Patent and Exclusivity Expirations Report
Report generated for the week of 2025-04-21 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 18 drugs in the patent and exclusivity list. They are:
Juluca by VIIV Healthcare, containing active ingredient Dolutegravir Sodium and Rilpivirine Hydrochloride
Edurant by Janssen Products, containing active ingredient Rilpivirine Hydrochloride
Odefsey by Gilead Sciences, containing active ingredient Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Alafenamide Fumarate
Cabenuva Kit by VIIV Healthcare, containing active ingredient Cabotegravir and Rilpivirine
Complera by Gilead Sciences, containing active ingredient Emtricitabine, Rilpivirine Hydrochloride, and Tenofovir Disoproxil Fumarate
Vyxeos by Celator Pharmaceuticals, containing active ingredient Cytarabine and Daunorubicin
Fotivda by AVEO Pharmaceuticals, containing active ingredient Tivozanib Hydrochloride
Anoro Ellipta by GlaxoSmithKline, containing active ingredient Umeclidinium Bromide and Vilanterol Trifenatate
Trelegy Ellipta by GlaxoSmithKline, containing active ingredient Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate
Incruse Ellipta by GlaxoSmithKline, containing active ingredient Umeclidinium Bromide
Stendra by Metuchen Pharmaceuticals, containing active ingredient Avanafil
Abraxane by Bristol-Myers Squibb, containing active ingredient Paclitaxel
Zerbaxa by Cubist Pharmaceuticals, containing active ingredient Ceftolozane Sulfate and Tazobactam Sodium
Epsolay by Galderma Laboratories, containing active ingredient Benzoyl Peroxide
Jynarque by Otsuka Pharmaceutical, containing active ingredient Tolvaptan
Ongentys by Amneal Pharmaceuticals, containing active ingredient Opicapone
Veklury by Gilead Sciences, containing active ingredient Remdesivir
Epclusa by Gilead Sciences, containing active ingredient Sofosbuvir and Velpatasvir
Patents Expiring This Week
AVANAFIL - TABLET;ORAL - STENDRA
From METUCHEN PHARMACEUTICALS LLC; for the treatment of erectile dysfunction.
50MG; 100MG
Approved in Apr 27, 2012, used as Reference Listed Drug
200MG
Approved in Apr 27, 2012, 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 |
| 6656935 | U-155 | TREATMENT OF ERECTILE DYSFUNCTION | 2025-04-27 | Aromatic nitrogen-containing 6-membered cyclic compounds |
CABOTEGRAVIR; RILPIVIRINE - SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR - CABENUVA KIT
From VIIV HEALTHCARE CO; a long-acting HIV treatment used to keep HIV levels undetectable in patients 12 years and older.
400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)
600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)
Approved in Jan 21, 2021, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2026-04-28, and the latest expires on 2038-07-18.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7125879 | U-3348 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
CYTARABINE; DAUNORUBICIN - POWDER;INTRAVENOUS - VYXEOS
From CELATOR PHARMACEUTICALS INC; for the treatment of acute myeloid leukemia that is newly diagnosed in adults and children at least 1 year old.
100MG;44MG
Approved in Aug 3, 2017, used as Reference Listed Drug and Reference Standard
There are 8 future patent(s) for this application. The earliest expires on 2026-06-07, and the latest expires on 2032-10-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8431806 | U-3147 | FOR THE TREATMENT OF NEWLY-DIAGNOSED THERAPY-RELATED ACUTE MYELOID LEUKEMIA (T-AML) OR AML WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) IN ADULTS AND PEDIATRIC PATIENTS 1 YEAR AND OLDER | 2025-04-22 | Liposomal formulations of anthracycline agents and cytidine analogs |
DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE - TABLET;ORAL - JULUCA
From VIIV HEALTHCARE CO; for the treatment of HIV/AIDS.
EQ 50MG BASE;EQ 25MG BASE
Approved in Nov 21, 2017, used as Reference Listed Drug and Reference Standard
There are 6 future patent(s) for this application. The earliest expires on 2027-10-05, and the latest expires on 2038-09-05.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7125879 | U-257 | TREATMENT OF HIV INFECTION | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE - TABLET;ORAL - ODEFSEY
From GILEAD SCIENCES INC; for the treatment of HIV/AIDS.
