15/1991	Sponsor and Address
	Marketing Exclusivity 	Unimed Pharmaceuticals, Inc.
	12/22/1992	901 Sawyer Rd.
	Marietta  GA  30062 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	eculizumab	Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
	Trade Name:
	Soliris	Orphan Designation:
	Treatment of paroxysmal nocturnal hemoglobinuria
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Alexion Pharmaceuticals, Inc.
	3/16/2007	352 Knotter Drive
	Cheshire CT  06410 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Eflornithine HCl
	Trade Name:
	Ornidyl	Orphan Designation:
	Treatment of Trypanosoma brucei gambiense infection (sleeping sickness).
	Designation 
	4/23/1986	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	11/28/1990	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epirubicin	Component of adjuvant therapy in patients with evidence of axillary node 
	tumor involvement following resection of primary breast cancer.
	Trade Name:
	Ellence	Orphan Designation:
	Treatment of breast cancer.
	Designation 
	9/14/1999	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn Company
	9/15/1999	0634-298-113
	7000 Portage Rd.
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoetin alfa	Treatment of AZT-induced anemia in HIV infected patients.
	Trade Name:
	Epogen	Orphan Designation:
	Treatment of anemia associated with HIV infection or HIV treatment.
	Designation 
	7/1/1991	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/31/1990	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Epoetin alfa
	Trade Name:
	Epogen	Orphan Designation:
	Treatment of anemia associated with end stage renal disease.
	Designation 
	4/10/1986	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	6/1/1989	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoprostenol	For the long-term intravenous treatment of pulmonary hypertension 
	associated with the scleroderma spectrum of disease in New York Heart 
	Association (NYHA) Class III and Class IV patients who do not respond 
	Trade Name:	adequately to conventional therapy.
	Flolan	Orphan Designation:
	Treatment of secondary pulmonary hypertension due to intrinsic 
	precapillary pulmonary vascular disease.  
	Designation 
	3/22/1999	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	4/14/2000	Five Moore Dr.
	PO Box 13398
	Research Triangle Park NC  27709-3398
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Epoprostenol	Long-term intravenous treatment of primary pulmonary hypertension in 
	NYHA Class III and Class IV patients.
	Trade Name:
	Flolan	Orphan Designation:
	Treatment of primary pulmonary hypertension.
	Designation 
	9/25/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	9/20/1995	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	etanercept	Reduction in signs and symptoms of moderately to severely active 
	polyarticular-course juvenile rheumatoid arthritis in patients who have had 
	an inadequate response to one or more disease-modifying anti-rheumatic 
	Trade Name:	drugs.
	Enbrel	Orphan Designation:
	Reduction in signs and symptoms of moderately to severely active 
	polyarticular-course juvenile rheumatoid arthritis in patients who have had 
	Designation 	an inadequate response to one or more disease-modifying anti-rheumatic 
	10/27/1998	Sponsor and Address	drugs.
	Marketing Exclusivity 	Immunex Corporation
	5/27/1999	51 University St.
	Seattle WA  98101-2936
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ethanolamine oleate
	Trade Name:
	Ethamolin	Orphan Designation:
	Treatment of patients with esophageal varices that have recently bled, to 
	prevent rebleeding.
	Designation 
	3/22/1984	Sponsor and Address
	Marketing Exclusivity 	Block Drug Company, Inc.
	12/22/1988	257 Cornelison Avenue
	Jersey City NJ  07302 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Etidronate disodium
	Trade Name:
	Didronel	Orphan Designation:
	Treatment of hypercalcemia of malignancy inadequately managed by 
	dietary modification and/or oral hydration.
	Designation 
	3/21/1986	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	4/21/1987	5775 West Old Shakoppe Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Exemestane	Treatment of advanced breast cancer in postmenopausal women whose 
	disease has progressed following tamoxifen therapy.
	Trade Name:
	Aromasin	Orphan Designation:
	Treatment of advanced breast cancer in postmenopausal women whose 
	disease has progressed following tamoxifen therapy.
	Designation 
	9/19/1991	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	10/21/1999	7000 Portage Road
	Mail Stop:  0636-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Felbamate	As adjunctive therapy in the treatment of partial and generalized seizures 
	associated with the Lennox-Gastaut syndrome in children.
	Trade Name:
	Felbatol	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	1/24/1989	Sponsor and Address
	Marketing Exclusivity 	Wallace Laboratories
	7/29/1993	301B College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	Treatment of patients with severe chronic neutropenia.
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of patients with severe chronic neutropenia (absolute neutrophil 
	count less than 500/mm3).
	Designation 
	11/7/1990	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/19/1994	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	Reduce the duration of neutropenia and neutropenia sequelae in patients 
	with non-myeloid malignancies undergoing ablative chemotherapy 
	followed by BMT.
	Trade Name:
	Neupogen	Orphan Designation:
	Treatment of neutropenia associated with bone marrow transplants.
	Designation 
	10/1/1990	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	6/15/1994	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Filgrastim	Reducing the time to neutrophil recovery and the duration of fever, 
	following induction or consolidation chemotherapy treatment of adults with 
	acute myeloid leukemia.
	Trade Name:
	Neupogen	Orphan Designation:
	Reduction in the duration of neutropenia, fever, antibiotic use, and 
	hospitalization, following induction and consolidation treatment for acute 
	Designation 	myeloid leukemia.
	11/7/1996	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	4/2/1998	One Amgen Center Dr.
	Thousand Oaks CA  91320-1799
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Filgrastim	For use in the mobilization of hematopoietic progenitor cells into the 
	peripheral blood collection by leukapheresis.
	Trade Name:
	Neupogen	Orphan Designation:
	For use in the mobilization of peripheral blood progenitor cells for 
	collection in patients who will receive myeloablative or myelosuppressive 
	Designation 	chemotherapy.
	7/17/1995	Sponsor and Address
	Marketing Exclusivity 	Amgen, Inc.
	12/28/1995	1840 Dehavilland Drive
	Thousand Oaks CA  91320 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fludarabine phosphate
	Trade Name:
	Fludara	Orphan Designation:
	Treatment of chronic lymphocytic leukemia (CLL), including refractory CLL.
	Designation 
	4/18/1989	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	4/18/1991	15049 San Pablo Avenue, P.O. Box 4099
	Richmond CA  94804 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fluocinolone	Treatment of chronic non-infectious uveitis affecting the posterior segment 
	of the eye
	Trade Name:
	Retisert	Orphan Designation:
	Treatment uveitis involving the posterior segment of the eye.
	Designation 
	7/31/2000	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb Pharmaceuticals, Inc.
	4/8/2005	8500 Hidden River Parkway
	Tampa FL  33637 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Follitropin alfa, recombinant	For the induction of spermatogenesis in men with primary and secondary 
	hypogonadotropic hypogonadism in whom the cause of infertility is not due
	 to primary testicular failure.
	Trade Name:
	Gonal-F	Orphan Designation:
	For the initiation and re-initiation of spermatogenesis in adult males with 
	reproductive failure due to hypothalamic or pituitary dysfunction, 
	Designation 	hypogonadotropic hypogonadism.  AMENDED indication 6/27/00:  For the 
	12/21/1998	induction of spermatogenesis in men with primary and secondary 
	hypogonadotropic hypogonadism in whom the cause of infertility is not due
	 to primary testicular failure.
	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	5/24/2000	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Fomepizole	Use for suspected or confirmed methanol poisoning, either alone or in 
	combination with hemodialysis
	Trade Name:
	Antizole	Orphan Designation:
	Treatment of methanol or ethylene glycol poisoning.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	12/8/2000	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fomepizole	As an antidote to ethylene glycol (antifreeze) poisoning, or for use in 
	suspected ethylene glycol ingestion.
	Trade Name:
	Antizole	Orphan Designation:
	Treatment of methanol or ethylene glycol poisoning.
	Designation 
	12/22/1988	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	12/4/1997	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Fosphenytoin	For the control of generalized convulsive status epilepticus.
	Trade Name:
	Cerebyx	Orphan Designation:
	For the acute treatment of patients with status epilepticus of the grand mal 
	type.
	Designation 
	6/4/1991	Sponsor and Address
	Marketing Exclusivity 	Warner-Lambert Company
	8/5/1996	2800 Plymouth Road
	Ann Arbor MI  48106 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gallium nitrate injection
	Trade Name:
	Ganite	Orphan Designation:
	Treatment of hypercalcemia of malignancy.
	Designation 
	12/5/1988	Sponsor and Address
	Marketing Exclusivity 	Solopak Pharmaceutical Co.
	1/17/1991	1845 Tonne Road
	Elk Grove Village IL  60007 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ganciclovir intravitreal implant	Treatment of CMV retinitis in patients with acquired immunodeficiency 
	syndrome.
	Trade Name:
	Vitrasert Implant	Orphan Designation:
	Treatment of cytomegalovirus retinitis.
	Designation 
	6/7/1995	Sponsor and Address
	Marketing Exclusivity 	Bausch & Lomb Surgical, Chiron Vision Products
	3/4/1996	9342 Jeronimo Road
	Irvine CA  92718-1903
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ganciclovir sodium
	Trade Name:
	Cytovene	Orphan Designation:
	Treatment of cytomegalovirus retinitis in immunocompromised patients 
	with AIDS.
	Designation 
	10/31/1985	Sponsor and Address
	Marketing Exclusivity 	Syntex (USA), Inc.
	6/23/1989	3401 Hillview Avenue
	Palo Alto CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gemtuzumab zogamicin	Treatment of patients with CD33 positive acute myeloid leukemia in first 
	relapse who are 60 years of age or older and who are not considered 
	candidates for cytotoxic chemotherapy
	Trade Name:
	Mylotarg	Orphan Designation:
	Treatment of CD33-positive acute myeloid leukemia.
	Designation 
	11/24/1999	Sponsor and Address
	Marketing Exclusivity 	Wyeth-Ayerst Laboratories
	5/17/2000	PO Box 8299
	Philadelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glatiramer acetate	For reduction of the frequency of relapses in patients with relapsing-
	remitting multiple sclerosis.
	Trade Name:
	Copaxone	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	11/9/1987	Sponsor and Address
	Marketing Exclusivity 	Teva Pharmaceuticals USA
	12/20/1996	1510 Delp Drive
	Kulpsville PA  19443 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Glutamine	Treatment of short bowel syndrome in patients receiving specialized 
	nutritional support when used in conjunction with a rercombinant human 
	growth hormone that is approved for this indication.
	Trade Name:
	NutreStore	Orphan Designation:
	For use with human growth hormone in the treatment of short bowel 
	syndrome (nutrient malabsorption from the gastrointestinal tract resulting 
	Designation 	from an inadequate absorptive surface).
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	Nutritional Restart Pharmaceutical, L.P.
	6/10/2004	4364 South Alston Avenue
	Durham NC  27713 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Gonadorelin acetate
	Trade Name:
	Lutrepulse	Orphan Designation:
	For induction of ovulation in women with hypothalamic amenorrhea due to 
	a deficiency or absence in the quantity or pulse pattern of endogenous 
	Designation 	GnRH secretion.
	4/22/1987	Sponsor and Address
	Marketing Exclusivity 	Ferring Laboratories, Inc.
