Patent and Exclusivity Expirations Report
Report generated for the week of 2025-08-18 by Unibest Digital Center. Current analysis scope only include the US FDA.
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Summary of Expirations
This week, there are 10 drugs in the patent and exclusivity list. They are:
Ogsiveo by SpringWorks Therapeutics, containing active ingredient Nirogacestat Hydrobromide
Genosyl by Vero Biotech, containing active ingredient Nitric Oxide
Onzetra Xsail by Currax Pharmaceuticals, containing active ingredient Sumatriptan Succinate
Qoliana by Sandoz, containing active ingredient Brimonidine Tartrate
Tyvaso DPI by United Therapeutics, containing active ingredient Treprostinil
Acetadote by Cumberland Pharmaceuticals, containing active ingredient Acetylcysteine
Auvelity by Axsome Therapeutics, containing active ingredient Bupropion Hydrochloride; Dextromethorphan Hydrobromide
Diacomit by Biocodex, containing active ingredient Stiripentol
Imbruvica by Pharmacyclics, containing active ingredient Ibrutinib
Jardiance by Boehringer Ingelheim, containing active ingredient Empagliflozin
Patents Expiring This Week
ACETYLCYSTEINE - INJECTABLE;INTRAVENOUS - ACETADOTE
From CUMBERLAND PHARMACEUTICALS INC; used to treat acetaminophen overdose.
6GM/30ML (200MG/ML)
Approved in Jan 23, 2004, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2026-05-21, and the latest expires on 2032-04-06.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8653061 | U-1373 | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | 2025-08-24 | Acetylcysteine composition and uses thereof |
| 8399445 | U-1373 | METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS | 2025-08-24 | Acetylcysteine composition and uses thereof |
BRIMONIDINE TARTRATE - SOLUTION/DROPS;OPHTHALMIC - QOLIANA
From SANDOZ INC; an alpha-2 adrenergic agonist used to treat glaucoma and ocular hypertension, as well as facial erythema in rosacea.
0.15%
Approved in May 22, 2006, used as Reference Listed Drug and Reference Standard
There are no future patents for this application.
| Patent No | Patent Expiration Date | Patent Title |
| 7265117 | 2025-08-19 | Topical brimonidine tartrate formulations that lack chlorine dioxide |
NIROGACESTAT HYDROBROMIDE - TABLET;ORAL - OGSIVEO
From SPRINGWORKS THERAPEUTICS INC; an oral, selective, gamma-secretase inhibitor that may be used to treat adults with progressing desmoid tumors who require systemic treatment.
EQ 150MG BASE
Approved in Apr 4, 2024, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE
Approved in Nov 27, 2023, used as Reference Listed Drug
EQ 100MG BASE
Approved in Apr 4, 2024, used as Reference Listed Drug
There are 27 future patent(s) for this application. The earliest expires on 2026-03-11, and the latest expires on 2043-05-19.
| Patent No | Patent Expiration Date | Patent Title |
| 7795447 | 2025-08-18 | Imidazole compounds for the treatment of neurodegenerative disorders |
| 7342118 | 2025-08-18 | Imidazole compounds for the treatment of neurodegenerative disorders |
NITRIC OXIDE - GAS;INHALATION - GENOSYL
From VERO BIOTECH INC; used together with a breathing machine (ventilator) and other agents to treat newborn (term and near-term) babies with respiratory failure that is caused by pulmonary hypertension.
800PPM
Approved in Dec 20, 2019, used as Reference Listed Drug and Reference Standard
There are 15 future patent(s) for this application. The earliest expires on 2025-10-17, and the latest expires on 2040-07-22.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 10124142 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 8609028 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 11383059 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 11291793 |
|
| 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 8821801 |
|
| 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 9956373 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 11554241 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 8226916 | U-3037 | A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT | 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
| 9522249 |
|
| 2025-08-18 | Conversion of nitrogen dioxide (NO2) to nitric oxide (NO) |
SUMATRIPTAN SUCCINATE - POWDER;NASAL - ONZETRA XSAIL
From CURRAX PHARMACEUTICALS LLC; used to treat migraine headaches.