200MG;EQ 25MG BASE;EQ 25MG BASE
Approved in Mar 1, 2016, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-07-07, and the latest expires on 2033-02-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7125879 | U-257 | TREATMENT OF HIV INFECTION | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - TABLET;ORAL - COMPLERA
From GILEAD SCIENCES INC; for the treatment of HIV/AIDS.
200MG;EQ 25MG BASE;300MG
Approved in Aug 10, 2011, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2025-12-09, and the latest expires on 2033-01-14.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7125879 | U-257 | TREATMENT OF HIV INFECTION | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - TRELEGY ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; for the treatment of COPD, including bronchitis and emphysema, and also for asthma in adults as a maintenance treatment.
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Sep 18, 2017, used as Reference Listed Drug and Reference Standard
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Sep 9, 2020, used as Reference Listed Drug and Reference Standard
There are 16 future patent(s) for this application. The earliest expires on 2025-05-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8309572 | U-2129 | METHOD OF INHIBITING THE BINDING OF ACETYLCHOLINE TO AN ACETYLCHOLINE RECEPTOR IN THE RESPIRATORY TRACT OF A HUMAN, COMPRISING CONTACTING THE RECEPTOR WITH AN EFFECTIVE AMOUNT OF UMECLIDINIUM, VIA TOPICAL APPLICATION | 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
| 7498440 |
|
| 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
PACLITAXEL - POWDER;INTRAVENOUS - ABRAXANE
From BRISTOL-MYERS SQUIBB CO; for the treatment of advanced cancer of the breast, lung, or pancreas.
100MG/VIAL
Approved in Jan 7, 2005, used as Reference Listed Drug and Reference Standard
There are 14 future patent(s) for this application. The earliest expires on 2026-02-21, and the latest expires on 2034-07-12.
| Patent No | Patent Expiration Date | Patent Title |
| 7820788*PED | 2025-04-27 | Compositions and methods of delivery of pharmacological agents |
RILPIVIRINE HYDROCHLORIDE - TABLET;ORAL - EDURANT
From JANSSEN PRODUCTS LP; for the treatment of previously untreated HIV-1 infection in adults and children aged 2 years of age and older, weighing at least 14 kg, with HIV-1 RNA less than or equal to 100,000 copies/mL.
EQ 25MG BASE
Approved in May 20, 2011, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2025-10-21, and the latest expires on 2025-10-21.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7125879 | U-1740 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
| 7125879 | U-1153 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
| 7125879 | U-3874 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN ANTIRETROVIRAL TREATMENT-NAIVE PATIENTS 2 YEARS OF AGE AND OLDER, WEIGHING AT LEAST 14KG, WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
| 7125879 | U-3353 | TREATMENT IN COMBINATION WITH CABOTEGRAVIR OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 AND OLDER TO REPLACE CURRENT REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
| 7125879 | U-1307 | IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO 100,000 AT THE START OF THERAPY | 2025-04-21 | HIV inhibiting pyrimidines derivatives |
TIVOZANIB HYDROCHLORIDE - CAPSULE;ORAL - FOTIVDA
From AVEO PHARMACEUTICALS INC; for the treatment of adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.
EQ 0.89MG BASE
Approved in Mar 10, 2021, used as Reference Listed Drug
EQ 1.34MG BASE
Approved in Mar 10, 2021, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2039-11-05, and the latest expires on 2039-11-05.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 6821987 | U-3100 | A METHOD OF TREATING ADULTS WITH RELAPSED OR REFRACTORY ADVANCED RENAL CELL CARCINOMA FOLLOWING TWO OR MORE PRIOR SYSTEMIC THERAPIES BY INHIBITING THE ANGIOGENESIS OF BLOOD VESSELS WITH A VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITOR | 2025-04-26 | Quinoline derivatives and quinazoline derivatives having azolyl group |
UMECLIDINIUM BROMIDE - POWDER;INHALATION - INCRUSE ELLIPTA
From GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE; for the prevention of airflow obstruction and reduce flare-ups in adults with COPD, including bronchitis and emphysema.
