HHS License-Based Vaccines & Therapeutics
Active Licenses - Vaccines and Therapeutics Developed with Technologies Licensed from HHS Intramural Research Programs
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Spravato® |
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Spravato (esketamine) is a nasal spray used in conjunction with an oral antidepressant for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). |
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Licensee: |
Janssen Therapeutics |
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FDA Approval: |
March 6, 2019 |
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First Commercial U.S. Sale: |
2019 |
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Agency: |
NIH |
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U.S. Patents: |
8,785,500; 9,539,220; 9,592,207 |
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Lumoxiti™ |
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Lumoxiti is a CD22-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). |
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Licensee: |
AstraZeneca |
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FDA Approval: |
September 13, 2018 |
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First Commercial U.S. Sale: |
2019 |
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Agency: |
NIH |
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U.S. Patents: |
4,892,827; 5,747,654; 5,980,895; 6,074,644; 6,147,203; 6,558,672; 7,355,012; 7,541,034; 7,777,019; 7,982,011; 8,809,502; 9,592,304 |
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Yescarta® |
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A chimeric antigen receptor (CAR) genetically modified autologous T cell immunotherapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. |
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Licensee: |
Kite Pharma |
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FDA Approval: |
October 18, 2017 |
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First Commercial U.S. Sale: |
2018 |
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Agency: |
NIH |
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U.S. Patents: |
7,575,742; 8,298,525; 8,636,997 |
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Ella® |
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A progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. |
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Licensee: |
Laboratoire HRA Pharma |
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FDA Approval: |
March 10, 2015 |
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First Commercial U.S. Sale: |
2016 |
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Agency: |
NIH |
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U.S. Patents: |
9,283,233; 9,616,073; 10,159,681 |
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Kepivance® |
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Kepivance® (palifermin) is a human keratinocyte growth factor protein produced using recombinant DNA technology. It is used to decrease the incidence and duration of severe mouth sores in patients with hematologic cancers who receive myelotoxic therapy. In such a therapy, the patients' myeloid cells are first destroyed by chemotherapy alone or in combination with radiation, and then reconstituted with a bone marrow transplant. Kepivance® is the first and only therapy to treat the severe mouth sores that afflict these patients as a painful and unavoidable side effect of the treatment. |
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Licensee: |
Amgen Inc. |
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FDA Approval: |
December 15, 2004 |
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First Commercial U.S. Sale: |
2005 |
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Agency: |
NIH |
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U.S. Patents: |
5,654,405; 5,665,870; 5,707,805; 5,731,170; 5,741,642; 6,420,531; 6,709,842; 6,833,132; 7,026,291 |
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Velcade® |
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A treatment for multiple myeloma that works by specifically inhibiting an enzyme complex known as the proteosome. Under an accelerated approval program, the FDA has allowed the use of Velcade® in patients who have failed two prior therapies. The selectivity and manageable side-effect profile of this boronic dipeptide compound makes it an exciting new cancer drug. NIH researchers made a critical contribution by developing stable, pharmaceutically acceptable compositions of these important compounds. Indeed, as the first proteosome inhibitor to be approved by the FDA, Velcade® opens the door for a new class of useful drugs. |
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Licensee: |
Millennium Pharmaceuticals |
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FDA Approval: |
May 13, 2003 |
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First Commercial U.S. Sale: |
2003 |
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Agency: |
NIH |
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U.S. Patents: |
6,699,835; 6,713,446; 6,958,319; 7,109,323 |
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Archive of Products Previously Developed Using HHS Technologies |
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