HHS License-Based Vaccines & Therapeutics
Active Licenses
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View the Other Products Previously Developed Using HHS Technologies
| Product Name | Description | Licensee | FDA Approval | First Commercial U.S. Sale | Agency | U.S. Patents |
|---|---|---|---|---|---|---|
Vimkunya® | Vimkunya® (chikungunya vaccine, recombinant) is the first virus-like particle (VLP) single-dose chikungunya vaccine and the first chikungunya vaccine for individuals over the age of 12. It uses virus-like particles designed to mimic the chikungunya virus without the ability to infect cells, replicate or cause disease. | Bavarian Nordic | February 14, 2025 | 2025 | NIH | 7,635,688; 7,094598; 8,106,026; 8,106,027; 8,124,592; 9,353,353; 9,487,563; 10,138,277; 10,369,674; 11,098,084; 11,364,674; 11,718,647; 11,992,523; 12,168,675; 12,281,336 |
Abrysvo® | Abrysvo (respiratory syncytial virus vaccine) is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals, including infants and those pregnant. It was the first RSV vaccine for infants to be approved anywhere in the world. | Pfizer | May 31, 2023 | 2023 | NIH | 9,738,689; 10,858,00; 11,130,785; 11,174,292 |
Amtagvi® | Amtagavi (lifileucel suspension for intravenous infusion) is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma. It is the first and the only one-time, individualized T cell therapy to receive FDA approval for a solid tumor cancer. | Iovance Biotherapeutics Inc | February 16, 2024 | 2024 | NIH | 8,034,334; 8,383,099; 8,287,857; 8,556,882; 9,074,185; 9,844,569; 10,716,809; 11,077,182; 11,331,385; 11,338,032; 11,376,318; 11,401,503; 11,679,128; 11,918,640 |
Arexvy® | Arexvy (respiratory syncytial virus vaccine, adjuvanted) is a vaccine for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. Based on a recombinant subunit prefusion RSV F glycoprotein antigen it is the first RSV vaccine for older adults to be approved anywhere in the world. | GlaxoSmithKline | May 3, 2023 | 2023 | NIH | 9,738,689; 10,858,400; 11,130,785; 11,174,292 |
Spikevax® | Spikevax (COVID-19 vaccine, mRNA) is a messenger RNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. | ModernaTX Inc. | January 31, 2022 | 2020 (EUA) | NIH | 10,960,070 |
Comirnaty® | Comirnaty (COVID-19 vaccine, mRNA) is a messenger RNA vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. | BioNTech/Pfizer | August 23, 2021 | 2020 (EUA) | NIH | 10,960,070 |
Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and tenofovir disoproxil fumarate (generic) is used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection | CIPLA | April 2, 2021 | 2021 | CDC | 9,044,509; 9,579,333; 9,937,191; 10,335,423 |
Abecma® | Abecma (idecabtagene viceocel) is a chimeric antigen receptor (CAR) T-cell therapy treatment for multiple myeloma. It is used for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies. | Bluebird Bio | March 26, 2021 | 2021 | NIH | 9,765,342; 10,767,184; 10,815,487; 10,738,312; 10,738,313; 10,844,387; 10,829,767; 10,900,042; 10,876,123; 10,815,488; 10,829,768; 10,837,019; 10,829,769 |
Ebanga® | Ebanga (ansuvimab-zykl) is a human monoclonal antibody for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell. | Ridgeback Biotherapeutics | December 21, 2020 | 2021 | NIH | 10,160,795; 10,273,288 |
Zokinvy® | Zokinsky (lonafarnib) is a farnesyltransferase inhibitor that helps prevent the buildup of defective progerin or progerin-like protein of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL). Hutchinson-Gilford and progeroid laminopathies are two distinct fatal diseases marked by premature aging. | Progeria Research Foundation/Elger Biopharmaceuticals | November 20, 2020 | 2021 | NIH | 7,838,531; 8,257,915; 8,691,501; 8,828,356 |
Tecartus® | Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy for the treatment of mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (ALL). | Kite Pharma | July 24, 2020 | 2020 | NIH | 9,855,298; 10,322,146 |
Descovy® | Descovy® (tenofovir alafenamide plus emtricitabine) is used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection for individuals not at-risk from receptive vaginal sex. | Gilead Sciences | October 3, 2019 | 2019 | CDC | 9,044,509; 9,579,333; 9,937,191; 10,335,423 |
Emtricitabine and Tenofovir Disoproxil Fumarate | Emtricitabine and tenofovir disoproxil fumarate (generic) is used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. | Larus Labs | July 26, 2019 | 2019 | CDC | 9,044,509; 9,579,333; 9,937,191; 10,335,423 |
Spravato® | 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). | Janssen Therapeutics | March 6, 2019 | 2019 | NIH | 8,785,500; 9,539,220; 9,592,207 |