	10/10/1989	400 Rella Boulevard, Suite 201
	Suffern NY  10901 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Halofantrine	Treatment of adults who can tolerate oral medication and who have mild to
	 moderate malaria caused by Plasmodium falciparum or Plasmodium 
	vivax.
	Trade Name:
	Halfan	Orphan Designation:
	Treatment of mild to moderate acute malaria caused by susceptible strains 
	of P. falciparum and P. vivax.
	Designation 
	11/4/1991	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	7/24/1992	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hemin
	Trade Name:
	Panhematin	Orphan Designation:
	Amelioration of recurrent attacks of acute intermittent porphyria (AIP) 
	temporarily related to the menstrual cycle in susceptible women and similar
	Designation 	 symptoms which occur in other patients with AIP, porphyria variegata and 
	3/16/1984	hereditary coproporphyria.
	Sponsor and Address
	Marketing Exclusivity 	Abbott Laboratories
	7/20/1983	Diagnostics Division
	Abbott Park IL  60064 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	hepatitis B immune globulin (human)	Prevention of hepatitis B recurrence following liver transplantation in 
	HBsAG-positive liver transplant patients
	Trade Name:
	HepaGam	Orphan Designation:
	Prevention of hepatitis B recurrence following orthotopic liver transplant
	Designation 
	3/24/2008	Sponsor and Address
	Marketing Exclusivity 	Cangene Corporation
	4/6/2007	155 Innovation Drive

	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histrelin 	Treatment of central precocious puberty
	Trade Name:
	Supprelin LA	Orphan Designation:
	Treatment of central precocious puberty
	Designation 
	11/18/2005	Sponsor and Address
	Marketing Exclusivity 	Indevus Pharmaceuticals (Formerly Valera Pharma.) 
	5/3/2007	33 Hayden Avenue
	Lexington MA  02421 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Histrelin acetate	Treatment of central precocious puberty.
	Trade Name:
	Supprelin Injection	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	8/10/1988	Sponsor and Address
	Marketing Exclusivity 	Roberts Pharmaceutical Corp.
	12/24/1991	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Hydroxocobalamin	Treatment on known or suspected cyanide poisoning
	Trade Name:
	Cyanokit	Orphan Designation:
	Treatment of acute cyanide poisoning
	Designation 
	11/25/2003	Sponsor and Address
	Marketing Exclusivity 	Merck Sante, s.a.a.
	12/15/2006	37  rue Saint Romain
	69008 Lyon
	    
	FRANCE
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Hydroxyurea	To reduce the frequency of painful crises and to reduce the need for blood 
	transfusions in adult patients with sickle cell anemia with recurrent 
	moderate to severe painful crises (generally at least 3 during the preceding 
	Trade Name:	12 months).  
	Droxia	Orphan Designation:
	Treatment of patients with sickle cell anemia as shown by the presence of 
	hemoglobin S.
	Designation 
	10/1/1990	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	2/25/1998	P.O. Box 4000
	Princeton NJ  08543 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ibritumomab tiuxetan	Treatment of patients with relapsed or refractory low-grade, follicular, or 
	transformed B-cell non-Hodgkin?s lymphoma, including patients with 
	Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma
	Trade Name:
	Zevalin	Orphan Designation:
	Treatment of B-cell non-Hodgkin's lymphoma.
	Designation 
	9/6/1994	Sponsor and Address
	Marketing Exclusivity 	Biogen IDEC Inc.
	2/19/2002	5200 research Place
	San Diego CA  92122 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ibuprofen lysine	For closure of a clinically significant patent ductus arteriosus in premature 
	infants weighing between 500 and 1500 g, who are no more than 32 weeks 
	gestational age when usual medical management (e.g., fluid restriction, 
	Trade Name:	diuretics, respiratory support, etc.) is  ineffective
	NeoProfen	Orphan Designation:
	Treatment of patent ductus arteriosus.
	Designation 
	10/29/1996	Sponsor and Address
	Marketing Exclusivity 	Farmacon-IL, LLC
	4/13/2006	1720 Post Road East
	Suite 213
	Westport CT  06880-5643
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Icodextrin 7.5% with Electrolytes Peritoneal Dialysis 	For use as a single daily exchange for the long (8-16 hour) dwell during 
	Solution	continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal 
	dialysis (APD) for the management of chronic renal failure.
	Trade Name:
	Extraneal (with 7.5% Icodextrin) Peritoneal 	Orphan Designation:
	Dialysis Solutio
	Treatment of those patients having end stage renal disease and requiring 
	peritoneal dialysis treatment.
	Designation 
	7/18/1997	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	12/20/2002	Renal Division
	1620 Waukegan Road
	McGaw Park IL  60085 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Idarubicin HCl for injection
	Trade Name:
	Idamycin	Orphan Designation:
	Treatment of acute myelogenous leukemia, also referred to as acute 
	nonlymphocytic leukemia.
	Designation 
	7/25/1988	Sponsor and Address
	Marketing Exclusivity 	Adria Laboratories, Inc.
	9/27/1990	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	idursulfase	Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS
	 II).  Idursulfase has been shown to improve walking capacity in these 
	patients
	Trade Name:
	Elaprase	Orphan Designation:
	Long term enzyme replacement therapy for patients with 
	mucopolysaccharidosis II (Hunter Syndrome)
	Designation 
	11/28/2001	Sponsor and Address
	Marketing Exclusivity 	Shire Human Genetic Therapies, Inc.
	7/24/2006	700 Main Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ifosfamide	In combination with certain other approved antineoplastic agents, for third 
	line chemotherapy in the treatment of germ cell testicular cancer.
	Trade Name:
	Ifex	Orphan Designation:
	Treatment of testicular cancer.
	Designation 
	1/20/1987	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	12/30/1988	5 Research Parkway, P.O. Box 5100
	Wallingford CT  06492 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iloprost inhalation solution	Treatment of pulmonary arterial hypertension (WHO Group I) in patients 
	with NYHA Class III or IV symptoms
	Trade Name:
	Ventavis	Orphan Designation:
	Treatment of pulmonary arterial hypertension
	Designation 
	8/17/2004	Sponsor and Address
	Marketing Exclusivity 	CoTherix, Inc.
	12/29/2004	5000 Shoreline Court
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib	Treatment of patients with chronic myeloid
	leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after 
	failure of interferon-alpha therapy
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	1/31/2001	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	5/10/2001	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with aggressive mastocytosis (ASM) without the 
	D816V c-Kit mutation or with c-Kit mutational status unknown
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of systemic mastocytosis without the D816V c-kit mutation
	Designation 
	9/9/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with myelodysplastic/myeloproliferative 
	diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor 
	receptor) gene re-arrangements
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of myeloproliferative disorders/myelodysplastic syndromes 
	associated with platelet-derived growth factor gene re-arrangements
	Designation 
	10/5/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imatinib mesylate	Treatment of adult patients with hypereosinophic syndrome (HES) and/or 
	chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRÎ± fusion 
	kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion)
	Trade Name:	 and for patients with HES and/or CEL who are FIP1L1-PDGFRÎ± fusion 
	kinase negative or unknown
	Gleevec	Orphan Designation:
	Treatment of idiopathic hypereosinophilic syndrome including acute and 
	chronic eosinophilic leukemia
	Designation 
	8/25/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of adult patients with relapsed or refractory Philadelphia 
	chromosome positive acute lymphoblastic leukemia (Ph+ALL)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of Philadelphia-positive acute lymphoblastic leukemia
	Designation 
	10/11/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of adult patients with unresectable, recurrent and/or metastatic 
	dermatofibrosarcoma protuberans (DFSP)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of dermatofibrosarcoma protuberans
	Designation 
	12/19/2005	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	10/19/2006	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	imatinib mesylate	Treatment of patients with Kit (CD117) positive unresectable and/or 
	metastatic malignant gastrointestinal stromal tumors (GIST)
	Trade Name:
	Gleevec	Orphan Designation:
	Treatment of gastrointestinal  stromal tumors
	Designation 
	11/1/2001	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	2/1/2002	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Imiglucerase	Enzyme replacement therapy in patients with type I Gaucher's disease.
	Trade Name:
	Cerezyme	Orphan Designation:
	Replacement therapy in patients with types I, II, and III Gaucher's disease.
	Designation 
	11/5/1991	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	5/23/1994	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Immune globulin intravenous, human	For prophylaxis of children with clinical or immunologic evidence of human
	 immunodeficiency virus to decrease the frequency of serious and minor 
	bacterial infections and the frequency of hospitalization, and to increase 
	Trade Name:	the time free of serious bacterial infections.
	Gamimune N	Orphan Designation:
	Infection prophylaxis in pediatric patients affected with the human 
	immunodeficiency virus.
	Designation 
	2/18/1993	Sponsor and Address
	Marketing Exclusivity 	Bayer Corporation
	12/27/1993	Pharmaceutical Division, Biological Products
	400 Morgan Lane
	New Haven CT  06516 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Infliximab	For reducing signs and symptoms and inducing and maintaining clinical 
	remission in pediatric patients with moderately to severely active Crohn's 
	disease who have had an inadequate response to conventional therapy
	Trade Name:
	REMICADE	Orphan Designation:
	Treatment of pediatric (0 to 16 years of age) Crohn's Disease
	Designation 
	11/12/2003	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	5/19/2006	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Infliximab	Treatment of moderately to severely active Crohn's disease for the 
	reduction of the signs and symptoms, in patients who have an inadequate 
	response to conventional therapies; and treatment of patients with 
	Trade Name:	fistulizing Crohn's disease for the reduction in the number of draining 
	Remicade	Orphan Designation:
	Treatment of moderately to severely active Crohn's disease for the 
	reduction of the signs and symptoms, in patients who have an inadequate 
	Designation 	response to conventional therapy; and treatment of patients with fistulizing 
	11/14/1995	Crohn's disease for the reduction in the number of draining 
	Sponsor and Address
	Marketing Exclusivity 	Centocor, Inc.
	8/24/1998	200 Great Valley Parkway
	Malvern PA  19355-1307
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a	Treatment of chronic myelogenous leukemia.
	Trade Name:
	Roferon A	Orphan Designation:
	Treatment of chronic myelogenous leukemia.
	Designation 
	6/6/1989	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	10/19/1995	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2a (recombinant)
	Trade Name:
	Roferon-A	Orphan Designation:
	Treatment of AIDS related Kaposi's sarcoma.
	Designation 
	12/14/1987	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	11/21/1988	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon alfa-2b (recombinant)	Treatment of selected patients with AIDS-related Kaposi's sarcoma.
	Trade Name:
	Intron A	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	6/24/1987	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	11/21/1988	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1a	Treatment of relapsing forms of multiple sclerosis to slow the accumulation 
	of physical disability and decrease the frequency of clinical exacerbations.
	Trade Name:
	Avonex	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	12/16/1991	Sponsor and Address
	Marketing Exclusivity 	Biogen, Inc.
	5/17/1996	14 Cambridge Center
	Cambridge MA  02142 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon beta-1b	In ambulatory patients with relapsing-remitting multiple sclerosis to reduce 
	the frequency of clinical exacerbations.
	Trade Name:
	Betaseron	Orphan Designation:
	Treatment of multiple sclerosis.
