Patent and Exclusivity Expirations Report
Report generated for the week of 2025-04-28 by Unibest Digital Center. Current analysis scope only include the US FDA.
Summary of Expirations
This week, there are 16 drugs in the patent and exclusivity list. They are:
INLYTA by PF PRISM CV, containing active ingredient AXITINIB
AUVI-Q by KALEO INC, containing active ingredient EPINEPHRINE
BRILINTA by ASTRAZENECA PHARMACEUTICALS LP, containing active ingredient TICAGRELOR
ONIVYDE by IPSEN BIOPHARMACEUTICALS INC, containing active ingredient IRINOTECAN HYDROCHLORIDE
JENTADUETO by BOEHRINGER INGELHEIM PHARMACEUTICALS INC, containing active ingredient LINAGLIPTIN; METFORMIN HYDROCHLORIDE
GLYXAMBI by BOEHRINGER INGELHEIM, containing active ingredient EMPAGLIFLOZIN; LINAGLIPTIN
TRIJARDY XR by BOEHRINGER INGELHEIM PHARMACEUTICALS INC, containing active ingredient EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
TRADJENTA by BOEHRINGER INGELHEIM PHARMACEUTICALS INC, containing active ingredient LINAGLIPTIN
JENTADUETO XR by BOEHRINGER INGELHEIM PHARMACEUTICALS INC, containing active ingredient LINAGLIPTIN; METFORMIN HYDROCHLORIDE
BRISDELLE by LEGACY PHARMA INC, containing active ingredient PAROXETINE MESYLATE
CUVRIOR by ORPHALAN SA, containing active ingredient TRIENTINE TETRAHYDROCHLORIDE
RINVOQ by ABBVIE INC, containing active ingredient UPADACITINIB
QELBREE by SUPERNUS PHARMACEUTICALS INC, containing active ingredient VILOXAZINE HYDROCHLORIDE
MEKINIST by NOVARTIS PHARMACEUTICALS CORP, containing active ingredient TRAMETINIB DIMETHYL SULFOXIDE
TAFINLAR by NOVARTIS PHARMACEUTICALS CORP, containing active ingredient DABRAFENIB MESYLATE
EMEND by MERCK AND CO INC, containing active ingredient FOSAPREPITANT DIMEGLUMINE
Patents Expiring This Week
AXITINIB - TABLET;ORAL - INLYTA
From PF PRISM CV; for the treatment of advanced renal cell carcinoma.
1MG
Approved in Jan 27, 2012, used as Reference Listed Drug
5MG
Approved in Jan 27, 2012, used as Reference Listed Drug and Reference Standard
There are 7 future patent(s) for this application. The earliest expires on 2025-10-29, and the latest expires on 2037-07-12.
| Patent No | Patent Expiration Date | Patent Title |
| 6534524 | 2025-04-29 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use |
EMPAGLIFLOZIN; LINAGLIPTIN - TABLET;ORAL - GLYXAMBI
From BOEHRINGER INGELHEIM; for the treatment of type 2 diabetes mellitus.
10MG;5MG
Approved in Jan 30, 2015, used as Reference Listed Drug
25MG;5MG
Approved in Jan 30, 2015, used as Reference Listed Drug and Reference Standard
There are 22 future patent(s) for this application. The earliest expires on 2025-11-02, and the latest expires on 2034-10-03.
| Patent No | Patent Expiration Date | Patent Title |
| 7407955 | 2025-05-02 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - TRIJARDY XR
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; for the treatment of type 2 diabetes mellitus.
25MG;5MG;1GM
Approved in Jan 27, 2020, used as Reference Listed Drug and Reference Standard
5MG;2.5MG;1GM
10MG;5MG;1GM
12.5MG;2.5MG;1GM
Approved in Jan 27, 2020, used as Reference Listed Drug
There are 23 future patent(s) for this application. The earliest expires on 2025-11-02, and the latest expires on 2034-12-11.
| Patent No | Patent Expiration Date | Patent Title |
| 7407955 | 2025-05-02 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
EPINEPHRINE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - AUVI-Q
From KALEO INC; for the treatment of allergic reactions to insect stings or bites, foods, drus, and other allergens.
EQ 0.15MG/DELIVERY
Approved in Aug 10, 2012, used as Reference Listed Drug and Reference Standard
EQ 0.3MG/DELIVERY
Approved in Aug 10, 2012, used as Reference Listed Drug
EQ 0.1MG/DELIVERY
Approved in Nov 17, 2017, used as Reference Listed Drug
There are 9 future patent(s) for this application. The earliest expires on 2026-12-12, and the latest expires on 2037-12-21.
| Patent No | Patent Expiration Date | Patent Title |
| 10335549 | 2025-04-30 | Devices, systems and methods for medicament delivery |
IRINOTECAN HYDROCHLORIDE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - ONIVYDE
From IPSEN BIOPHARMACEUTICALS INC; for the treatment of metastatic pancreatic cancer.
EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
Approved in Oct 22, 2015, used as Reference Listed Drug and Reference Standard
There are 13 future patent(s) for this application. The earliest expires on 2027-01-06, and the latest expires on 2036-10-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9724303 |
|
| 2025-05-02 | Liposomes useful for drug delivery |
| 8992970 |
|
| 2025-05-02 | Liposomes useful for drug delivery |
| 8703181 | U-1434 | TREATMENT OF PANCREATIC CANCER | 2025-05-02 | Liposomes useful for drug delivery |
| 9730891 | U-1848 | TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN | 2025-05-02 | Liposomes useful for drug delivery |
| 9782349 |
|
| 2025-05-02 | Liposomes useful for drug delivery |
| 10722508 |
|
| 2025-05-02 | Liposomes useful for drug delivery |
LINAGLIPTIN - TABLET;ORAL - TRADJENTA
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; for the treatment of type 2 diabetes mellitus.