EQ 11MG BASE
Approved in Jan 27, 2016, used as Reference Listed Drug and Reference Standard
There are 14 future patent(s) for this application. The earliest expires on 2025-09-15, and the latest expires on 2034-10-20.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7975690 | U-1809 | METHOD OF DRUG DELIVERY VIA THE NASAL CAVITY | 2025-08-18 | Nasal devices |
TREPROSTINIL - POWDER;INHALATION - TYVASO DPI
From UNITED THERAPEUTICS CORP; used to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in adults.
0.08MG/INH
Approved in Oct 24, 2024, used as Reference Listed Drug and Reference Standard
0.016MG/INH; 0.032MG/INH; 0.048MG/INH; 0.064MG/INH
Approved in May 23, 2022, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2027-05-14, and the latest expires on 2042-02-03.
| Patent No | Patent Expiration Date | Patent Title |
| 10130685 | 2025-08-23 | Diketopiperazine salts for drug delivery and related methods |
Exclusivities Expiring This Week
BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE - TABLET, EXTENDED RELEASE;ORAL - AUVELITY
From AXSOME THERAPEUTICS INC; an antidepressant medicine used to treat Major Depressive Disorder (MDD).
105MG;45MG
Approved in Aug 18, 2022, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-18 | NEW PRODUCT |
EMPAGLIFLOZIN - TABLET;ORAL - JARDIANCE
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; used to help control blood sugar levels in type 2 diabetes and is also used to reduce the risk of cardiovascular problems in adults with heart failure or cardiovascular disease with type 2 diabetes.
10MG
Approved in Aug 1, 2014, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-06-20, and the latest expires on 2026-12-20.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-24 | PEDIATRIC EXCLUSIVITY |
IBRUTINIB - CAPSULE;ORAL - IMBRUVICA
From PHARMACYCLICS LLC; a targeted therapy used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) in certain patients. Imbruvica helps slow cancer progression in CLL, SLL, and WM and slow disease progression in cGVHD.
140MG
Approved in Nov 13, 2013, used as Reference Listed Drug and Reference Standard
70MG
Approved in Dec 20, 2017, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-02-24, and the latest expires on 2030-02-24.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-24 | NEW PATIENT POPULATION |
| 2025-08-24 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
IBRUTINIB - SUSPENSION;ORAL - IMBRUVICA
From PHARMACYCLICS LLC; a targeted therapy used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) in certain patients. Imbruvica helps slow cancer progression in CLL, SLL, and WM and slow disease progression in cGVHD.
70MG/ML
Approved in Aug 24, 2022, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-02-24, and the latest expires on 2030-02-24.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-24 | NEW PRODUCT |
IBRUTINIB - TABLET;ORAL - IMBRUVICA
From PHARMACYCLICS LLC; a targeted therapy used to treat chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) in certain patients. Imbruvica helps slow cancer progression in CLL, SLL, and WM and slow disease progression in cGVHD.
420MG
Approved in Feb 16, 2018, used as Reference Listed Drug and Reference Standard
140MG; 280MG
Approved in Feb 16, 2018, used as Reference Listed Drug
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2026-02-24, and the latest expires on 2030-02-24.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-24 | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION |
| 2025-08-24 | NEW PATIENT POPULATION |
STIRIPENTOL - CAPSULE;ORAL - DIACOMIT
From BIOCODEX SA; used to treat seizures associated with Dravet syndrome.
250MG
Approved in Aug 20, 2018, used as Reference Listed Drug
500MG
Approved in Aug 20, 2018, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-07-14, and the latest expires on 2029-07-14.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-20 | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM |
STIRIPENTOL - FOR SUSPENSION;ORAL - DIACOMIT
From BIOCODEX SA; used to treat seizures associated with Dravet syndrome.
500MG/PACKET
Approved in Aug 20, 2018, used as Reference Listed Drug and Reference Standard
250MG/PACKET
Approved in Aug 20, 2018, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-07-14, and the latest expires on 2029-07-14.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-08-20 | INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME (DS) IN PATIENTS 2 YEARS OF AGE AND OLDER TAKING CLOBAZAM |