	Designation 
	11/17/1988	Sponsor and Address
	Marketing Exclusivity 	Chiron Corp. & Berlex Laboratories
	7/23/1993	4560 Horton Street
	Emeryville CA  94608 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Interferon gamma 1-b
	Trade Name:
	Actimmune	Orphan Designation:
	Treatment of chronic granulomatous disease.
	Designation 
	9/30/1988	Sponsor and Address
	Marketing Exclusivity 	InterMune, Inc.
	12/20/1990	3280 Bayshore Blvd
	Brisbane CA  94005 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Interferon gamma-1b	Delaying time to disease progression in patients with severe, malignant 
	osteopetrosis.
	Trade Name:
	Actimmune	Orphan Designation:
	Delaying time to disease progression in patients with severe, malignant 
	osteopetrosis.
	Designation 
	9/30/1996	Sponsor and Address
	Marketing Exclusivity 	InterMune , Inc.
	2/10/2000	1710 Gilbreth Road, 
	Suite 301
	Burlingame CA  94010-1317
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Iobenguane Sulfate I 131	Adjunctive diagnostic agent in the localization of primary or metastatic 
	pheochromocytomas.
	Trade Name:
	Orphan Designation:
	For use as a diagnostic adjunct in patients with pheochromocytoma.
	Designation 
	11/14/1984	Sponsor and Address
	Marketing Exclusivity 	University of Michigan
	3/21/1990	UH B1 H410/0028
	1500 E. Medical Center Drive
	Ann Arbor MI  48109-0028
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	iron(III)-hexacyanoferrate(II)	Treatment of patients with known or suspected internal contamination with 
	radioactive cesium and/or radioactive or non-radioactive thallium to 
	increase their rates of elimination
	Trade Name:
	Radiogardase	Orphan Designation:
	Treatment of patients with known or suspected internal contamination with 
	radioactive or non-radioactive cesium or thallium
	Designation 
	5/1/2003	Sponsor and Address
	Marketing Exclusivity 	Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG
	10/2/2003	Goerzallee 253
	D-14167 Berlin, Federal Republic of Germany
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lamotrigine	Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult 
	patients.
	Trade Name:
	Lamictal	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	8/23/1995	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Research and Development
	8/24/1998	5 Moore Drive
	P.O. Box 13398
	Research Triangle Park NC  27709 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Lanreotide	Long-term treatment of acromegalic patients who have had an inadequate 
	response to or cannot be treated with surgery and/or radiotherapy
	Trade Name:
	Somatuline Depot	Orphan Designation:
	Treatment for acromegly
	Designation 
	9/11/2000	Sponsor and Address
	Marketing Exclusivity 	IPSEN, Inc.
	8/30/2007	27 Maple Street
	Milford MA  01757 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	laronidase	Treatment for patients with Hurler and Hurler-Scheie forms of 
	Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who 
	have moderate to severe symptoms
	Trade Name:
	Aldurazyme	Orphan Designation:
	Treatment of patients with mucopolysaccharidosis-I.  
	Designation 
	9/24/1997	Sponsor and Address
	Marketing Exclusivity 	BioMarin Pharmaceutical, Inc.
	4/30/2003	371 Bel Marin Keys Boulevard, Suite 210
	Novato CA  94949-5608
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lenalidomide	Treatment of patients with transfusion dependant anemia due to low or 
	intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 
	q cytogenetic abnormality with or without additional cytogenetic 
	Trade Name:	abnormalities
	Revlimid	Orphan Designation:
	Treatment of myelodysplastic syndromes
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	12/27/2005	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	lenalidomide	For use in combination with dexamethasone for the treatment of multiple 
	myeloma patients who have received at least one prior therapy.
	Trade Name:
	Revlimid 	Orphan Designation:
	Treatment for multiple myeloma
	Designation 
	9/20/2001	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	6/29/2006	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lepirudin	For anticoagulation in patients with heparin-induced thrombocytopenia and
	 associated thromboembolic disease in order to prevent further 
	thromboembolic complications.
	Trade Name:
	Refluden	Orphan Designation:
	Treatment of heparin-associated thrombocytopenia type II.
	Designation 
	2/13/1997	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	3/6/1998	Frankfurt am Main
	P.O. Box 1140
	Marburg     
	GERMANY
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Leucovorin	For use in combination with 5-fluorouracil to prolong survival in the 
	palliative treatment of patients with advanced colorectal cancer.
	Trade Name:
	Leucovorin calcium	Orphan Designation:
	For use in combination with 5-fluorouracil for the treatment of metastatic 
	colorectal cancer.
	Designation 
	12/8/1986	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	12/12/1991	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leucovorin
	Trade Name:
	Leucovorin calcium	Orphan Designation:
	For rescue use after high dose methotrexate therapy in the treatment of 
	osteosarcoma.
	Designation 
	8/17/1988	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	8/31/1988	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Leuprolide acetate	Treatment of children with central precocious puberty.
	Trade Name:
	Lupron Injection	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	7/25/1988	Sponsor and Address
	Marketing Exclusivity 	Tap Pharmaceuticals, Inc.
	4/16/1993	2355 Waukegan Road
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine	Prevention and treatment of carnitine deficiency in patients with end stage 
	renal disease who are undergoing dialysis.  
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of manifestations of carnitine deficiency in patients with end 
	stage renal disease who require dialysis.
	Designation 
	9/6/1988	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	12/15/1999	800 South Frederick Avenue, Suite 300
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levocarnitine	Treatment of primary systemic carnitine deficiency. (approved 12/27/85)  
	Treatment of secondary carnitine deficiency. (approved 12/16/92)
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of primary and secondary carnitine deficiency of genetic origin.
	Designation 
	7/26/1984	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	12/16/1992	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Levocarnitine
	Trade Name:
	Carnitor	Orphan Designation:
	Treatment of genetic carnitine deficiency.
	Designation 
	2/28/1984	Sponsor and Address
	Marketing Exclusivity 	Sigma-Tau Pharmaceuticals, Inc.
	4/10/1986	800 South Frederick Avenue
	Gaithersburg MD  20877 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levoleucovorin	Levoleucovorin rescue is indicated after high-dose methotrexate therapy in 
	osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and 
	counteract the effects of impaired methotrexate elimination and of 
	Trade Name:	inadvertent overdosage of folic acid antagonists
	Orphan Designation:
	For use in conjunction with high-dose methotrexate in the treatment of 
	osteosarcoma.
	Designation 
	8/1/1991	Sponsor and Address
	Marketing Exclusivity 	Spectrum Pharmaceuticals, Inc.
	3/7/2008	157 Technology Drive
	Irgine CA  92618 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Levomethadyl acetate hydrochloride	For the management of opiate dependence.
	Trade Name:
	Orlaam	Orphan Designation:
	Treatment of heroin addicts suitable for maintenance on opiate agonists.
	Designation 
	1/24/1985	Sponsor and Address
	Marketing Exclusivity 	Biodevelopment Corporation
	7/9/1993	8180 Greensboro Drive, Suite 1000
	McLean VA  22102 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lidocaine patch 5%
	Trade Name:
	Lidoderm Patch	Orphan Designation:
	For relief of allodynia (painful hypersensitivity), and chronic pain in 
	postherpetic neuralgia. 
	Designation 
	10/24/1995	Sponsor and Address
	Marketing Exclusivity 	Teikoku Pharma USA, Inc.
	3/19/1999	745-D Camden Ave.
	Campbell CA  95008-4146
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liothyronine sodium injection	Treatment of myxedema coma/precoma.
	Trade Name:
	Triostat	Orphan Designation:
	Treatment of myxedema coma/precoma.
	Designation 
	7/30/1990	Sponsor and Address
	Marketing Exclusivity 	SmithKline Beecham Pharmaceuticals
	12/31/1991	One Franklin Plaza
	P.O. Box 7929
	Philadelphia PA  19101 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Liposomal amphotericin B	Treatment of visceral leishmaniasis.
	Trade Name:
	AmBisome	Orphan Designation:
	Treatment of visceral leishmaniasis.
	Designation 
	12/6/1996	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	8/11/1997	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Liposomal amphotericin B	Treatment of disseminated cryptococcosis including meningitis.
	Trade Name:
	AmBisome	Orphan Designation:
	Treatment of cryptococcal meningitis.
	Designation 
	12/10/1996	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	8/11/1997	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Lodoxamide tromethamine	Treatment of ocular disorders referred to by the terms vernal 
	keratoconjunctivitis, vernal conjunctivitis, vernal keratitis.
	Trade Name:
	Alomide Ophthalmic Solution	Orphan Designation:
	Treatment of vernal keratoconjunctivitis.
	Designation 
	10/16/1991	Sponsor and Address
	Marketing Exclusivity 	Alcon Laboratories, Inc.
	9/23/1993	6201 South Freeway
	Fort Worth TX  76134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mafenide acetate solution
	Trade Name:
	Sulfamylon solution	Orphan Designation:
	For use as an adjunctive topical antimicrobial agent to control bacterial 
	infection when used under moist dressings over meshed autografts on 
	Designation 	excised burn wounds. 
	7/18/1990	Sponsor and Address
	Marketing Exclusivity 	Mylan Laboratories, Inc.
	6/5/1998	781 Chestnut Ridge Road
	P.O. Box 4310
	Morgantown WV  26504-4310
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mecasermin	Long-term treatment of growth failure in children with severe primary IGF-1 
	deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who 
	have developed neutralizing antibodies to growth hormone.  
	Trade Name:
	Increlex	Orphan Designation:
	Treatment of growth hormone insensitivity syndrome.
	Designation 
	12/12/1995	Sponsor and Address
	Marketing Exclusivity 	Tercica, Inc.
	8/30/2005	2000 Sierra Point Parkway
	Suite 400
	Brisbane CA  94005 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	mecasermin rinfabate	Treatment of growth failure in children with severe primary IGF-1 deficiency
	 (Primary IGFD) or with growth hormone (GH) gene deletion who have 
	developed neutralizing antibodies to growth hormone
	Trade Name:
	iPLEX	Orphan Designation:
	Treatment of growth hormone insensitivity syndrome (GHIS)
	Designation 
	5/17/2002	Sponsor and Address
	Marketing Exclusivity 	Insmed, Inc.
	12/12/2005	8720 Stony Point Parkway
	Suite 200
	Richmond VA  23235 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Lariam	Orphan Designation:
	Prophylaxis of Plasmodium falciparum malaria which is resistant to other 
	available drugs.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	5/2/1989	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mefloquine HCl
	Trade Name:
	Lariam	Orphan Designation:
	Treatment of acute malaria due to Plasmodium falciparum and 
	Plasmodium vivax.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	5/2/1989	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Megestrol acetate	Treatment of anorexia, cachexia, or an unexplained significant weight loss 
	in patients with a diagnosis of acquired immune deficiency syndrome.
	Trade Name:
	Megace	Orphan Designation:
	Treatment of patients with anorexia, cachexia, or significant weight loss 
	(=/>10% of baseline body weight) and confirmed diagnosis of AIDS.
