APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS
25th EDITION
Cumulative Supplement 3
Prepared By
Office of Pharmaceutical Science
Office of Generic Drugs
Center for Drug Evaluation and Research, FDA
March 2005

CONTENTS

1.0 INTRODUCTION

1.1 How to Use the Cumulative Supplement
1.2 Applicant Name Changes
1.3 Availability of the Edition
1.4 Report of Counts for the Prescription Drug Product List
1.5 Cumulative Supplement Legend

DRUG PRODUCT LISTS

Prescription Drug Product List
OTC Drug Product List
Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics
Evaluationand Research List
Orphan Drug Product Designations
Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM

A. Patent and Exclusivity Lists

B. Patent and Exclusivity Terms

1.0 INTRODUCTION

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT

This Cumulative Supplement is one of a series of monthly updates to the Approved Drug Products with Therapeutic Equivalence Evaluations, 25th Edition (the List).  The List is composed of four parts:  approved prescription drug products with therapeutic equivalence evaluations; over-the-counter (OTC) drug products that require approved applications as a condition of marketing; drug products with approval under Section 505 of the Act administered by the Center for Biologics Evaluation and Research; and products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons.

The Cumulative Supplement provides, among other things, information on newly approved drugs and, if necessary, revised therapeutic equivalence evaluations and updated patent and exclusivity data. The Addendum contains appropriate drug patent and exclusivity information required of the Agency by the "Drug Price Competition and Patent Term Restoration Act of 1984" for the Prescription, OTC, and Drug Products with Approval under Section 505 of the Act Administered by the Center for Biologics Evaluation and Research Lists.

Because all parts of the publication are subject to changes, additions, or deletions, the List must be used in conjunction with the most current Cumulative Supplement.  Users may wish to mark to the left of the ingredient(s) in the List to indicate that changes to that entry appear in the Cumulative Supplement.  Drug product information is provided in each Cumulative Supplement for completeness to assist in locating the proper place in the List for the revision.

The presence of any therapeutic equivalence code indicates that the drug product is multisource; the deletion of a therapeutic equivalence code indicates that the drug product has become single source.  (An infrequent exception exists when a therapeutic equivalence code is revised.  In that case the deletion of the therapeutic equivalence code is followed immediately by the addition of the revised one.)

Products that have never been marketed, are for exportation, are for military use, or have been discontinued from marketing or that have had their approvals withdrawn for other than safety or efficacy reasons, will be flagged in this Cumulative Supplement with the "@" symbol to designate their non-marketed status.  All products having a "@" symbol in the 12th Cumulative Supplement of the 25th Edition List will then be added to the "Discontinued Drug Product List" appearing in the 26th Edition.  The current edition Section 2. How To Use The Drug Product Lists describes the layout and usage of the List.

New additions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >A>.  The Patent and Exclusivity Data are indicated by the symbol >ADD> to the left of the line on which new information exists.  The >ADD> symbol is then dropped in subsequent Cumulative Supplements for that item.

New deletions to the Prescription Drug Product List and OTC Drug Product List are indicated by the symbol >D> (DELETE) to the left of the line.  The information line with the >D> symbol is dropped in subsequent Cumulative Supplements for that item.

The Patent and Exclusivity Lists are arranged in alphabetical order by active ingredient name.  In addition, the trade name will be displayed to the right of the active ingredient name for each product.  Also shown is the application number and product number (FDA's internal file number) for reference purposes.  All patents with their expiration dates are displayed for each application number.  Drug substance and drug product patents are indicated as such with DS or DP in the Patent codes column.  Use patents are indicated with the symbol "U" followed by a number representing a specific use.  Exclusivity information for a specific drug is indicated by an abbreviation followed by the date upon which the exclusivity expires.  Refer to the Exclusivity Terms, Section B, in the Patent and Exclusivity Information Addendum for an explanation of all codes and abbreviations.  Refer to Section 1.3 for internet access to the most current list of Patent and Exclusivity terms.