Lumoxiti® | 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). | AstraZeneca | September 13, 2018 | 2019 | NIH | 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 |
Yescarta® | 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. | Kite Pharma | October 18, 2017 | 2018 | NIH | 9,855,298; 10,322,146 |
Ella® | A progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. | Laboratoire HRA Pharma | March 10, 2015 | 2016 | NIH | 9,283,233; 9,616,073; 10,159,681 |
Myalept® | Myaylept (metreleptin) is an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Lipodystrophy is a rare disorder characterized by loss or lack of adipose tissue resulting in the deficiency of the hormone leptin, produced by fat cells and is associated with severe metabolic abnormalities including severe insulin resistance, diabetes, hypertriglyceridemia and fatty liver disease. | Aegerion Pharmaceuticals Inc. | February 25, 2014 | 2014 | NIH | 7,183,254; 8,318,666 |
Truvada® | Truvada® (emtricitabine and tenofovir disoproxil fumarate) is used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. It represents a significant milestone in HIV prevention, marking the first time a drug has been approved for this purpose. | Gilead Sciences | July 16, 2012 | 2012 | CDC | 9,044,509; 9,579,333; 9,937,191; 10,335,423 |
Velcade® | 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. | Millennium Pharmaceuticals | May 13, 2003 | 2003 | NIH | 6,699,835; 6,713,446; 6,958,319; 7,109,323 |
Other Licenses
View the Currently Licensed Products Developed Using HHS Technologies
| Product Name | Description | Licensee | FDA Approval | First Commercial U.S. Sale | Agency | U.S. Patents |
|---|---|---|---|---|---|---|
| Roctavian® | Roctavian® (valoctocogene roxaparvovec-rvox) is an adeno-associated virus vector-based gene therapy for the treatment of adults with severe hemophilia A. | BioMarin Pharmaceutical | June 28, 2023 | 2023 | NIH | 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 |
| Hemgenix® | Hemgenix (etranacogene dezaparvovec-drlb) is a one-time gene therapy for the treatment of adults 18 years of age and older living with hemophilia B. | uniQure/CSL | November 22, 2022 | 2022 | NIH | 6,855,314; 6,984,517; 7,271,002; 7,479,554 |
| Dengvaxia® | Dengvaxia® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. Dengvaxia is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. | Sanofi Pasteur | May 1, 2019 | 2019 | NIH | 6,184,024; 6,676,936 |
| Gardasil 9® | A new vaccine to protect against human papilloma virus (HPV) for use in males and females aged 9 to 45. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine. | Merck & Co. Inc. | October 5, 2018 | 2019 | NIH | 5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386 |
| Luxturna® | Luxturna (voretigene neparvovec-rzyl) is a new gene therapy to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene. | Spark Therapeutics | December 18, 2017 | 2018 | NIH | 7,419,817 |
| Symtuza® | Symtuza is a four-drug combination of darunavir (DRV), a human immunodeficiency virus (HIV-1) protease inhibitor, cobicistat (COBI), a CYP3A inhibitor, and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients. | Janssen Therapeutics | July 17, 2018 | 2019 | NIH | 7,470,506; 8,597,876; 9,889,115 |
| Zinbryta® | Monthly injectable interleukin-2 receptor blocking antibody for treating relapsing forms of multiple sclerosis in patients who failed to respond to two or more previous therapies. | Biogen | May 27, 2016 | 2016 | NIH | 7,575,742; 8,298,525; 8,636,997 |
| Prezcobix® | Prezcobix is a two-drug combination of darunavir, a human immunodeficiency virus (HIV-1) protease inhibitor, and cobicistat, a CYP3A inhibitor, and is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced. | Janssen Therapeutics | January 25, 2015 | 2015 | NIH | 7,470,506; 8,597,876; 9,889,115 |
| Zilver PTX Drug-Eluting Peripheral Stent | This is the first drug-eluting stent approved to treat peripheral arterial disease in the superficial femoral artery. This device combines the mechanical support of stenting with the drug paclitaxel to reduce the risk of restenosis. | Angiotech/Cook Medical | November 15, 2012 | 2012 | NIH | 5,616,608; 6,403,635; 6,429,232; 6,500,859 |
| Cervarix® | Cervarix® is a bivalent Human Papilloma Virus (HPV) vaccine that protects against infection by HPV16 and HPV18 viruses. Infections from these viruses have been etiologically linked to cervical cancer. | MedImmune Inc./GlaxoSmithKline | October 16, 2009 | 2009 | NIH | 5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386 |