EQ 0.0625MG BASE/INH
Approved in Apr 30, 2014, used as Reference Listed Drug and Reference Standard
There are 5 future patent(s) for this application. The earliest expires on 2025-07-27, and the latest expires on 2030-10-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7498440 |
|
| 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
| 8309572 | U-1476 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA. | 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - ANORO ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; for the prevention of airflow obstruction and reduce flare-ups in adults with COPD, including bronchitis and emphysema.
EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
Approved in Dec 18, 2013, used as Reference Listed Drug and Reference Standard
There are 16 future patent(s) for this application. The earliest expires on 2025-05-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8309572 | U-1476 | INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA. | 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
| 7498440 |
|
| 2025-04-27 | Muscarinic acetylcholine receptor antagonists |
Exclusivities Expiring This Week
BENZOYL PEROXIDE - CREAM;TOPICAL - EPSOLAY
From GALDERMA LABORATORIES LP; for the treatment of adults with pimples and bumps caused by a condition called rosacea.
5%
Approved in Apr 22, 2022, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-22 | NEW PRODUCT |
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - POWDER;INTRAVENOUS - ZERBAXA
From CUBIST PHARMACEUTICALS LLC; for the treatment of certain bacterial infections of the lungs, stomach, or urinary tract.
EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Approved in Dec 19, 2014, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-21 | NEW PATIENT POPULATION |
OPICAPONE - CAPSULE;ORAL - ONGENTYS
From AMNEAL PHARMACEUTICALS LLC; for the treatment of symptoms of "off" episodes (stiffness, tremors, muscle spasms, poor muscle control) in people with Parkinson's disease.
25MG
Approved in Apr 24, 2020, used as Reference Listed Drug
50MG
Approved in Apr 24, 2020, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-24 | NEW CHEMICAL ENTITY |
REMDESIVIR - POWDER;INTRAVENOUS - VEKLURY
From GILEAD SCIENCES INC; for the treatment of COVID-19 in adults and children from birth who weigh at least 3.3 pounds (1.5 kilograms) and are hospitalized or are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
100MG/VIAL
Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-21, and the latest expires on 2027-01-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-25 | NEW PATIENT POPULATION |
REMDESIVIR - SOLUTION;INTRAVENOUS - VEKLURY
From GILEAD SCIENCES INC; for the treatment of COVID-19 in adults and children from birth who weigh at least 3.3 pounds (1.5 kilograms) and are hospitalized or are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
100MG/20ML (5MG/ML)
Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2025-07-21, and the latest expires on 2027-01-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-25 | NEW PATIENT POPULATION |
SOFOSBUVIR; VELPATASVIR - PELLETS;ORAL - EPCLUSA
From GILEAD SCIENCES INC; for the treatment of chronic hepatitis C in adults and children 3 years of age and older.
150MG;37.5MG/PACKET
Approved in Jun 10, 2021, used as Reference Listed Drug
200MG;50MG/PACKET
Approved in Jun 10, 2021, used as Reference Listed Drug and Reference Standard
There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2028-06-10, and the latest expires on 2028-12-10.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-27 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
SOFOSBUVIR; VELPATASVIR - TABLET;ORAL - EPCLUSA
From GILEAD SCIENCES INC; for the treatment of chronic hepatitis C in adults and children 3 years of age and older.
200MG;50MG
Approved in Mar 19, 2020, used as Reference Listed Drug
400MG;100MG
Approved in Jun 28, 2016, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2027-03-19, and the latest expires on 2028-12-10.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-27 | UPDATES THE US PRESCRIBING INFORMATION WITH CLINICAL DATA REGARDING THE USE OF SOFOSBUVIR AND VELPATASVIR FOR THE TREATMENT OF CHRONIC HCV GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION IN PEOPLE WHO INJECT DRUGS (PWID), INCLUDING THOSE ON MEDICATION-ASSISTED TREATMENT (MAT) FOR OPIOID USE DISORDER |
TOLVAPTAN - TABLET;ORAL - JYNARQUE
From OTSUKA PHARMACEUTICAL CO LTD; for slowing kidney function decline in patients at risk for rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Also used to treat hypervolemic and euvolemic hyponatremia.
15MG; 30MG; 60MG; 90MG
Approved in Apr 23, 2018, used as Reference Listed Drug
45MG
Approved in Apr 23, 2018, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-23 | INDICATED TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD) |