 

1.2 APPLICANT NAME CHANGES

It is not practical to identify in the Cumulative Supplement each and every product involved when an applicant transfers its entire line of approved drug products to another applicant, or when an applicant changes its name.  Therefore, the cumulation of these transfers and name changes will be identified in this section only.  Where only partial lines of approved products are transferred between applicants, each approved product involved will appear as an applicant name change entry in the Cumulative Supplement.

It is also not practical to identify each and every product involved when an applicant name is  changed to  meet  internal  publication  standards  (e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively,  to Merck Sharp Dohme  or Zenith  Labs [New Abbreviated Names]).  When this occurs, each product involved (either currently in the Cumulative Supplement or in the following year's edition) will reflect the new abbreviated name.  Consequently, it will not appear as an applicant name change entry in the Cumulative Supplement nor will the cumulation of these name changes appear in this section.  The Electronic Orange Book Query, updated monthly, will contain the most current applicant holder name.

                                                                         

FORMER APPLICANT NAME                 NEW APPLICANT NAME

  (FORMER ABBREVIATED NAME)             (NEW ABBREVIATED NAME)

 

FUJISAWA HEALTHCARE	ASTELLAS PHARMA US INC
( FUJISAWA HLTHCARE)	(ASTELLAS)
SHIRE LABORATORIES INC	SHIRE DEVELOPMENT INC
(SHIRE LABS)	(SHIRE)
SHIRE PHARMACEUTICAL DEVELOPMENT INC	SHIRE DEVELOPMENT INC
(SHIRE PHARM)	(SHIRE)
YAMANOUCHI PHARMA AMERICA INC	ASTELLAS PHARMA US INC
(YAMANOUCHI)	(ASTELLAS)

1.3 AVAILABILITY OF THE EDITION

Commencing with the 25th edition, the Annual Edition and monthly Cumulative Supplements will not be available in a published paper version.  Since 1997, the Electronic Orange Book (EOB http://www.fda.gov/cder/ob/default.htm, has been available on the internet and has become the updated-every-month Orange Book.   

By early April, the 25th edition and current monthly supplement will be available in an electronic downloadable Portable Document Format (PDF) at the EOB home page by clicking on the EOB Preface.  The PDF annual and cumulative supplements will duplicate previous paper versions.  Over time, there will be an archive for the annuals and each year's December Cumulative Supplement.  

The Electronic Orange Book Query (EOB) is at http://www.fda.gov/cder/ob/default.htm.  The Query provides searching of the approved drug list by active ingredient, proprietary name, applicant holder, applicant number or patent number.  Product search categories are: prescription, over-the-counter, discontinued drugs.  There are links to patent and exclusivity information that may be applicable to each product.  Currently, In addition to monthly updates, in the public interest, the EOB is updated on a daily basis with new generic product approval information and new patent information.  Current month updates are accomplished by the third week of the following month.  

The Internet version of the Orange Book annual edition is at

http://www.fda.gov/cder/ob/docs/preface/ectablec.htm   The Internet version of the monthly supplement is at http://www.fda.gov/cder/orange/supplement/cspreface.htm .   

There are historical lists of Orange Book cumulative supplement product  monthly changes at http://www.fda.gov/cder/rxotcdpl/pdplarchive.htm  

There are ASCII text files of the Orange Book drug product, patent, and exclusivity data at http://www.fda.gov/cder/orange/obreadme.htm .  The drug product text files are zipped into eobzip.exe.  The files are updated concurrently with the monthly cumulative supplements.  Appendix A and Appendix B text files of the annual Orange Book Edition are updated quarterly.   

The 25th annual edition of the 2005 Orange Book Patent and Exclusivity List is at http://www.fda.gov/cder/orange/24bookpub.pdf. 

The current year Patent and Exclusivity cumulative supplement list that denotes the current month additions is at http://www.fda.gov/cder/orange/supplement/patents.pdf.  