| Prezista® | A novel protease inhibitor for the treatment of HIV-1 in patients who are non-responsive to existing antiretroviral therapies. Prezista® is approved for use in combination with low-dose administration of ritonavir, which helps decrease the breakdown of Prezista® in the body, thereby enhancing drug efficacy. | Tibotec Pharmaceuticals Ltd. | June 23, 2006 | 2006 | NIH | 7,470,506; 8,597,876; 9,889,115 |
| Gardasil® | A new vaccine to protect against cervical cancer, currently approved for use in females aged 9 to 26. Gardasil® prevents infection against four forms of Human Papilloma Virus (HPV): HPV16, HPV18, HPV6, and HPV11. | Merck & Co. Inc. | June 8, 2006 | 2006 | NIH | 5,437,951; 5,618,536; 5,709,996; 5,716,620; 5,744,142; 5,756,284; 5,855,841; 5,871,998; 5,985,610; 7,220,419; 7,361,356; 7,462,356; 7,691,386 |
| Kepivance® | 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. | Amgen Inc. | December 15, 2004 | 2005 | NIH | 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 |
| Didanosine Delayed-Release Capsules | Generic equivalent for Videx® EC, a treatment of HIV infection with ddI. Selectively inhibits the replication of HIV by interfering with a critical element known as reverse transcriptase. Because of being better tolerated or having a different pattern of toxicity than other treatments, patients may find it useful in either individual or combination treatment therapy. | Barr Laboratories | December 3, 2004 | 2005 | NIH | 4,861,759; 5,026,687; 5,254,539; 5,376,642; 5,616,566 |
| Taxus Express2 Monorail Paclitaxel-Eluting Coronary Stent System | Treatment of coronary artery disease by balloon angioplasty and placement of a stent is often followed by restenosis caused by cellular proliferation. The Taxus Express2® stent system contains two medical components: the Express2 coronary stent and paclitaxel contained in a polymer coating. NIH researchers discovered that the paclitaxel component inhibits cellular proliferation and subsequent restenosis thus leading to greatly improved medical outcomes. | Angiotech/Boston Scientific | March 4, 2004 | 2004 | NIH | 5,616,608; 6,403,635; 6,429,232; 6,500,859 |
| Zevalin® | A treatment for non-Hodgkin's lymphoma, which affects 50,000 Americans annually. A majority of these cases are low-grade lymphomas that do not respond to other treatments. Treatment with Zevalin®, which is simple and fast, and has less severe side effects, is especially suited for these patients. This drug combines the targeting power of monoclonal antibodies with the cell killing ability of radioactive atoms, and is the first radioimmunotherapy to be approved by the FDA. | IDEC Pharmaceuticals | February 19, 2002 | 2002 | NIH | 4,831,175; 5,099,069; 5,246,692 |
| Twinrix® | A vaccine formulation that combines both Hepatitis A and Hepatitis B. Combining the two vaccines, for two of the most common infectious diseases that represent serious public health problems, Twinrix® offers significant advantages such as increased convenience for patient and physician, fewer injections and greater compliance compared with two separate vaccines. | GlaxoSmithKline | May 11, 2001 | 2001 | NIH | 4,532,215; 4,620,978; 4,636,469; 6,113,912; 6,180,110; 6,423,318; 6,680,060 |
| NeoTect® | A synthetic peptide radiopharmaceutical used for the diagnosis of lung cancer. The probe binds to somatostatin receptor-bearing masses in the lungs, and offers additional information to the physician. The procedure, being minimally invasive, carries much reduced risk compared to invasive procedures like biopsies. | Berlex Laboratories formerly Diatide Inc. | August 3, 1999 | 1999 | NIH | 5,066,716 |
| LYMErix® | The world's first vaccine for the prevention of Lyme disease. Lyme disease is one of the fastest vector-borne diseases in the US. It can lead to severe and debilitating problems such as arthritis, heart abnormalities and Bell's palsy. | GlaxoSmithKline | December 21, 1998 | 1999 | NIH | 4,578,355; 4,925,799 |
| Thyrogen® | A recombinant form of human thyroid stimulating hormone (TSH) for use in follow-up screening of patients who have been treated for thyroid cancer. Thyrogen® permits these patients to avoid the debilitating effects of thyroid hormone withdrawal while undergoing standard diagnostic procedures such as serum thyroglobulin testing and radioiodine imaging. | Genzyme Corp. | November 30, 1998 | 1998 | NIH | 6,117,991; 6,284,491 |
| AcuTect® | A synthetic peptide radiopharmaceutical used for the detection of acute deep venous thrombosis (DVT). DVT affects an estimated 5 million individuals in the U.S. each year and is the most common source of pulmonary embolism. AcuTect® is the first in-vivo imaging agent to target acute DVT in the lower extremities. | Berlex Laboratories formerly Diatide Inc. | September 14, 1998 | 1998 | NIH | 5,066,716 |