	Designation 
	4/13/1988	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	9/10/1993	2400 West Lloyd Expressway
	Evansville IN  47721 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	meloxicam	For relief of the signs and symptoms of pauciarticular or polyarticular course
	 Juvenile Rheumatoid Arthritis in patients 2 years of age or older
	Trade Name:
	Mobic	Orphan Designation:
	Treatment of juvenile rheumatoid arthritis
	Designation 
	11/22/2002	Sponsor and Address
	Marketing Exclusivity 	Boehringer Ingelheim Pharmaceuticals, Inc.
	8/11/2005	900 Ridgebury Road
	P. O. Box 368
	Ridgefield CT  06877-0368
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Melphalan	For the palliative treatment of patients with multiple myeloma for whom 
	oral melphalan is not appropriate.
	Trade Name:
	Alkeran For Injection	Orphan Designation:
	Treatment of patients with multiple myeloma for whom oral therapy is 
	inappropriate.
	Designation 
	2/24/1992	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	11/18/1992	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mesna
	Trade Name:
	Mesnex	Orphan Designation:
	For use as a prophylactic agent in reducing the incidence of ifosfamide-
	induced hemorrhagic cystitis.
	Designation 
	11/14/1985	Sponsor and Address
	Marketing Exclusivity 	Degussa Corporation
	12/30/1988	65 Challenger Road
	Ridgefield Park NJ  07660 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Methotrexate sodium	For the use of high dose methotrexate with leucovorin rescue in patients 
	with non-metastatic osteosarcoma who have undergone surgical resection 
	or amputation for the primary tumor.
	Trade Name:
	Methotrexate	Orphan Designation:
	Treatment of osteogenic sarcoma.
	Designation 
	10/21/1985	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories
	4/7/1988	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Metronidazole (topical)
	Trade Name:
	Metrogel	Orphan Designation:
	Treatment of acne rosacea.
	Designation 
	10/22/1987	Sponsor and Address
	Marketing Exclusivity 	Galderma Laboratories, Inc.
	11/22/1988	P.O. Box 331329
	Fort Worth TX  76163 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Midodrine HCl	Treatment of symptomatic orthostatic hypotension.
	Trade Name:
	Amatine	Orphan Designation:
	Treatment of patients with symptomatic orthostatic hypotension.
	Designation 
	12/5/1996	Sponsor and Address
	Marketing Exclusivity 	Schier Ridgewood          F.K.A. (Roberts Pharmaceutical Corp.)
	9/6/1996	Meridian Center III
	6 Industrial Way West
	Eatontown NJ  07724 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	miglustat	Treatment of mild to moderate Type I Gaucher disease in adults for whom 
	enzyme replacement therapy is not a therapeutic option (e.g., due to 
	constraints such as allergy, hypersensitivity, or poor venous access). 
	Trade Name:
	Zavesca	Orphan Designation:
	Treatment of Gaucher disease.
	Designation 
	5/29/1998	Sponsor and Address
	Marketing Exclusivity 	Actelion  Pharmaceuticals Ltd
	7/31/2003	Gewerbestrasse 16
	CH - 4123 Allschwi
	    
	SWITZERLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone	In combination with corticosteroids as initial chemotherapy for the 
	treatment of patients with pain related to advanced hormone-refractory 
	prostate cancer.
	Trade Name:
	Novantrone	Orphan Designation:
	Treatment of hormone refractory prostate cancer.
	Designation 
	8/21/1996	Sponsor and Address
	Marketing Exclusivity 	Serono
	11/13/1996	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone	Reducing neurologic disability and/or the frequency of clinical relapses in 
	patients with secondary (chronic) progressive, progressive relapsing, or 
	worsening relapsing-remitting multiple sclerosis (i.e., patients whose 
	Trade Name:	neurologic status is significantly adnormal between relapses).
	Novantrone	Orphan Designation:
	Treatment of secondary-progressive multiple sclerosis.
	Designation 
	8/13/1999	Sponsor and Address
	Marketing Exclusivity 	Serono, Inc.
	10/13/2000	One Technoloogy Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone	Reducing neurologic disability and/or the frequency of clinical relapses in 
	patients with secondary (chronic) progressive, progressive relapsing, or 
	worsening relapsing-remitting multiple sclerosis (i.e., patients whose 
	Trade Name:	neurologic status is significantly adnormal between relapses).
	Novantrone	Orphan Designation:
	Treatment of progressive-relapsing multiple sclerosis.
	Designation 
	8/13/1999	Sponsor and Address
	Marketing Exclusivity 	Serono, Inc.
	10/13/2000	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Mitoxantrone HCl
	Trade Name:
	Novantrone	Orphan Designation:
	Treatment of acute myelogenous leukemia, also referred to as acute 
	nonlymphocytic leukemia.
	Designation 
	7/13/1987	Sponsor and Address
	Marketing Exclusivity 	Lederle Laboratories
	12/23/1987	Division of American Cyanamid Company
	401 N. Middletown Road
	Pearl River NY  10965 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Modafinil	Improve wakefulness in patients with excessive daytime sleepiness 
	associated with narcolepsy.
	Trade Name:
	Provigil	Orphan Designation:
	Treatment of excessive daytime sleepiness in narcolepsy.
	Designation 
	3/15/1993	Sponsor and Address
	Marketing Exclusivity 	Cephalon, Inc.
	12/24/1998	145 Brandywine Parkway
	West Chester PA  19380 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Monooctanoin
	Trade Name:
	Moctanin	Orphan Designation:
	For dissolution of cholesterol gallstones retained in the common bile duct.
	Designation 
	5/30/1984	Sponsor and Address
	Marketing Exclusivity 	Ethitek Pharmaceuticals, Inc.
	10/31/1985	7855 Gross Point Road, Unit L
	Skokie IL  60077 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Morphine sulfate concentrate (preservative free)	For intrathecal or epidural infusion in the treatment of tractable chronic 
	pain. It was developed for use in continuous microinfusion devices and may
	 require dilution before use as directed.
	Trade Name:
	Infumorph	Orphan Designation:
	For use in microinfusion devices for intraspinal administration in the 
	treatment of intractable chronic pain.
	Designation 
	7/12/1990	Sponsor and Address
	Marketing Exclusivity 	Elkins-Sinn, Inc.
	7/19/1991	2 Esterbrook Lane
	Cherry Hill NJ  08003 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	multi-vitiam infusion without vitamin K	Prevention of vitamin deficiency and thrombormbolic complications in 
	people receiving home parenteral nutrition who also receive warfarin-type 
	anticoagulant therapy
	Trade Name:
	M.V.I.-12	Orphan Designation:
	Prevention of vitamin deficiency and thromboembolic complications
	in people receiving home parenteral nutrition and warfarin-type 
	Designation 	anticoagulant therapy
	3/8/2004	Sponsor and Address
	Marketing Exclusivity 	Mayne Pharma (USA) Inc.
	9/9/2004	Mack-Cali Centre II
	Second Floor
	Paramus NJ  07652 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	N-acetylgalactosamine-4-sulfatase, recombinant 	For patients with mucopolysaccharidosis VI.  Galsulfase has been shown to 
	human	improve walking and stair-climbing capacity.
	Trade Name:
	Naglazyme	Orphan Designation:
	Treatment of mucopolysaccharidosis Type VI (Maroteaux-Lamy syndrome).
	Designation 
	2/17/1999	Sponsor and Address
	Marketing Exclusivity 	BioMarin Pharmaceutical, Inc.
	5/31/2005	105 Digital Drive
	Novato CA  94949-5608
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Nafarelin acetate	Treatment of central precocious puberty (gonadotropin-dependent 
	precocious puberty) in children of both sexes.
	Trade Name:
	Synarel Nasal Solution	Orphan Designation:
	Treatment of central precocious puberty.
	Designation 
	7/20/1988	Sponsor and Address
	Marketing Exclusivity 	Syntex (USA), Inc.
	2/26/1992	3401 Hillview Avenue
	Palo Alto CA  94303 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Naltrexone HCl
	Trade Name:
	Trexan	Orphan Designation:
	For blockade of the pharmacological effects of exogenously administered 
	opioids as an adjunct to the maintenance of the opioid-free state in 
	Designation 	detoxified formerly opioid-dependent individuals.
	3/11/1985	Sponsor and Address
	Marketing Exclusivity 	DuPont Pharmaceuticals
	11/30/1984	E.I. Du Pont De Nemours & Co.
	Wilmington DE  19880 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	nelarabine	Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell 
	lymphoblastic lymphoma whose disease has not responded to or has 
	relapsed following treatment with at least two chemotherapy regimens
	Trade Name:
	Arranon	Orphan Designation:
	Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma
	Designation 
	8/10/2004	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	10/28/2005	One Franklin Plaza
	Phildelphia PA  19101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nilotinib	For the use for chronic phase (CP) and accelerated phase (AP) Philadelphia
	 chromosome positive chronic myelogenous leukemia  (CML) in adult 
	patients resistant to or intolerant to prior therapy that included 
	Trade Name:	GleevecÃÂ®(imatinib)
	Tasigna	Orphan Designation:
	Treatment of chronic myelogenous leukemia
	Designation 
	4/27/2006	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceutical Corporation
	10/29/2007	One Health Plaza
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	nitazoxanide	Treatment of diarrhea caused by Cryptosporidium parvum and Giardia 
	lamblia
	Trade Name:
	Alinia	Orphan Designation:
	Treatment of intestinal giardiasis
	Designation 
	2/14/2002	Sponsor and Address
	Marketing Exclusivity 	Romark Laboratories, L.C.
	11/22/2002	6200 Courtney Campbell Causeway
	Suite 880
	Tampa FL  33607 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Nitazoxanide	Treatment of diarrhea caused by Cryptosporidium parvum and Giardia 
	lamblia
	Trade Name:
	Alinia	Orphan Designation:
	Treatment of cryptosporidiosis.
	Designation 
	12/12/1996	Sponsor and Address
	Marketing Exclusivity 	Romark Laboratories, L.C.
	11/22/2002	6200 Courtney Campbell Causeway
	Suite 880
	Tampa FL  33607 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitisinone	Adjunctive therapy to dietary  restriction of tyrosine and phenylalanine in 
	the treatment of hereditary tyrosinemia type 1
	Trade Name:
	Orfadin	Orphan Designation:
	Treatment of tyrosinemia type 1.
	Designation 
	5/16/1995	Sponsor and Address
	Marketing Exclusivity 	Swedish Orphan AB
	1/18/2002	Drottninggatan 98
	SE-111 60 Stockholm
	    
	SWEDEN
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Nitric oxide	In conjunction with ventilatory support and other appropriate agents, in the 
	treatment of term and near-term (>34 weeks) neonates with hypoxic 
	respiratory failure associated with clinical or echocardiographic evidence of 
	Trade Name:	pulmonary hypertension, where it improves oxygenation and reduces the 
	need for extracorporeal membrane oxygenation.
	INOmax	Orphan Designation:
	Treatment of persistent pulmonary hypertension in the newborn.
	Designation 
	6/22/1993	Sponsor and Address
	Marketing Exclusivity 	INO Therapeutics, Inc.
	12/23/1999	54 Old Highway 22
	Clinton NJ  08809 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Octreotide	Supression of severe diarrhea and flushing associated with malignant 
	carcinoid syndrome.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of severe diarrhea and flushing associated with malignant 
	carcinoid tumors.