5MG
Approved in May 2, 2011, used as Reference Listed Drug and Reference Standard
There are 17 future patent(s) for this application. The earliest expires on 2025-11-02, and the latest expires on 2031-09-05.
| Patent No | Patent Expiration Date | Patent Title |
| 7407955 | 2025-05-02 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TABLET, EXTENDED RELEASE;ORAL - JENTADUETO XR
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; for the treatment of type 2 diabetes mellitus.
2.5MG;1GM
Approved in May 27, 2016, used as Reference Listed Drug
5MG;1GM
Approved in May 27, 2016, used as Reference Listed Drug and Reference Standard
There are 16 future patent(s) for this application. The earliest expires on 2025-11-02, and the latest expires on 2033-09-06.
| Patent No | Patent Expiration Date | Patent Title |
| 7407955 | 2025-05-02 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TABLET;ORAL - JENTADUETO
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; for the treatment of type 2 diabetes mellitus.
2.5MG;1GM
Approved in Jan 30, 2012, used as Reference Listed Drug and Reference Standard
2.5MG;500MG
2.5MG;850MG
Approved in Jan 30, 2012, used as Reference Listed Drug
There are 16 future patent(s) for this application. The earliest expires on 2025-11-02, and the latest expires on 2030-12-04.
| Patent No | Patent Expiration Date | Patent Title |
| 7407955 | 2025-05-02 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
PAROXETINE MESYLATE - CAPSULE;ORAL - BRISDELLE
From LEGACY PHARMA INC; to reduce moderate to severe hot flashes related to menopause.
EQ 7.5MG BASE
Approved in Jun 28, 2013, used as Reference Listed Drug and Reference Standard
There are 3 future patent(s) for this application. The earliest expires on 2026-08-04, and the latest expires on 2029-04-06.
| Patent No | Patent Expiration Date | Patent Title |
| 7598271 | 2025-05-04 | Crystalline paroxetine methane sulfonate |
TICAGRELOR - TABLET;ORAL - BRILINTA
From ASTRAZENECA PHARMACEUTICALS LP; to lower the rate of cardiovascular events such as heart attack and stroke in patients who are at a risk.
60MG
Approved in Sep 3, 2015, used as Reference Listed Drug
90MG
Approved in Jul 20, 2011, used as Reference Listed Drug and Reference Standard
There are 4 future patent(s) for this application. The earliest expires on 2030-04-17, and the latest expires on 2036-07-27.
| Patent No | Patent Expiration Date | Patent Title |
| RE46276*PED | 2025-04-30 | Triazolo(4,5-D)pyrimidine compounds |
Exclusivities Expiring This Week
DABRAFENIB MESYLATE - CAPSULE;ORAL - TAFINLAR
From NOVARTIS PHARMACEUTICALS CORP; for the treatment of patients with specific types of melanoma, NSCLC, and thyroid cancer.
EQ 75MG BASE
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
EQ 50MG BASE
Approved in May 29, 2013, used as Reference Listed Drug
There are 8 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-30 | TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION |
| 2025-05-04 | TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
FOSAPREPITANT DIMEGLUMINE - POWDER;INTRAVENOUS - EMEND
From MERCK AND CO INC; for preventing nausea and vomiting caused by chemotherapy.
EQ 150MG BASE/VIAL
Approved in Nov 12, 2010, used as Reference Listed Drug and Reference Standard
There are no future exclusivities for this application.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-05-02 | ADDITION OF A 3-DAY FOSAPREPITANT FOR INJECTION INTRAVENOUS DOSING REGIMEN IN PEDIATRIC PATIENTS FOR THE CURRENTLY APPROVED PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING |
TRAMETINIB DIMETHYL SULFOXIDE - TABLET;ORAL - MEKINIST
From NOVARTIS PHARMACEUTICALS CORP; for the treatment of patients with cancers with specific BRAF mutations, such as melanoma and NSCLC.
EQ 0.5MG
Approved in May 29, 2013, used as Reference Listed Drug
EQ 2MG
Approved in May 29, 2013, used as Reference Listed Drug and Reference Standard
There are 8 future exclusivity(ies) for this drug product. The earliest expires on 2025-06-22, and the latest expires on 2030-09-16.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-30 | TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION |
| 2025-05-04 | TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS |
TRIENTINE TETRAHYDROCHLORIDE - TABLET;ORAL - CUVRIOR
From ORPHALAN SA; a copper chelating agent for the management of Wilson's disease in cases where penicillamine therapy is clinically inappropriate.
300MG
Approved in Apr 28, 2022, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2029-04-28, and the latest expires on 2029-04-28.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-28 | NEW PRODUCT |
UPADACITINIB - TABLET, EXTENDED RELEASE;ORAL - RINVOQ
From ABBVIE INC; for the treatment of moderate to severe rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and severe atopic dermatitis, including in patients who did not respond will to other therapies.
15MG
Approved in Aug 16, 2019, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2026-05-18, and the latest expires on 2031-04-26.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-29 | TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS |
VILOXAZINE HYDROCHLORIDE - CAPSULE, EXTENDED RELEASE;ORAL - QELBREE
From SUPERNUS PHARMACEUTICALS INC; for the treatment of ADHD.
EQ 200MG BASE
Approved in Apr 2, 2021, used as Reference Listed Drug and Reference Standard
EQ 100MG BASE; EQ 150MG BASE
Approved in Apr 2, 2021, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-04-02, and the latest expires on 2026-04-02.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-04-29 | NEW PATIENT POPULATION |
