Patent and Exclusivity Expirations Report
Report generated for the week of 2025-09-01 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:
Amitiza by Sucampo Pharma Americas LLC, containing active ingredient Lubiprostone
Erivedge by Genentech Inc, containing active ingredient Vismodegib
Vizamyl by GE Healthcare, containing active ingredient Flutemetamol F-18
Qutenza by Averitas Pharma Inc, containing active ingredient Capsaicin
Pradaxa by Boehringer Ingelheim Pharmaceuticals Inc, containing active ingredient Dabigatran Etexilate Mesylate
Kerendia by Bayer Healthcare Pharmaceuticals Inc, containing active ingredient Finerenone
Orkambi by Vertex Pharmaceuticals Inc, containing active ingredient Ivacaftor; Lumacaftor
Detectnet by Curium US LLC, containing active ingredient Copper Cu-64 Dotatate
Gavreto by Rigel Pharmaceuticals Inc, containing active ingredient Pralsetinib
Cresemba by Astellas Pharma US Inc, containing active ingredient Isavuconazonium Sulfate
Patents Expiring This Week
CAPSAICIN - PATCH;TOPICAL - QUTENZA
From AVERITAS PHARMA INC; used to treat postherpetic neuralgia (PHN) or nerve pain of the feet caused by diabetic peripheral neuropathy (DPN).
8%
Approved in Nov 16, 2009, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2028-12-15, and the latest expires on 2030-03-26.
| Patent No | Patent Expiration Date | Patent Title |
| 10034841 | 2025-09-06 | Transdermal therapeutic system comprising an adhesive layer method for siliconizing the back layer of the system and use of said back layer |
DABIGATRAN ETEXILATE MESYLATE - CAPSULE;ORAL - PRADAXA
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; an anticoagulant used for the prevention of venous thromboembolic events or stroke in patients with recent elective hip or knee replacement surgery and atrial fibrillation.
EQ 150MG BASE
Approved in Oct 19, 2010, used as Reference Listed Drug and Reference Standard
EQ 75MG BASE
Approved in Oct 19, 2010, used as Reference Listed Drug
EQ 110MG BASE
Approved in Nov 20, 2015, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2026-03-07, and the latest expires on 2031-07-20.
| Patent No | Patent Expiration Date | Patent Title |
| 7932273 | 2025-09-07 | 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament |
DABIGATRAN ETEXILATE MESYLATE - PELLETS;ORAL - PRADAXA
From BOEHRINGER INGELHEIM PHARMACEUTICALS INC; an anticoagulant used for the prevention of venous thromboembolic events or stroke in patients with recent elective hip or knee replacement surgery and atrial fibrillation.
EQ 150MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug and Reference Standard
EQ 20MG BASE/PACKET; EQ 30MG BASE/PACKET; EQ 40MG BASE/PACKET; EQ 50MG BASE/PACKET; EQ 110MG BASE/PACKET
Approved in Jun 21, 2021, used as Reference Listed Drug
There are 1 future patent(s) for this application. The earliest expires on 2026-03-07, and the latest expires on 2026-03-07.
| Patent No | Patent Expiration Date | Patent Title |
| 7932273 | 2025-09-07 | 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament |
FLUTEMETAMOL F-18 - INJECTABLE;INTRAVENOUS - VIZAMYL
From GE HEALTHCARE; a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer's disease (AD), other causes of cognitive decline, or in a selection of patients suitable for amyloid beta-directed treatment
121.5mCi/30ML (4.05mCi/ML)
Approved in Oct 25, 2013, used as Reference Listed Drug and Reference Standard
There are 1 future patent(s) for this application. The earliest expires on 2028-09-16, and the latest expires on 2028-09-16.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 7270800 | U-336 | DIAGNOSTIC RADIOIMAGING | 2025-09-03 | Thioflavin derivatives for use in antemortem diagnosis of Alzheimer's disease and in vivo imaging and prevention of amyloid deposition |
LUBIPROSTONE - CAPSULE;ORAL - AMITIZA
From SUCAMPO PHARMA AMERICAS LLC; a prostaglandin derivative used to treat constipation caused by irritable bowel syndrome and opioid-use.