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Octreotide	Reduction of growth hormone and IGF-1 (somatomedin C) in acromegaly.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of acromegaly.
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Octreotide	Treatment of profuse watery diarrhea associated with VIPoma.
	Trade Name:
	Sandostatin LAR	Orphan Designation:
	Treatment of diarrhea associated with vasoactive intestinal peptide tumors 
	(VIPoma).
	Designation 
	8/24/1998	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corporation
	11/25/1998	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Ofloxacin	Treatment of bacterial corneal ulcers.
	Trade Name:
	Ocuflox Ophthalmic Solution	Orphan Designation:
	Treatment of bacterial corneal ulcers.
	Designation 
	4/18/1991	Sponsor and Address
	Marketing Exclusivity 	Allergan, Inc.
	5/22/1996	2525 Dupont Drive
	P.O. Box 19534
	Irvine CA  92713 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Oprelvekin
	Trade Name:
	Neumega	Orphan Designation:
	Prevention of severe chemotherapy-induced thrombocytopenia. 
	Designation 
	12/17/1996	Sponsor and Address
	Marketing Exclusivity 	Genetics Institute, Inc.
	11/25/1997	87 Cambridge Park Drive
	Cambridge MA  02140 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	ortezomib	Treatment of multiple myeloma patients who have received at least two 
	prior therapies and have demonstrated disease progression on the last 
	therapy
	Trade Name:
	Velcade	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	1/15/2003	Sponsor and Address
	Marketing Exclusivity 	Millennium Pharmaceuticals, Inc.
	5/13/2003	40 Landsdowne Street
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	oxybate	Treatment of excessive daytime sleepiness in patients with narcolepsy
	Trade Name:
	Xyrem	Orphan Designation:
	Treatment of narcolepsy
	Designation 
	11/7/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	11/18/2005	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	oxybate	Treatment of cataplexy associated with narcolepsy.
	Trade Name:
	 Xyrem	Orphan Designation:
	Treatment of narcolepsy.
	Designation 
	11/7/1994	Sponsor and Address
	Marketing Exclusivity 	Jazz Pharmaceuticals
	7/17/2002	3180 Porter Drive
	Palo Alto  CA  94304 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Paclitaxel	For the second line treatment of AIDS-related Kaposi's sarcoma.
	Trade Name:
	Taxol	Orphan Designation:
	Treatment of AIDS-related Kaposi's sarcoma.
	Designation 
	3/25/1997	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	8/4/1997	5 Research Parkway
	P.O. Box 5100
	Wallingford CT  06492-7660
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegademase bovine
	Trade Name:
	Adagen	Orphan Designation:
	For enzyme replacement therapy for ADA deficiency in patients with severe 
	combined immunodeficiency.
	Designation 
	5/29/1984	Sponsor and Address
	Marketing Exclusivity 	Enzon, Inc.
	3/21/1990	20 Kingsbridge Road
	Piscataway NJ  08854 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegaspargase	Combination chemotherapy for the treatment of patients with acute 
	lymphoblastic leukemia who are hypersensitive to native forms of L-
	asparaginase.
	Trade Name:
	Oncaspar	Orphan Designation:
	Treatment of acute lymphocytic leukemia.
	Designation 
	10/20/1989	Sponsor and Address
	Marketing Exclusivity 	Enzon, Inc.
	2/1/1994	20 Kingsbridge Road
	Piscataway NJ  08854 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pegvisomant	Treatment of acromegaly in patients who have had an inadequate 
	response to surgery and/or radiation therapy and/or other medical therapies,
	 or for whom these therapies are not appropriate
	Trade Name:
	Somavert	Orphan Designation:
	Treatment of acromegaly.
	Designation 
	6/24/1997	Sponsor and Address
	Marketing Exclusivity 	Sensus Corporation
	3/25/2003	Suite 430,
	98 San Jacinto Boulevard
	Austin TX  78701 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	pemetrexed disodium	Treatment of patients with malignant pleural mesothelioma whose disease 
	is either unresectable or who are otherwise not candidates for curative 
	surgery
	Trade Name:
	Alimta	Orphan Designation:
	Treatment of malignant pleural mesothelioma
	Designation 
	8/28/2001	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	2/4/2004	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate
	Trade Name:
	Nebupent	Orphan Designation:
	Prevention of Pneumocystis carinii pneumonia in patients at high risk of 
	developing this disease.
	Designation 
	1/12/1988	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	6/15/1989	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentamidine isethionate
	Trade Name:
	Pentam 300	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia.
	Designation 
	2/28/1984	Sponsor and Address
	Marketing Exclusivity 	Fujisawa USA, Inc.
	10/16/1984	3 Parkway North Center
	Deerfield IL  60015 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentastarch
	Trade Name:
	Pentaspan	Orphan Designation:
	As an adjunct in leukapheresis to improve the harvesting and increase the 
	yield of leukocytes by centrifugal means.
	Designation 
	8/28/1985	Sponsor and Address
	Marketing Exclusivity 	Du Pont Pharmaceuticals
	5/19/1987	E.I. Du Pont De Nemours & Co.
	Wilmington DE  19898 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pentosan polysulfate sodium	Relief of bladder pain or discomfort associated with interstitial cystitis.
	Trade Name:
	Elmiron	Orphan Designation:
	Treatment of interstitial cystitis.
	Designation 
	8/7/1985	Sponsor and Address
	Marketing Exclusivity 	Alza Corporation
	9/26/1996	950 Page Mill Rd.
	PO Box 10950
	Palo Alto CA  94303-0802
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Pentostatin for injection	Single agent treatment for adult patients with alpha-interferon-refractory 
	hairy cell leukemia.
	Trade Name:
	Nipent	Orphan Designation:
	Treatment of hairy cell leukemia.
	Designation 
	9/10/1987	Sponsor and Address
	Marketing Exclusivity 	SuperGen, Inc.
	10/11/1991	4140 Dublin Blvd.
	Suite 200
	Dublin CA  94568 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pilocarpine	Treatment of symptoms of xerostomia from salivary gland hypofunction 
	caused by radiotherapy for cancer of the head and neck.
	Trade Name:
	Salagen	Orphan Designation:
	Treatment of xerostomia induced by radiation therapy for head and neck 
	cancer.
	Designation 
	9/24/1990	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	3/22/1994	5775 West Old Shakopee Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pilocarpine HCl	Treatment of dry mouth in patients with Sjogren's syndrome.
	Trade Name:
	Salagen	Orphan Designation:
	Treatment of xerostomia and keratoconjunctivitis sicca in Sjogren's 
	syndrome patients.
	Designation 
	2/28/1992	Sponsor and Address
	Marketing Exclusivity 	MGI Pharma, Inc.
	2/11/1998	5775 West Old Shakopee Rd.
	Suite 100
	Bloomington MN  55437-3107
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polifeprosan 20 with carmustine	Expanding the indication to include patients with malignant glioma 
	undergoing primary surgical resection.
	Trade Name:
	Gliadel	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Guilford Pharmaceuticals, Inc.
	2/25/2003	6611 Tributary Street
	Baltimore  MD  21224 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	polifeprosan 20 with carmustine	As an adjunct to surgery to prolong survival in patients with recurrent 
	glioblastoma multiforme for whom surgical resection is indicated
	Trade Name:
	Gliadel	Orphan Designation:
	Treatment of malignant glioma.
	Designation 
	12/13/1989	Sponsor and Address
	Marketing Exclusivity 	Guilford Pharmaceuticals, Inc.
	9/23/1996	6611 Tributary Street
	Baltimore MD  21224 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	porfimer	For the ablation  of high-grade dysplasia in Barrett's esophagus patients 
	who do not undergo esophagectomy
	Trade Name:
	Photofrin	Orphan Designation:
	For the ablation of High-Grade Dysplasia in Barrett's Esophagus in patients 
	who are not considered to be candidates for esophagectomy
	Designation 
	10/19/2001	Sponsor and Address
	Marketing Exclusivity 	Axcan Scandipharm Inc.
	8/1/2003	22 Inverness Parkway
	Suite 310
	Birmingham AL  35242 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Porfimer sodium	Photodynamic therapy with PHOTOFRIN for the palliation of patients with 
	completely obstructing esophageal cancer, or of patients with partially 
	obstructing esophageal cancer who cannot be satisfactorily treated with 
	Trade Name:	Nd:YAG laser therapy.
	Photofrin	Orphan Designation:
	For the photodynamic therapy of patients with primary or recurrent 
	obstructing (either partially or completely) esophageal carcinoma.
	Designation 
	6/6/1989	Sponsor and Address
	Marketing Exclusivity 	QLT Phototherapeutics, Inc.
	12/27/1995	Lederle Laboratories
	401 North Middletown Road
	Pearl River NY  10965 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	For avoidance of the complication of calcium stone formation in patients 
	with uric lithiasis.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Blvd
	Dallas TX  75235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	Prevention of calcium renal stones in patients with hypocitraturia.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Blvd
	Dallas TX  75235 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Potassium citrate
	Trade Name:
	Urocit-K	Orphan Designation:
	Prevention of uric acid nephrolithiasis.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	University of Texas Health Science Center at Dallas
	8/30/1985	5323 Harry Hines Boulevard
	Dallas TX  75235 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Potassium Iodide Oral Solution 	For use as a thyroid blocking agent in pediatric patients exposed to 
	radiactive iodine 
	Trade Name:
	ThyroShield	Orphan Designation:
	For use as a thyroid blocking agent in pediatric patients exposed to 
	radiactive iodine
	Designation 
	11/17/2004	Sponsor and Address
	Marketing Exclusivity 	Fleming & Company, Pharmaceuticals
	1/1/9999	1733 Gilsinn Lane
	Fenton MO  63026 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Protein C concentrate	Prevention and treatment of venous thrombosis and purpura fulminans
	Trade Name:
	Ceprotin	Orphan Designation:
	For replacement therapy in congenital protein C deficiency for the 
	prevention and treatment of thrombosis, pulmonary emboli, and purpura 
	Designation 	fulminans.
	6/23/1992	Sponsor and Address
	Marketing Exclusivity 	Baxter Healthcare Corporation
	3/30/2007	One Baxter Way
	West Lake Village CA  91362 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Pulmonary surfactant replacement, porcine	Treatment (rescue) of respiratory distress syndrome in premature infants.
	Trade Name:
	Curosurf	Orphan Designation:
	For the treatment and prevention of respiratory distress syndrome in 
	premature infants.
	Designation 
	8/2/1993	Sponsor and Address
	Marketing Exclusivity 	Dey Laboratories
	1/1/9999	2751 Napa Valley Corporate Drive
	Napa CA  94558 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	quinine Sulfate	Treatment of uncomplicated Plasmodium falciparum malaria
	Trade Name:
	Orphan Designation:
	Treatment of malaria 
	Designation 
	6/3/2004	Sponsor and Address
	Marketing Exclusivity 	AR Holding Company, Inc.
