Patent and Exclusivity Expirations Report
Report generated for the week of 2025-07-21 by Unibest Digital Center. Current analysis scope only include the US FDA.
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Summary of Expirations
This week, there are 12 drugs in the patent and exclusivity list. They are:
Valtoco by Neurelis Inc, containing active ingredient Diazepam
Osphena by Duchesnay Inc, containing active ingredient Ospemifene
Zydelig by Gilead Sciences Inc, containing active ingredient Idelalisib
Winlevi by Sun Pharmaceutical Industries Ltd, containing active ingredient Clascoterone
Zokinvy by Sentynl Therapeutics Inc, containing active ingredient Lonafarnib
Trelegy Ellipta by GlaxoSmithKline, containing active ingredients Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol Trifenatate
Anoro Ellipta by GlaxoSmithKline, containing active ingredients Umeclidinium Bromide and Vilanterol Trifenatate
Incruse Ellipta by GlaxoSmithKline, containing active ingredient Umeclidinium Bromide
Veklury by Gilead Sciences Inc, containing active ingredient Remdesivir
Lutathera by Advanced Accelerator Applications USA Inc, containing active ingredient Lutetium Lu 177 Dotatate
Kyzatrex by Marius Pharmaceuticals LLC, containing active ingredient Testosterone Undecanoate
Omegaven by Fresenius Kabi USA LLC, containing active ingredient Fish Oil Triglycerides
Patents Expiring This Week
CLASCOTERONE - CREAM;TOPICAL - WINLEVI
From SUN PHARMACEUTICAL INDUSTRIES LTD; an androgen receptor antagonist used for the topical treatment of acne vulgaris in patients 12 years of age and older.
1%
Approved in Aug 26, 2020, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2026-01-12, and the latest expires on 2030-07-25.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8865690 | U-2942 | METHOD OF TREATING ACNE VULGARIS WITH TOPICALLY APPLIED CORTEXOLONE 17A-PROPIONATE | 2025-07-24 | 17alfa, 21-dihydroxypregnene esters as antiandrogenic agents |
DIAZEPAM - SPRAY;NASAL - VALTOCO
From NEURELIS INC; used for the acute treatment of intermittent seizure clusters
10MG/SPRAY
Approved in Jan 10, 2020, used as Reference Listed Drug and Reference Standard
5MG/SPRAY; 7.5MG/SPRAY
Approved in Jan 10, 2020, used as Reference Listed Drug
There are 4 future patent(s) for this application. The earliest expires on 2029-03-27, and the latest expires on 2029-03-27.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8927497 | U-2727 | NASAL ADMINISTRATION OF DIAZEPAM FOR TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY IN PATIENTS 6 YEARS OF AGE AND OLDER | 2025-07-21 | Absorption enhancers for intranasal administration |
| 8927497 | U-4173 | NASAL ADMINISTRATION OF DIAZEPAM FOR THE ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 2 YEARS OF AGE AND OLDER | 2025-07-21 | Absorption enhancers for intranasal administration |
FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - TRELEGY ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; used to treat COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema, and is also used 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 14 future patent(s) for this application. The earliest expires on 2025-11-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8183257 | 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 | 2025-07-27 | Muscarinic acetylcholine receptor antagonists |
IDELALISIB - TABLET;ORAL - ZYDELIG
From GILEAD SCIENCES INC; an antineoplastic kinase inhibitor used to treat chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL).
150MG
Approved in Jul 23, 2014, used as Reference Listed Drug and Reference Standard
100MG
Approved in Jul 23, 2014, used as Reference Listed Drug
There are 5 future patent(s) for this application. The earliest expires on 2025-08-05, and the latest expires on 2033-09-02.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| RE44599 | U-1615 | FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL | 2025-07-21 | Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta |
| RE44599 | U-1558 | FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA | 2025-07-21 | Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta |
LONAFARNIB - CAPSULE;ORAL - ZOKINVY
From SENTYNL THERAPEUTICS INC; a potent farnesyl transferase inhibitor used to reduce mortality associated with Hutchinson-Gilford progeria syndrome (HGPS) and other progeroid laminopathies.
75MG
Approved in Nov 20, 2020, used as Reference Listed Drug and Reference Standard
50MG
Approved in Nov 20, 2020, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2025-10-17, and the latest expires on 2025-10-17.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7838531 | U-3070 | REDUCING THE RISK OF MORTALITY IN HUTCHINSON-GILFORD PROGERIA SYNDROME (HGPS) | 2025-07-26 | Farnesyltransferase inhibitors for treatment of laminopathies, cellular aging and atherosclerosis |
OSPEMIFENE - TABLET;ORAL - OSPHENA
From DUCHESNAY INC; a non-hormonal estrogen receptor modulator (SERM) used to treat moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
60MG
Approved in Feb 26, 2013, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2026-08-11, and the latest expires on 2028-07-09.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 6245819 | U-1370 | TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE | 2025-07-21 | Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause |
| 6245819 | U-905 | TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE, SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE | 2025-07-21 | Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause |
UMECLIDINIUM BROMIDE - POWDER;INHALATION - INCRUSE ELLIPTA
From GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE; a long-acting muscarinic antagonist used as a long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
EQ 0.0625MG BASE/INH
Approved in Apr 30, 2014, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2027-10-02, and the latest expires on 2030-10-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8183257 | 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. | 2025-07-27 | Muscarinic acetylcholine receptor antagonists |
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - POWDER;INHALATION - ANORO ELLIPTA
From GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND; used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), 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 14 future patent(s) for this application. The earliest expires on 2025-11-21, and the latest expires on 2031-04-11.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8183257 | 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. | 2025-07-27 | Muscarinic acetylcholine receptor antagonists |
Exclusivities Expiring This Week
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 exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-27 | INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC) |
LUTETIUM LU 177 DOTATATE - SOLUTION;INTRAVENOUS - LUTATHERA
From ADVANCED ACCELERATOR APPLICATIONS USA INC; a radiolabeled somatostatin analog used to treat somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.
10mCi/ML
Approved in Jan 26, 2018, used as Reference Listed Drug and Reference Standard
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2027-04-23, and the latest expires on 2031-10-23.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-26 | PEDIATRIC EXCLUSIVITY |
REMDESIVIR - POWDER;INTRAVENOUS - VEKLURY
From GILEAD SCIENCES INC; a nucleoside analog used to treat RNA virus infections including COVID-19.
100MG/VIAL
Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-22, and the latest expires on 2027-01-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-21 | PEDIATRIC EXCLUSIVITY |
REMDESIVIR - SOLUTION;INTRAVENOUS - VEKLURY
From GILEAD SCIENCES INC; a nucleoside analog used to treat RNA virus infections including COVID-19.
100MG/20ML (5MG/ML)
Approved in Oct 22, 2020, used as Reference Listed Drug and Reference Standard
There are 5 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-22, and the latest expires on 2027-01-13.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-21 | PEDIATRIC EXCLUSIVITY |
TESTOSTERONE UNDECANOATE - CAPSULE;ORAL - KYZATREX
From MARIUS PHARMACEUTICALS LLC; to treat symptoms of low testosterone in men who have hypogonadism.
200MG
Approved in Jul 27, 2022, used as Reference Listed Drug and Reference Standard
100MG; 150MG
Approved in Jul 27, 2022, used as Reference Listed Drug
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-07-27 | NEW PRODUCT |