Effective August 18, 2003 , patent submissions for publication in the Orange Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may be downloaded from the FDA Forms List, http://www.fda.gov/opacom/morechoices/fdaforms/default.html.    

The current listing of the Orphan Product Designations and Approvals is available at http://www.fda.gov/orphan/designat/list.htm.

 

1.4 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

DESCRIPTION OF REPORT

This report provides summary counts derived from the product information in the Prescription Drug Product List and the current Cumulative Supplement.  Products included in the counts are domestically marketed drug products approved for both safety and effectiveness under section 505 of the Federal Food, Drug, and Cosmetic Act.  Excluded are approved drug products marketed by distributors; those marketed solely abroad; and those now regarded as medical devices, biologics or foods.

The baseline column (Dec 2004) refers to the products in the Prescription Drug Product List. For each three-month period, a column of quarterly data is added which incorporates counts of product activity from the previous quarter(s) with those in the baseline count.

DEFINITIONS

For this report, a drug product is the representation in the Prescription Drug Product List of an active moiety (molecular entity and its salts, esters and derivatives) either as a single ingredient or as a combination product provided in a specific dosage form and strength for a given route of administration with approval for marketing by a firm under a particular generic or trade name.  

New Molecular Entity  

A new molecular entity is considered an active moiety that has not previously been approved (either as the parent compound or as a salt, ester or derivative of the parent compound) in the United States for use in a drug product either as a single ingredient or as part of a combination.

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST

COUNTS CUMULATIVE BY QUARTER

¹ >Amino acid‑containing products of varying composition (see Introduction, page xx of the List).

1.5 CUMULATIVE SUPPLEMENT LEGEND

The List is sorted by Ingredient(s) and, within each grouping, by the Dosage Form; Route and then by trade name.  

The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date.  The last two columns describe the action.  The Action Month is the CS month the action occurred.  The OB Action is the type of change that has occurred.  

New ingredient(s), new dosage form; route(s), new trade names, and new product additions are preceded by >A> during the action month.   The change month is the current CS month; the change code for new approvals is NEWA.  Following months will display the same information without the >A>.  

Changes to currently listed products will list two records.  The deleted product record will be proceeded by >D>.  The product record change addition being made will be preceded by >A>.  Following months will display only the >A> record without the >A>.  All changes that occur to the product through the Annual year will be listed.  The change month and change code will document the change.  

The change code and description:

        NEWA      New drug product approval usually in the supplement month.

        CAHN      Applicant holder firm name has changed.

     CAIN      Change. There has been a change in the Ingredient(s) name. All products will be deleted under the old name and all products will be added under the changed ingredient(s) name.

        CDFR      Change.  Dosage Form; Route of Administration.

        CFTG      Change.  A first time generic for the innovator product.  A TE Code is added.

        CMFD      Change.  The product is moved from the Discontinued Section due to a change in marketing status.

        CMS1      Change. Miscellaneous addition to list.

        CMS2      Change. Miscellaneous deletion from list.

        CPOT      Change. Potency amount/unit.

        CRLD      Change. Reference Listed Drug.

        CTEC      Change. Therapeutic Equivalence Code.

        CTNA      Change. Trade Name.

        DISC      Discontinued.  The Rx or OTC listed product is not being marketed and will be moved to the discontinued section in the next edition.

        WDAG      Withdrawn.  The applicant holder has notified the FDA in writing that the product in no longer being marketed resulting in the product approval being withdrawn by mutual agreement.  The product will be listed in the Discontinued Section.

        WDRP      Withdrawn. The application approval has been withdrawn for failure to provide Annual Reports.  The product will be moved to the Discontinued Section in the next edition.

 

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST CUMULATIVE SUPPLEMENT

NO MARCH 2005 APPROVALS

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION

NO MARCH 2005 ADDITIONS

PATENT AND EXCLUSIVITY TERMS

Please refer to this page for an explanation of the patent and exclusivity abbreviations found in the Orange Book.

• Patent Use Codes
• Exclusivity Codes

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Last update:  April 22, 2005

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