	8/12/2005	1100 Orthodox Street
	Philadelphia PA  19124 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Raloxifene 	Reduction in risk of invasive breast cancer in postmenopausal women with 
	osteoporosis and reduction in risk of invasive breast cancer in 
	postmenopausal women at high risk for invasive breast cancer
	Trade Name:
	Evista	Orphan Designation:
	Reduction of the risk of breast cancer in  postmenopausal women
	Designation 
	7/14/2005	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	9/13/2007	Lilly Corporate Center
	Drop Code 1853
	Indianapolis IN  46285 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	rasburicase	Initial management of plasma uric acid levels in pediatric patients with 
	leukemia,lymphoma, and solid tumor malignancies who are receiving anti-
	cancer therapy expected to result in tumor lysis and subsequent elevation of
	Trade Name:	 plasma uric acid.
	Elitek	Orphan Designation:
	Treatment of malignancy-associated or chemotherapy-induced 
	hyperuricemia.
	Designation 
	10/11/2000	Sponsor and Address
	Marketing Exclusivity 	Sanofi-Synthelabo Research
	7/12/2002	9 Great Valley Parkway
	Malvern PA  19355 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human acid alpha-glucosidase	For use in patients with Pompe disease (GAA deficiency).  Alglucosidase 
	alfa has been shown to improve ventilator-free survival in patients with 
	infantile onset Pompe disease as compared to an untreated historical 
	Trade Name:	control, whereas use of Alphaglucosidase in patients with other forms of 
	Pompe disease has not been adequately studied to assure safety and 
	Myozyme	Orphan Designation:
	Treatment of glycogen storage disease type II.
	Designation 
	8/19/1997	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	4/28/2006	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Recombinant human luteinizing hormone	Luveris (lutropin alfa for injection), concomitantly administered with Gonal-f
	 (follitropin alfa for injection), is indicated for stimulation of follicular 
	development in infertile hypogonadotropic hypogonadal women with 
	Trade Name:	profound LH deficiency (LH (less than) 1.2 IU/L).
	Luveris	Orphan Designation:
	For use in association with recombinant human follicle stimulating 
	hormone for the treatment of women with chronic anovulation due to 
	Designation 	hypogonadotropic hypogonadism.
	10/7/1994	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	10/8/2004	One Technology Place
	Rockland  MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Respiratory syncytial virus immune globulin (Human)	For the prevention of serious lower respiratory tract infections caused by 
	RSV in children less than 24 months of age with bronchopulmonary 
	dysplasia or a history of prematurity (less than or equal to 35 weeks 
	Trade Name:	gestation).
	Respigam	Orphan Designation:
	Prophylaxis of respiratory syncytial virus lower respiratory tract infections in 
	infants and young children at high risk of RSV disease.
	Designation 
	9/27/1990	Sponsor and Address
	Marketing Exclusivity 	MedImmune & Massachussetts Public Health Biologics Labs.
	1/18/1996	35 West Watkins Mill Road
	Gaithersburg MD  20878 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rho (D) immune globulin intravenous (human)	Treatment of adults and children with chronic and acute immune 
	thrombocytopenic purpura.
	Trade Name:
	WinRho SD	Orphan Designation:
	Treatment of immune thrombocytopenic purpura.
	Designation 
	11/9/1993	Sponsor and Address
	Marketing Exclusivity 	Rh Pharmaceuticals, Inc.
	3/24/1995	104 Chancellor Matheson Road
	Winnipeg, Manitoba
	    
	CANADA
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	ribavirin	Treatment of chronic hepatitis C among previously untreated pediatric 
	patients at least three years of age or older.
	Trade Name:
	REBETOL	Orphan Designation:
	Treatment of chronic hepatitis C in pediatric patients
	Designation 
	4/4/2003	Sponsor and Address
	Marketing Exclusivity 	Schering Corporation
	7/29/2003	2000 Galloping Hill Road
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifabutin	Prevention of disseminated Mycobacterium avium complex disease in 
	patients with advanced HIV infections.
	Trade Name:
	Mycobutin	Orphan Designation:
	Prevention of disseminated Mycobacterium avium complex disease in 
	patients with advanced HIV infection.
	Designation 
	12/18/1989	Sponsor and Address
	Marketing Exclusivity 	Adria Laboratories, Inc.
	12/23/1992	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifampin
	Trade Name:
	Rifadin I.V.	Orphan Designation:
	For antituberculosis treatment where use of the oral form of the drug is not 
	feasible.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	5/25/1989	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifampin, isoniazid, pyrazinamide	Short-course treatment of tuberculosis.
	Trade Name:
	Rifater	Orphan Designation:
	For the short-course treatment of tuberculosis.
	Designation 
	9/12/1985	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	5/31/1994	P.O. Box 9627
	Kansas City MO  64134 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Rifapentine
	Trade Name:
	Priftin	Orphan Designation:
	Treatment of pulmonary tuberculosis.
	Designation 
	6/9/1995	Sponsor and Address
	Marketing Exclusivity 	Hoechst Marion Roussel
	6/22/1998	P.O. Box 9627
	Mail Station:  H3-M2516
	Kansas City MO  64134-0627
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Rilonacept 	Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
	Trade Name:
	Arcalyst	Orphan Designation:
	Treatment of CIAS1-Associated Periodic Syndromes
	Designation 
	12/20/2004	Sponsor and Address
	Marketing Exclusivity 	Regeneron Pharmaceuticals, Inc.
	2/27/2008	777 Old Saw Mill River Road
	Tarrytown NY  10591 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Riluzole	Treatment of patients with amyotrophic lateral sclerosis.  Riluzole extends 
	survival and/or time to tracheostomy.
	Trade Name:
	Rilutek	Orphan Designation:
	Treatment of amyotrophic lateral sclerosis.
	Designation 
	3/16/1993	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals, Inc.
	12/12/1995	500 Arcola Road, P.O. Box 1200
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	rituximab
	Trade Name:
	Rituxan	Orphan Designation:
	Treatment of non-Hodgkin's B-cell lymphoma.
	Designation 
	6/13/1994	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	11/26/1997	1 DNA Way, MS 242
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sacrosidase	Oral replacement therapy of the genetically determined sucrase deficiency,
	 which is part of congenital sucrease-isomaltase deficiency.
	Trade Name:
	Sucraid	Orphan Designation:
	Treatment of congenital sucrase-isomaltase deficiency.
	Designation 
	12/10/1993	Sponsor and Address
	Marketing Exclusivity 	QOL Medical, LLC
	4/9/1998	12419 198th Drive, NE
	Woodinville WA  98072 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	sapropterin	Indicated to reduce blood phenylalanine (Phe) levels in patients with 
	hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive
	 Phenylketonuria (PKU).  Kuvan is to be used in conjunction with a Phe-
	Trade Name:	restricted diet.
	Kuvan	Orphan Designation:
	Treatment of hyperphenylalaninemia
	Designation 
	1/29/2004	Sponsor and Address
	Marketing Exclusivity 	Biomarin Pharmaceutical Inc.
	12/13/2007	371 Bel Marin Blvd.
	Novato CA  94949 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sargramostim
	Trade Name:
	Leukine	Orphan Designation:
	Treatment of neutropenia associated with bone marrow transplant, for the 
	treatment of graft failure and delay of engraftment, and for the promotion 
	Designation 	of early engraftment.
	5/3/1990	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	3/5/1991	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sargramostim	Following induction chemotherapy in older adult patients with acute 
	myelogenous leukemia to shorten time to neutrophil recovery and to reduce
	 the incidence of severe and life-threatening infections and infections 
	Trade Name:	resulting in death.
	Leukine	Orphan Designation:
	To reduce neutropenia and leukopenia and decrease the incidence of 
	death due to infection in patients with acute myelogenous leukemia.
	Designation 
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	Immunex Corporation
	9/15/1995	51 University Street
	Seattle WA  98101 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Satumomab pendetide	For determining the extent and location of extraphepatic malignant disease
	 in patients with known colorectal and ovarian cancer.
	Trade Name:
	Oncoscint CR/OV	Orphan Designation:
	Detection of ovarian carcinoma.
	Designation 
	9/25/1989	Sponsor and Address
	Marketing Exclusivity 	Cytogen Corporation
	12/29/1992	600 College Road East
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Selegiline HCl
	Trade Name:
	Eldepryl	Orphan Designation:
	As an adjuvant to levodopa and carbidopa treatment of idiopathic 
	Parkinson's disease (paralysis agitans), postencephalitic Parkinsonism, and 
	Designation 	symptomatic Parkinsonism.
	11/7/1984	Sponsor and Address
	Marketing Exclusivity 	Somerset Pharmaceuticals, Inc.
	6/5/1989	777 South Harbor Island Boulevard
	Tampa FL  33602 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sermorelin acetate
	Trade Name:
	Geref	Orphan Designation:
	Treatment of idiopathic or organic growth hormone deficiency in children 
	with growth failure.
	Designation 
	9/14/1988	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	9/26/1997	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	sodium phenylbutyrate	Adjunctive therapy in the chronic managment of patients with urea cycle 
	disorders involving deficiencies of carbamylphosphate synthetase, ornithine
	 transcarbamylase, or argininosuccinic acid synthetase.
	Trade Name:
	Buphenyl	Orphan Designation:
	Treatment of urea cycle disorders: carbamylphosphate synthetase 
	deficiency, ornithine transcarbamylase deficiency, and arginiosuccinic acid 
	Designation 	synthetase deficiency.
	11/22/1993	Sponsor and Address
	Marketing Exclusivity 	Medicis Pharmaceutical Corp.
	4/30/1996	8125 N. Hayden Road
	Scottsdale AZ  85258 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatrem for injection
	Trade Name:
	Protropin	Orphan Designation:
	For long-term treatment of children who have growth failure due to a lack of
	 adequate endogenous growth hormone secretion.
	Designation 
	12/9/1985	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	10/17/1985	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin	Treatment of short stature in patients with Noonan syndrome
	Trade Name:
	Norditropin	Orphan Designation:
	Treatment of short stature in patients with Noonan syndrome
	Designation 
	8/9/2006	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Inc.
	5/31/2007	100 College Road West
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin	Treatment of short stature associated with Turner syndrome in patients 
	whose epiphyses are not closed.
	Trade Name:
	Humatrope	Orphan Designation:
	Treatment of short stature associated with Turner syndrome.
	Designation 
	5/8/1990	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	12/30/1996	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of adults with growth hormone deficiency.
	Designation 
	9/6/1994	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	10/31/1997	7000 Portage Road
	Kalamazoo MI  49001-0199
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin
	Trade Name:
	Nutropin	Orphan Designation:
	For use in the long-term treatment of children who have growth failure due 
	to a lack of adequate endogenous growth hormone secretion.
	Designation 
	3/6/1987	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	10/17/1985	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin)	Long term treatment of children with growth failure due to inadequate 
	secretion of endogenous growth hormone.  
	Trade Name:
	Saizen	Orphan Designation:
	Treatment of idiopathic or organic growth hormone deficiency in children 
	with growth failure.
	Designation 
	3/6/1987	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	1/1/9999	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin)	Long-term treatment of growth failure due to a lack of adequate 
	endogenous growth hormone secetion for once- or twice-a-month 
	administration.
	Trade Name:
	Nutropin Depot	Orphan Designation:
	Long-term treatment of children who have growth failure due to a lack of 
	adequate endogenous growth hormone secretion.  
