Patent and Exclusivity Expirations Report
Report generated for the week of 2025-07-07 by Unibest Digital Center. Current analysis scope only include the US FDA.
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Summary of Expirations
This week, there are 13 drugs in the patent and exclusivity list. They are:
Biktarvy by Gilead Sciences Inc, containing active ingredient Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate
Odefsey by Gilead Sciences Inc, containing active ingredient Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate
Vemlidy by Gilead Sciences Inc, containing active ingredient Tenofovir Alafenamide Fumarate
Genvoya by Gilead Sciences Inc, containing active ingredient Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate
Descovy by Gilead Sciences Inc, containing active ingredient Emtricitabine; Tenofovir Alafenamide Fumarate
Omegaven by Fresenius Kabi USA LLC, containing active ingredient Fish Oil Triglycerides
Veregen by ANI Pharmaceuticals Inc, containing active ingredient Sinecatechins
Promacta Kit by Novartis Pharmaceuticals Corp, containing active ingredient Eltrombopag Olamine
Promacta by Novartis Pharmaceuticals Corp, containing active ingredient Eltrombopag Olamine
Qtern by AstraZeneca AB, containing active ingredient Dapagliflozin; Saxagliptin Hydrochloride
Inqovi by Taiho Oncology Inc, containing active ingredient Cedazuridine; Decitabine
Gilotrif by Boehringer Ingelheim, containing active ingredient Afatinib Dimaleate
TPOXX by SIGA Technologies Inc, containing active ingredient Tecovirimat
Patents Expiring This Week
TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - VEMLIDY
From GILEAD SCIENCES INC; antiviral tablet that may be used to treat chronic hepatitis B virus (HBV) infection in adults and children aged 6 years of age and older and weighing at least 55 pounds (25 kg) with stable (compensated) liver disease.
EQ 25MG BASE
Approved in Nov 10, 2016, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2032-08-15, and the latest expires on 2033-02-15.
| Patent No | Patent Expiration Date | Patent Title |
| 7390791*PED | 2025-07-07 | Prodrugs of phosphonate nucleotide analogues |
BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - BIKTARVY
From GILEAD SCIENCES INC; a complete HIV-1 treatment in a once-a-day single tablet, which is sometimes shortened to BIC/FTC/TAF.
EQ 50MG BASE;200MG;EQ 25MG BASE
Approved in Feb 7, 2018, used as Reference Listed Drug and Reference Standard
EQ 30MG BASE;120MG;EQ 15MG BASE
Approved in Oct 7, 2021, used as Reference Listed Drug
There are 10 future patent(s) for this application. The earliest expires on 2032-08-15, and the latest expires on 2036-11-08.
| Patent No | Patent Expiration Date | Patent Title |
| 7390791*PED | 2025-07-07 | Prodrugs of phosphonate nucleotide analogues |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - ODEFSEY
From GILEAD SCIENCES INC; a complete HIV-1 treatment in a once-a-day single tablet, which is sometimes shortened to FTC/R/TAF.
200MG;EQ 25MG BASE;EQ 25MG BASE
Approved in Mar 1, 2016, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2032-08-15, and the latest expires on 2033-02-15.
| Patent No | Patent Expiration Date | Patent Title |
| 7390791*PED | 2025-07-07 | Prodrugs of phosphonate nucleotide analogues |
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - DESCOVY
From GILEAD SCIENCES INC; for the treatment of HIV-1, and this was extended on October 3, 2019, to include HIV PrEP. When used to prevent HIV-1 infection, it is the only tablet needed to prevent HIV.
200MG;EQ 25MG BASE
Approved in Apr 4, 2016, used as Reference Listed Drug and Reference Standard
120MG;EQ 15MG BASE
Approved in Jan 7, 2022, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2032-08-15, and the latest expires on 2033-02-15.
| Patent No | Patent Expiration Date | Patent Title |
| 7390791*PED | 2025-07-07 | Prodrugs of phosphonate nucleotide analogues |
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - GENVOYA
From GILEAD SCIENCES INC; for the treatment of HIV-1.
150MG;150MG;200MG;EQ 10MG BASE
Approved in Nov 5, 2015, used as Reference Listed Drug and Reference Standard
There are 18 future patent(s) for this application. The earliest expires on 2026-08-27, and the latest expires on 2033-04-06.
| Patent No | Patent Expiration Date | Patent Title |
| 7390791*PED | 2025-07-07 | Prodrugs of phosphonate nucleotide analogues |
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE - TABLET;ORAL - QTERN
From ASTRAZENECA AB; used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus, and used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.