24MCG
Approved in Jan 31, 2006, used as Reference Listed Drug and Reference Standard
8MCG
Approved in Apr 29, 2008, used as Reference Listed Drug
There are 3 future patent(s) for this application. The earliest expires on 2027-01-23, and the latest expires on 2027-10-25.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 8748481 | U-1520 | METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT | 2025-09-01 | Method for treating gastrointestinal disorder |
VISMODEGIB - CAPSULE;ORAL - ERIVEDGE
From GENENTECH INC; a hedgehog pathway inhibitor used to treat patients with locally advanced or metastatic basal cell carcinoma.
150MG
Approved in Jan 30, 2012, used as Reference Listed Drug and Reference Standard
There are 2 future patent(s) for this application. The earliest expires on 2028-11-11, and the latest expires on 2028-12-15.
| Patent No | Patent Use Code | Patent Use Definition | Patent Expiration Date | Patent Title |
| 9790183 | U-3109 | METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA | 2025-09-02 | Pyridyl inhibitors of hedgehog signalling |
Exclusivities Expiring This Week
COPPER CU-64 DOTATATE - SOLUTION;INTRAVENOUS - DETECTNET
From CURIUM US LLC; a Cu labeled somatostatin analog used in positron emission tomography to detect certain types of neuroendocrine tumors.
4mL (1mCi/ML)
Approved in Sep 3, 2020, used as Reference Listed Drug and Reference Standard
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-03, and the latest expires on 2027-09-03.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-03 | NEW CHEMICAL ENTITY |
FINERENONE - TABLET;ORAL - KERENDIA
From BAYER HEALTHCARE PHARMACEUTICALS INC; a nonsteroidal mineralocorticoid receptor antagonist indicated to lower the risk of eGFR decline, end stage kidney disease, cardiovascular death, heart attack, and hospitalization for heart failure in chronic kidney disease associated with type 2 diabetes.
20MG
Approved in Jul 9, 2021, used as Reference Listed Drug and Reference Standard
10MG
Approved in Jul 9, 2021, used as Reference Listed Drug
There are 1 future exclusivity(ies) for this drug product. The earliest expires on 2026-07-09, and the latest expires on 2026-07-09.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-01 | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF FIGARO-DKD STUDY |
ISAVUCONAZONIUM SULFATE - CAPSULE;ORAL - CRESEMBA
From ASTELLAS PHARMA US INC; an antifungal medication that may be used to treat invasive fungal infections caused by aspergillosis or mucormycosis
186MG
Approved in Mar 6, 2015, used as Reference Listed Drug and Reference Standard
74.5MG
Approved in Nov 22, 2022, used as Reference Listed Drug
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2026-12-08, and the latest expires on 2031-06-08.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-06 | GENERATING ANTIBIOTIC INCENTIVES NOW |
ISAVUCONAZONIUM SULFATE - POWDER;INTRAVENOUS - CRESEMBA
From ASTELLAS PHARMA US INC; an antifungal medication that may be used to treat invasive fungal infections caused by aspergillosis or mucormycosis
372MG
Approved in Mar 6, 2015, used as Reference Listed Drug and Reference Standard
There are 6 future exclusivity(ies) for this drug product. The earliest expires on 2026-12-08, and the latest expires on 2031-06-08.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-06 | GENERATING ANTIBIOTIC INCENTIVES NOW |
IVACAFTOR; LUMACAFTOR - GRANULE;ORAL - ORKAMBI
From VERTEX PHARMACEUTICALS INC; used to treat certain types of cystic fibrosis.
188MG/PACKET;150MG/PACKET
Approved in Aug 7, 2018, used as Reference Listed Drug and Reference Standard
125MG/PACKET;100MG/PACKET
Approved in Aug 7, 2018, used as Reference Listed Drug
94MG/PACKET;75MG/PACKET
Approved in Sep 2, 2022, used as Reference Listed Drug
There are 4 future exclusivity(ies) for this drug product. The earliest expires on 2027-12-13, and the latest expires on 2030-03-02.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-02 | NEW STRENGTH |
PRALSETINIB - CAPSULE;ORAL - GAVRETO
From RIGEL PHARMACEUTICALS INC; a RET receptor tyrosine kinase inhibitor for the treatment of metastatic RET-driven non-small cell lung cancer.
100MG
Approved in Sep 4, 2020, used as Reference Listed Drug and Reference Standard
There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2027-09-04, and the latest expires on 2027-12-01.
| Exclusivity Date | Exclusivity Use Definition |
| 2025-09-04 | NEW CHEMICAL ENTITY |