	Designation 
	10/28/1999	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	1/1/9999	1 DNA Way
	South San Francisco CA  94080-4990
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (rDNA origin) injection	Long-term treatment of children who have growth failure due to inadequate
	 secretion of endogenous growth hormone.
	Trade Name:
	Norditropin	Orphan Designation:
	Treatment of growth failure in children due to inadequate growth hormone 
	secretion.
	Designation 
	7/10/1987	Sponsor and Address
	Marketing Exclusivity 	Novo Nordisk Pharmaceuticals
	1/1/9999	100 Overlook Center
	Suite 200
	Princeton NJ  08540 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin (r-DNA)	Treatment of short bowel syndrome in patients receiving specialized 
	nutritional support
	Trade Name:
	Zorbtive	Orphan Designation:
	For use alone or in combination with glutamine in the treatment of short 
	bowel syndrome.
	Designation 
	3/6/1995	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	12/1/2003	One Technology Place
	Roackland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin [rDNA]	Long-term treatment of pediatric patients who have growth failure due to 
	Prader-Willi syndrome (PWS).
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of short stature in patients with Prader-Willi syndrome.
	Designation 
	7/6/1999	Sponsor and Address
	Marketing Exclusivity 	Pharmacia & Upjohn
	6/20/2000	7000 Portage Rd.
	0633-298-113
	Kalamazoo MI  49001-0199
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	somatropin [rDNA]	For long-term treatment of growth failure in children born small for 
	gestational age who fail to manifest catch-up growth by two years of age.
	Trade Name:
	Genotropin	Orphan Designation:
	Treatment of growth failure in children who were born small for gestational 
	age.
	Designation 
	12/27/2000	Sponsor and Address
	Marketing Exclusivity 	Pharmacia and Upjohn Company
	7/25/2001	7000 Portage Road
	Kalamazoo MI  49001 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection
	Trade Name:
	Humatrope	Orphan Designation:
	For the long-term treatment of children who have growth failure due to 
	inadequate secretion of normal endogenous growth hormone.
	Designation 
	6/12/1986	Sponsor and Address
	Marketing Exclusivity 	Eli Lilly and Company
	3/8/1987	Lilly Corporate Center
	Indianapolis IN  46285 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection
	Trade Name:
	Nutropin	Orphan Designation:
	As replacement therapy for growth hormone deficiency in adults after 
	epiphyseal closure.
	Designation 
	11/18/1996	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/15/1997	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of children with growth failure associated with chronic renal 
	insufficency.
	Trade Name:
	Nutropin	Orphan Designation:
	Treatment of growth retardation associated with chronic renal failure.
	Designation 
	8/4/1989	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	11/17/1993	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of AIDS wasting or cachexia.
	Trade Name:
	Serostim	Orphan Designation:
	Treatment of AIDS-associated catabolism/weight loss.
	Designation 
	11/15/1991	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	8/23/1996	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Somatropin for injection	Treatment of growth failure associated with Turner syndrome.
	Trade Name:
	Nutropin	Orphan Designation:
	Treatment of short stature associated with Turner's syndrome.
	Designation 
	3/23/1989	Sponsor and Address
	Marketing Exclusivity 	Genentech, Inc.
	12/30/1996	460 Point San Bruno Boulevard
	South San Francisco CA  94080 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorafenib	Treatment of unresectable hepatocellular carcinoma
	Trade Name:
	Nexavar	Orphan Designation:
	Treatment of hepatocellular carcinoma
	Designation 
	4/20/2006	Sponsor and Address
	Marketing Exclusivity 	Bayer Pharmaceuticals Corporation
	3/24/2008	400 Morgan Lane
	West Haven CT  06516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sorafenib	Treatment of patients with advanced renal cell carcinoma
	Trade Name:
	Nexavar	Orphan Designation:
	Treatment of renal cell carcinoma.
	Designation 
	10/8/2004	Sponsor and Address
	Marketing Exclusivity 	Bayer Pharmaceutical Corporation
	12/20/2005	400 Morgan Lane
	West Haven CT  06516 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sotalol HCl
	Trade Name:
	Betapace	Orphan Designation:
	Treatment of life-threatening ventricular tachyarrhythmias.
	Designation 
	9/23/1988	Sponsor and Address
	Marketing Exclusivity 	Berlex Laboratories, Inc.
	10/30/1992	300 Fairfield Road
	Wayne NJ  07470 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Sterile talc powder	Prevention of recurrence of malignant pleural effusions in symptomatic 
	patients.
	Trade Name:
	Sclerosol Intrapleural Aerosol	Orphan Designation:
	Treatment of malignant pleural effusion.
	Designation 
	9/18/1995	Sponsor and Address
	Marketing Exclusivity 	Bryan Corporation
	12/24/1997	4 Plympton Street
	Woburn MA  01801 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Succimer
	Trade Name:
	Chemet capsules	Orphan Designation:
	Treatment of lead poisoning in children.
	Designation 
	5/9/1984	Sponsor and Address
	Marketing Exclusivity 	Bock Pharmacal Company
	12/22/1988	P.O. Box 419056
	Saint Louis MO  63141-9056
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Sulfadiazine	Toxoplasmosis, as adjunctive with pyrimethamine
	Trade Name:
	Orphan Designation:
	For use in combination with pyrimethamine for the treatment of 
	Toxoplasma gondii
	Designation 	encephalitis in patients with and without AIDS.
	3/14/1994	Sponsor and Address
	Marketing Exclusivity 	Eon Labs Manufacturing, Inc.
	7/29/1994	227-15 North Conduit Avenue
	Laurelton NY  11413 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Surface active extract of saline lavage of bovine lungs	Treatment and prevention of respiratory failure due to pulmonary surfactant
	 deficiency in preterm infants.
	Trade Name:
	Infasurf	Orphan Designation:
	Treatment and prevention of respiratory failure due to pulmonary surfactant
	 deficiency in preterm infants.
	Designation 
	6/7/1985	Sponsor and Address
	Marketing Exclusivity 	ONY, Inc.
	1/1/9999	1576 Sweet Home Road
	Amherst NY  14228 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	For use in secretin stimulation testing for: Stimulation of pancreatic 
	secretions to facilitate the identification of the ampulla of Vater and 
	accessory papilla during endoscopic retrograde cholangio-pancreatography 
	Trade Name:	(ERCP)
	Orphan Designation:
	For use in the evaluation of exocrine pancreas function.
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	11/1/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	Use in secretin stimulation testing for stimulation of pancreatic secretions, 
	including bicarbonate, to aid in the diagnosis of pancreatic exocrine 
	dysfunction
	Trade Name:
	Orphan Designation:
	For use in conjunction with diagnostic procedures for pancreatic disorders to
	 increase pancreatic fluid secretion.  
	Designation 
	3/7/2000	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	4/4/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Synthetic porcine secretin	Use in secretin stimulation testing for stimulation of gastrin secretion to aid 
	in the diagnosis of gastrinoma
	Trade Name:
	Orphan Designation:
	For use in the diagnosis of gastrinoma associated with Zollinger-Ellison 
	syndrome.  
	Designation 
	6/18/1999	Sponsor and Address
	Marketing Exclusivity 	ChiRhoClin, Inc.
	4/4/2002	15500 Gallaudet Ave.
	Silver Spring MD  20905-4176
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tacrolimus	Prophylaxis of organ rejection in patients receiving allogenic heart 
	transplants. 
	Trade Name:
	Prograf	Orphan Designation:
	Prophylaxis of organ rejection in patients receiving heart transplants.
	Designation 
	6/6/2005	Sponsor and Address
	Marketing Exclusivity 	Astellas Pharma US, Inc.
	3/29/2006	Three Parkway North
	Deerfield IL  60015-2548
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	temozolomide	Treatment of adult patients with newly diagnosed glioblastoma multiforme 
	concomitatly with radiotherapy and then as maintenance treatment
	Trade Name:
	Temodar	Orphan Designation:
	Treatment of malignant glioma
	Designation 
	10/5/1998	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Reasearch Institute
	3/15/2005	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Temozolomide	Treatment of adult patients with refractory anaplastic astrocytoma, i.e., 
	patients at first relapse who have experienced disease progression on a 
	drug regimen containing a nitrosourea and procarbazine.
	Trade Name:
	Temodar	Orphan Designation:
	Treatment of recurrent malignant glioma.  
	Designation 
	10/5/1998	Sponsor and Address
	Marketing Exclusivity 	Schering-Plough Research Institute
	8/11/1999	2000 Galloping Hill Rd.
	Kenilworth NJ  07033 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Temsirolimus	Treatment of advanced renal cell carcinoma
	Trade Name:
	Torisel	Orphan Designation:
	Treatment of renal cell carcinoma
	Designation 
	12/16/2004	Sponsor and Address
	Marketing Exclusivity 	Wyeth Pharmaceuticals, Inc.
	5/30/2007	P. O. Box 8299
	Phildelphia PA  19101-8299
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Teniposide	Induction therapy in patients with refractory childhood acute lymphoblastic 
	leukemia when used in combination with other approved anticancer agents.
	Trade Name:
	Vumon for injection	Orphan Designation:
	Treatment of refractory childhood acute lymphocytic leukemia.
	Designation 
	11/1/1984	Sponsor and Address
	Marketing Exclusivity 	Bristol-Myers Squibb Pharmaceutical Research Institute
	7/14/1992	5 Research Parkway
	P.O. Box 5100
	Wallingford CT  06492 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Teriparatide
	Trade Name:
	Parathar	Orphan Designation:
	Diagnostic agent to assist in establishing the diagnosis in patients 
	presenting with clinical and laboratory evidence of hypocalcemia due to 
	Designation 	either hypoparathyroidism or pseudohypoparathyroidism.
	1/9/1987	Sponsor and Address
	Marketing Exclusivity 	Rhone-Poulenc Rorer Pharmaceuticals, Inc.
	12/23/1987	500 Arcola Road
	Collegeville PA  19426 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide	Acute treatment of the cutaneous manifestations of moderate to severe 
	erythema nodosum leprosum (ENL) and as maintenance therapy for 
	prevention and suppression of the cutaneous manifestations of ENL 
	Trade Name:	recurrences.
	Thalomid	Orphan Designation:
	Treatment of erythema nodosum leprosum.
	Designation 
	7/26/1995	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	7/16/1998	86 Morris Avenue
	Summit NJ  07901 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thalidomide	Treatment of patients with newly diagnosed multiple myeloma
	Trade Name:
	Thalomid	Orphan Designation:
	Treatment of multiple myeloma
	Designation 
	10/14/1998	Sponsor and Address
	Marketing Exclusivity 	Celgene Corporation
	5/25/2006	7 Powder Horn Dr.
	Warren NJ  07059 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Thyrotropin alfa	For use as an adjunctive treatment for radioiodine ablation of thyroid tissue 
	remnants in patients who have undergone thyroidectomy for well-
	differentiated thyroid cancer and who do not have evidence of metastatic 
	Trade Name:	thyroid cancer
	Thyrogen	Orphan Designation:
	Treatment of well-differentiated papillary, follicular or combined 
	papillary/follicular carcinomas of the thyroid
	Designation 
	8/3/2001	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	12/14/2007	One Kendall Square
	Cambridge MA  02139-1562
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Thyrotropin alpha	As an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or 
	without radioiodine imaging in the follow-up of patients with thyroid cancer.