10MG;EQ 5MG BASE
Approved in Feb 27, 2017, used as Reference Listed Drug and Reference Standard
5MG;EQ 5MG BASE
Approved in May 2, 2019, used as Reference Listed Drug
There are 12 future patent(s) for this application. The earliest expires on 2025-10-04, and the latest expires on 2030-06-16.
| Patent No | Patent Expiration Date | Patent Title |
| 8628799 | 2025-07-13 | Coated tablet formulation and method |
ELTROMBOPAG OLAMINE - FOR SUSPENSION;ORAL - PROMACTA KIT
From NOVARTIS PHARMACEUTICALS CORP; a man-made form of a protein that stimulates cells in the bone marrow to produce more platelets.
EQ 25MG ACID/PACKET
Approved in Aug 24, 2015, used as Reference Listed Drug and Reference Standard
EQ 12.5MG ACID/PACKET
Approved in Sep 27, 2018, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2026-01-13, and the latest expires on 2026-01-13.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7547719 | U-1736 | TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP) | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-1575 | PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-1306 | TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-2452 | COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
ELTROMBOPAG OLAMINE - TABLET;ORAL - PROMACTA
From NOVARTIS PHARMACEUTICALS CORP; a man-made form of a protein that stimulates cells in the bone marrow to produce more platelets.
EQ 75MG ACID
Approved in Sep 8, 2009, used as Reference Listed Drug and Reference Standard
EQ 50MG ACID; EQ 25MG ACID
Approved in Nov 20, 2008, used as Reference Listed Drug
EQ 12.5MG ACID
Approved in Oct 20, 2011, used as Reference Listed Drug
There are 11 future patent(s) for this application. The earliest expires on 2026-01-13, and the latest expires on 2028-02-01.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7547719 | U-1306 | TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-2452 | COMBINATION WITH IMMUNOSUPPRESSIVE THERAPY FOR FIRST-LINE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS AND OLDER WITH SEVERE APLASTIC ANEMIA | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-2451 | TREATMENT OF THROMBOCYTOPENIA IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER WITH CHRONIC IMMUNE (IDIOPATHIC) THROMBOCYTOPENIA (ITP) | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
| 7547719 | U-1575 | PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO IMMUNOSUPPRESSIVE THERAPY | 2025-07-13 | 3′-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hy-drazino]-2′-hydroxy-[1,1′-piphenyl]-acid bis-(monoethanolamine) |
FISH OIL TRIGLYCERIDES - EMULSION;INTRAVENOUS - OMEGAVEN
From FRESENIUS KABI USA LLC; used to aid diet needs.
10GM/100ML (0.1GM/ML); 5GM/50ML (0.1GM/ML)
Approved in Jul 27, 2018, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9566260 | U-2366 | TREATMENT OF LIVER DISEASE THROUGH NUTRITION FOR PATIENTS UNDER THE AGE OF 12 | 2025-07-11 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) |
| 9629821 | U-2367 | USE FOR PATIENTS WITH PARENTERAL NUTRITION ASSOCIATED CHOLESTASIS OR PARENTERAL NUTRITION ASSOCIATED LIVER DISEASE | 2025-07-11 | Treatment and prevention of liver disease associated with parenteral nutrition (PN) |
SINECATECHINS - OINTMENT;TOPICAL - VEREGEN
From ANI PHARMACEUTICALS INC; a herbal product made from green tea leaves to treat genital and anal warts in adults.
15%
Approved in Oct 31, 2006, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2026-10-02, and the latest expires on 2026-10-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9770406 | U-172 | TREATMENT OF GENITAL WARTS | 2025-07-12 | Medicament for the treatment of viral skin and tumour diseases |
Exclusivities Expiring This Week
AFATINIB DIMALEATE - TABLET;ORAL - GILOTRIF
From BOEHRINGER INGELHEIM; used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with non-resistant EGFR mutations or resistance to platinum-based chemotherapy.
EQ 40MG BASE
Approved in Jul 12, 2013, used as Reference Listed Drug and Reference Standard
EQ 20MG BASE; EQ 30MG BASE
Approved in Jul 12, 2013, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-07, and the latest expires on 2025-10-07.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-12 | PEDIATRIC EXCLUSIVITY |
CEDAZURIDINE; DECITABINE - TABLET;ORAL - INQOVI
From TAIHO ONCOLOGY INC; used to treat treat adults with myelodysplastic syndromes (MDS, including chronic myelomonocytic leukemia (CMML).
100MG;35MG
Approved in Jul 7, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-07-07, and the latest expires on 2027-07-07.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-07 | NEW CHEMICAL ENTITY |
TECOVIRIMAT - CAPSULE;ORAL - TPOXX
From SIGA TECHNOLOGIES INC; used to treat smallpox, monkeypox, and cowpox.
200MG
Approved in Jul 13, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-13 | INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE CAUSED BY VARIOLA VIRUS IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 13 KG |
