Patent and Exclusivity Expirations Report

Report generated for the week of 2025-02-17 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 7 drugs in the patent and exclusivity list. They are:
- DURYSTA by AbbVie Inc, containing active ingredient Bimatoprost
- IXEMPRA KIT by R-Pharm US LLC, containing active ingredient Ixabepilone
- XIFAXAN by Salix Pharmaceuticals Inc, containing active ingredient Rifaximin
- DIFFERIN by Galderma Laboratories LP, containing active ingredient Adapalene
- NEXLIZET by Esperion Therapeutics Inc, containing active ingredient Bempedoic Acid; Ezetimibe
- NEXLETOL by Esperion Therapeutics Inc, containing active ingredient Bempedoic Acid
- XARELTO by Janssen Pharmaceuticals Inc, containing active ingredient Rivaroxaban

Patents Expiring This Week

ADAPALENE - GEL;TOPICAL - DIFFERIN

From GALDERMA LABORATORIES LP; a third-generation topical retinoid with anti-comedogenic, comedolytic, and anti-inflammatory properties used to treat acne vulgaris in adolescents and adults.

0.3%

Approved in Jun 19, 2007, 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
7579377	U-818	Topical treatment of acne vulgaris	2025-02-23	Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders

BIMATOPROST - IMPLANT;OPHTHALMIC - DURYSTA

From ABBVIE INC; a prostaglandin analog used to treat hypotrichosis of the eyelashes and intraocular pressure in open angle glaucoma or ocular hypertension.

10MCG

Approved in Mar 4, 2020, used as Reference Listed Drug and Reference Standard

There are 7 future patent(s) for this application. The earliest expires on 2026-12-19, and the latest expires on 2034-10-31.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8673341	U-2759	Reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant	2025-02-19	Intraocular pressure reduction with intracameral bimatoprost implants

IXABEPILONE - INJECTABLE;INTRAVENOUS - IXEMPRA KIT

From R-PHARM US LLC;  a microtubule inhibitor administered in combination with capecitabine or alone in the treatment of metastatic or locally advanced breast cancer that has shown inadequate response to taxanes and anthracyclines.

15MG/VIAL; 45MG/VIAL

Approved in Oct 16, 2007, used as Reference Listed Drug and Reference Standard

There are no future patents for this application.

Patent No	Patent Expiration Date	Patent Title
7312237*PED	2025-02-21	Combination of epothilone analogs and chemotherapeutic agents for the treatment of prolilferative diseases

RIFAXIMIN - TABLET;ORAL - XIFAXAN

From SALIX PHARMACEUTICALS INC; for the treatment of patients (≥12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli; for the reduction of overt hepatic encephalopathy recurrence in patients ≥18 years of age; and in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women.

550MG

Approved in Mar 24, 2010, used as Reference Listed Drug and Reference Standard

There are 21 future patent(s) for this application. The earliest expires on 2025-06-01, and the latest expires on 2029-10-02.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7915275	U-1708	Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.	2025-02-23	Use of polymorphic forms of rifaximin for medical preparations
7915275	U-1707	Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and symptoms thereof.	2025-02-23	Use of polymorphic forms of rifaximin for medical preparations

Exclusivities Expiring This Week

BEMPEDOIC ACID - TABLET;ORAL - NEXLETOL

From ESPERION THERAPEUTICS INC; used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia.

180MG

Approved in Feb 21, 2020, used as Reference Listed Drug and Reference Standard

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-03-22, and the latest expires on 2027-03-22.

Exclusivity Date	Exclusivity Use Definition
2025-02-21	New Chemical Entity

BEMPEDOIC ACID; EZETIMIBE - TABLET;ORAL - NEXLIZET

From ESPERION THERAPEUTICS INC; used to reduce LDL-C levels in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), alone or in combination with other LDL-C lowering therapies.

180MG;10MG

Approved in Feb 26, 2020, used as Reference Listed Drug and Reference Standard

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2027-03-22, and the latest expires on 2027-03-22.

Exclusivity Date	Exclusivity Use Definition
2025-02-21	New Chemical Entity

RIVAROXABAN - TABLET;ORAL - XARELTO

From JANSSEN PHARMACEUTICALS INC; a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). May also be used as thrombosis prophylaxis in specific situations.

10MG; 2.5MG; 15MG

Approved in Jul 1, 2011, used as Reference Listed Drug

20MG

Approved in Nov 4, 2011, used as Reference Listed Drug and Reference Standard

In previous issues of 2024-11-11 and 2024-12-16, Xarelto's patent of its use in prophylaxis of venous thromboembolism, deep vein thrombosis and thromboembolic diseases, as well as the exclusivity of New Product has expired. 

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-02-23	Pediatric Exclusivity