	Trade Name:
	Thyrogen	Orphan Designation:
	As an adjunct in the diagnosis of thyroid cancer.
	Designation 
	2/24/1992	Sponsor and Address
	Marketing Exclusivity 	Genzyme Corporation
	11/30/1998	One Kendall Square
	Cambridge MA  02139 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	tinidazole	Treatment of giardiasis caused by G. duodenalis (also termed G. lamblia) 
	in both adults and pediatric patients older than three years of age
	Trade Name:
	Tindamax	Orphan Designation:
	Treatment of giardiasis
	Designation 
	4/18/2002	Sponsor and Address
	Marketing Exclusivity 	Presutti Laboratories, Inc.
	5/17/2004	1607 N. Douglas Ave.
	Arlington Heights IL  60004 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tinidazole	Treatment of intestinal amebiasis and amebic liver abcess caused by E. 
	histolytica in both adults and pediatric patients older than three years of 
	age.  It is not indicated for the treatment of asymptomatic cyst passage.
	Trade Name:
	Tindamax	Orphan Designation:
	Treatment of amebiasis
	Designation 
	8/20/2003	Sponsor and Address
	Marketing Exclusivity 	Presutti Laboratories, Inc.
	5/17/2004	1607 N. Douglas Avenue
	Arlington Heights IL  60004 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tiopronin
	Trade Name:
	Thiola	Orphan Designation:
	Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.
	Designation 
	1/17/1986	Sponsor and Address
	Marketing Exclusivity 	Pak, Charles Y.C. M.D.
	8/11/1988	The University of Texas Health Scienc Center at Da
	5323 Harry Hines Boulevard
	Dallas TX  75235 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Tobramycin for inhalation	Management of cystic fibrosis patients with P.aeruginosa.
	Trade Name:
	TOBI	Orphan Designation:
	Treatment of bronchopulmonary infections of Pseudomonas aeruginosa in 
	cystic fibrosis patients.
	Designation 
	10/13/1994	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp
	12/22/1997	Drug Regulatory Affairs
	One Health Plaza
	East Hanover NJ  07936-1080
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Topiramate	As adjunctive therapy in patients two years and older with siezures 
	associated with Lennox-Gastaut syndrome.
	Trade Name:
	Topamax	Orphan Designation:
	Treatment of Lennox-Gastaut syndrome.
	Designation 
	11/25/1992	Sponsor and Address
	Marketing Exclusivity 	Johnson & Johnson Pharmaceutical R & D, LLC
	8/28/2001	Route 202, P.O. Box 300
	Raritan NJ  08869-0602
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Toremifene	Treatment of metastatic breast cancer in postmenopausal women with 
	estrogen positive or receptor unknown tumors.
	Trade Name:
	Fareston	Orphan Designation:
	Hormonal therapy of metastatic carcinoma of the breast.
	Designation 
	9/19/1991	Sponsor and Address
	Marketing Exclusivity 	Orion Corporation
	5/29/1997	P.O. Box 65
	02101 ESPOO
	    
	FINLAND
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tositumomab and iodine I 131 tositumomab	Treatment of patients with CD20 positive, follicular, non-Hodgkin's 
	lymphoma, with and without transformation, whose disease is refractory to 
	Rituximab and has relapsed following chemotherapy
	Trade Name:
	Bexxar	Orphan Designation:
	Treatment of non-Hodgkin's B-cell lymphoma.
	Designation 
	5/16/1994	Sponsor and Address
	Marketing Exclusivity 	GlaxoSmithKline
	6/27/2003	2301 Renaissance Blv.
	P.O. Box 61540
	King of Prussia PA  19406-2772
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tranexamic acid
	Trade Name:
	Cyklokapron	Orphan Designation:
	Treatment of patients with congenital coagulopathies who are undergoing 
	surgical procedures (e.g. dental extractions).
	Designation 
	10/29/1985	Sponsor and Address
	Marketing Exclusivity 	Pharmacia Inc.
	12/30/1986	P.O. Box 16529
	Columbus OH  43216 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	treprostinil	Treatment of pulmonary arterial hypertension.
	Trade Name:
	Remodulin	Orphan Designation:
	Treatment of pulmonary arterial hypertension.
	Designation 
	6/4/1997	Sponsor and Address
	Marketing Exclusivity 	United Therapeutics Corp.
	5/21/2002	68 T.W. Alexander Dr.
	P.O. Box 14186
	Research Triangle Park NC  27709 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Tretinoin	Induction of remission in patients with acute promyelocytic leukemia who 
	are refractory to or unable to tolerate anthracycline based cytotoxic 
	chemotherapeutic regimens.
	Trade Name:
	Vesanoid	Orphan Designation:
	Treatment of acute promyelocytic leukemia.
	Designation 
	10/24/1990	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	11/22/1995	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trientine HCl
	Trade Name:
	Syprine	Orphan Designation:
	Treatment of patients with Wilson's disease who are intolerant, or 
	inadequately responsive to penicillamine.
	Designation 
	12/24/1984	Sponsor and Address
	Marketing Exclusivity 	Merck Sharp & Dohme Research
	11/8/1985	Division Of Merck And Company
	West Point PA  19486 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Trimetrexate glucuronate	Concurrent leucovorin administration as an alternative therapy for the 
	treatment of moderate to severe PCP in immunocompromised patients who
	 are intolerant of, or are refractory to, trimethoprim sulfamethoxazole.
	Trade Name:
	Neutrexin	Orphan Designation:
	Treatment of Pneumocystis carinii pneumonia in AIDS patients.
	Designation 
	5/15/1986	Sponsor and Address
	Marketing Exclusivity 	Medimmune Oncology, Inc.
	12/17/1993	One Tower Bridge
	100 Front Street, Suite 400
	West Conshohocken PA  19428 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Urofollitropin
	Trade Name:
	Metrodin	Orphan Designation:
	For induction of ovulation in patients with polycystic ovarian disease who 
	have an elevated LH/FSH ratio and who have failed to respond to 
	Designation 	adequate clomiphene citrate therapy.
	11/25/1987	Sponsor and Address
	Marketing Exclusivity 	EMD Serono, Inc.
	9/18/1986	One Technology Place
	Rockland MA  02370 
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Ursodiol
	Trade Name:
	URSO	Orphan Designation:
	Treatment of patients with primary biliary cirrhosis.
	Designation 
	6/20/1991	Sponsor and Address
	Marketing Exclusivity 	Axcan Pharma Inc.
	12/10/1997	597 Laurier Blvd
	Mount St. Hilaire Quebec  H7L 4S3
	    
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vaccinia Immune Globulin (Human) Intravenous	treatment and/or modification of the following conditions, which are 
	complications resulting from smallpox vaccination: Eczema vaccinatum 
	Progressive vaccinia Severe generalized vaccinia Vaccinia infections in 
	Trade Name:	individuals who have skin conditions such as burns, impetigo, varicella-
	zoster, or poison ivy; or in individuals who have eczematous skin lesions 
	because of either the activity or extensiveness of such lesions Aberrant 
	infections induced by vaccinia virus that include its accidental implantation
	 in eyes (except in cases of isolated keratitis), mouth, or other areas where 
	CNJ-016	Orphan Designation:
	Treatment of complications of vaccinia vaccination
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	Cangene Corporation
	1/1/9999	104 Chancellor Matheson Road
	Winnipeg, ManitobaR3T 5Y3    
	 
	CANADA
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Vaccinia Immune Globulin (Human) Intravenous	Treatment and modification of aberrant infections induced by vaccinia virus
	 that include its accidental implantation in eyes (except in cases of isolated 
	keratitis), mouth, or other areas where vaccinia infection would constitute a 
	Trade Name:	special hazard; eczema vaccinatum; progressive vaccinia; severe 
	generalized vaccinia, and vaccinia infections in individuals who have skin 
	conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in 
	individuals who have eczematous skin lesions because of either the activity 
	Orphan Designation:
	Treatment of severe complications from the smallpox vaccine
	Designation 
	6/18/2004	Sponsor and Address
	Marketing Exclusivity 	DynPort Vaccine Company LLC
	2/18/2005	64 Thomas Johnson Drive
	Frederick MD  21702 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Valrubicin	For intravesical therapy of BCG-refractory carcinoma in situ of the urinary 
	bladder in patients for whom immediate cystectomy would be associated 
	with unacceptable morbidity or mortality.
	Trade Name:
	Valstar	Orphan Designation:
	Treatment of carcinoma in situ of the urinary bladder.
	Designation 
	5/23/1994	Sponsor and Address
	Marketing Exclusivity 	Anthra Pharmaceuticals, Inc.
	9/25/1998	103 Carnegie Center, Suite 102
	Princeton NJ  08540 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	vorinostat	Treatment of cutaneous manifestations in patients with cutaneous T-cell 
	lymphoma (CTCL) who have progressive, persistant or recurrent disease on 
	or following two systemic therapies.
	Trade Name:
	Zolinza	Orphan Designation:
	Treatment of T-cell non-Hodgkin's lymphoma
	Designation 
	3/16/2004	Sponsor and Address
	Marketing Exclusivity 	Merck & Co., Inc.
	10/6/2006	P. O. Box 2000, RY 32-605
	Rahway NJ  07065-0900
	 
	***************************************************************************************

	Generic Name	Approved Orphan Indication:
	Zalcitabine	Combination therapy with zidovudine is indicated for the treatment of adult
	 patients with advanced HIV infection (CD4 count < 300) who have 
	demonstrated malignant clinical or immunologic deterioration.
	Trade Name:
	Hivid	Orphan Designation:
	Treatment of AIDS.
	Designation 
	6/28/1988	Sponsor and Address
	Marketing Exclusivity 	Hoffmann-La Roche, Inc.
	6/19/1992	340 Kingsland Street
	Nutley NJ  07110 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zidovudine
	Trade Name:
	Retrovir	Orphan Designation:
	Treatment of AIDS.
	Designation 
	7/17/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	3/19/1987	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zidovudine
	Trade Name:
	Retrovir	Orphan Designation:
	Treatment of AIDS related complex.
	Designation 
	7/17/1985	Sponsor and Address
	Marketing Exclusivity 	Glaxo Wellcome Inc.
	3/19/1987	5 Moore Drive
	Research Triangle Park NC  27709 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zinc acetate	For maintenance treatment of patients with Wilson's disease who have been
	 initially treated with a chelating agent.
	Trade Name:
	Galzin	Orphan Designation:
	Treatment of Wilson's disease.
	Designation 
	11/6/1985	Sponsor and Address
	Marketing Exclusivity 	Lemmon Company
	1/28/1997	1510 Delp Drive
	Kulpsville PA  19443 
	 
	***************************************************************************************
	Generic Name	Approved Orphan Indication:
	Zoledronate	Treatment of hypercalcemia of malignancy.
	Trade Name:
	Zometa, Zabel	Orphan Designation:
	Treatment of tumor induced hypercalcemia.  
	Designation 
	8/18/2000	Sponsor and Address
	Marketing Exclusivity 	Novartis Pharmaceuticals Corp.
	8/20/2001	59 Route 10
	East Hanover NJ  07936-1080
	 
	***************************************************************************************