| RotaShield® | A live oral vaccine for the prevention of rotavirus gastroenteritis in infants. Rotavirus is the single most common cause of epidemic severe acute gastroenteritis (diarrhea and vomiting) in infants and children from both developed and developing countries. RotoShield® is the first rotavirus vaccine approved for use in humans. | Wyeth Laboratories Inc. | August 31, 1998 | 1998 | NIH | 4,571,385; 4,704,275; 4,751,080 |
| Vitravene® | A phosphorothioate oligonucleotide that inhibits cytomeglovirus (CMV) infections in the eye. Such infections commonly occur in immunocompromised patients with resultant damage to the retina. Vitravene® is the first antisense therapeutic approved for use in humans. | Isis Pharmaceuticals Inc. | August 26, 1998 | 1998 | NIH and FDA | 5,003,097; 5,264,423; 5,276,019; 5,286,717 |
| Certiva® | A combined diphtheria, tetanus and acellular pertussis vaccine for use in infants and children. A special process that reduces local and systemic adverse events commonly associated with traditional whole-cell DPT vaccine administration has detoxified the acellular pertussis component of this vaccine. Certiva® was the first pediatric vaccine introduced into the U.S. market by a new independent vaccine producer in over ten years. | Baxter Pharmaceuticals formerly North American Vaccine Inc. | July 29, 1998 | 1998 | NIH | 4,762,710; 5,338,670 |
| Synagis® | A monoclonal antibody used for the prevention and treatment of serious lower respiratory tract disease by respiratory syncytial virus (RSV). RSV is the most common cause of pneumonia and bronchiolitis in infancy and early childhood. Synagis is the world's first monoclonal antibody licensed by the FDA for any infectious disease. | MedImmune Inc. | June 19, 1998 | 1998 | NIH | Biological Material License |
| Zenapax® | A humanized monoclonal antibody used for the prevention of acute kidney transplant rejection. This recombinantly produced antibody achieves its immunosuppressive properties by binding to the alpha (or Tac) subunit of human interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes. | Protein Design Laboratory/Hoffman-LaRoche | December 10, 1997 | 1998 | NIH | 7,094,404 |
| Sporanox Oral Solution | Oral formulation of the anti-fungal agent itraconazole that is used for the treatment of painful and debilitating fungal infections of the esophagus and mouth, commonly called thrush. Itraconazole is solubilized for this application through coupling with hydroxy-propyl-cyclodextrin, a molecular inclusion complex. | Janssen Pharmaceuticals | February 21, 1997 | 1997 | NIH | 4,727,064; 5,096,893 |
| Havrix® | A vaccine from the isolation of Hepatitis A virus strain HM-175. Hepatitis A is probably the most widespread of viral hepatitis diseases and is an endemic childhood disease in the underdeveloped countries of the world. | GlaxoSmithKline | February 22, 1995 | 1997 | NIH | 4,727,064; 5,096,893 |
| NeuTrexin® | A treatment using trimetrexate as an anti-parasitic agent for infection. Infections due to Toxoplasma gondii and Pneumocystis carinii, as seen in AIDS patients are extremely refractory to standard therapy can be effectively treated by administering this drug. | MedImmune Inc. | December 17, 1993 | 1994 | NIH | 4,694,007 |
| Taxol® | An improved method for administering Taxol® (paclitaxel) has significantly improved the treatment of cancerous tumors, particularly advanced stage epithelial ovarian and breast cancers. Paclitaxel is a compound derived from the bark of the Western Yew tree. | Bristol-Myers Squibb | December 29, 1992 | 1996 | NIH | 5,496,804; 5,496,846; 6,150,398 |
| Hivid® | A treatment of HIV infection with ddC. Inhibits the replication of HIV by interfering with the critical enzyme reverse transcriptase. Patients find it useful in either individual or combination treatment therapy. | Hoffmann-LaRoche | June 19, 1992 | 1992 | NIH | 4,879,277 |
| Videx® | A treatment of HIV infection with ddI. Selectively inhibits the replication of HIV by interfering with a critical element known as reverse transcriptase. Because of being better tolerated or having a different pattern of toxicity than other treatments, patients may find it useful in either individual or combination treatment therapy. | Bristol-Myers Squibb | October 9, 1991 | 1991 | NIH | 4,861,759; 5,026,687; 5,254,539; 5,376,642; 5,616,566 |
| Fludara® | A DNA polymerase inhibitor (fludarabine) that has been shown to have potent activity in the treatment of B-cell leukemia. This compound is a cancer chemotherapeutic drug, 2-F-araA. | Berlex Laboratories | April 18, 1991 | 1991 | NIH | 4,188,378; 4,210,745; 4,357,324 |