Patent and Exclusivity Expirations Report

Report generated for the week of 2025-07-28 by Unibest Digital Center. Current analysis scope only include the US FDA.

Visit Unibest Licensing serivce and explore FDF assets open for global licensing and/or technology transfer. 

Visit Unibest intermediates and APIs for global supply.

Summary of Expirations

This week, there are 4 drugs in the patent and exclusivity list. They are:

• Livdelzi by Gilead Sciences, containing active ingredient Seladelpar Lysine

• Kybella by AbbVie, containing active ingredient Deoxycholic Acid

• Cotellic by Genentech, containing active ingredient Cobimetinib Fumarate

• Zoryve by Arcutis Biotherapeutics, containing active ingredient Roflumilast

Patents Expiring This Week

DEOXYCHOLIC ACID - SOLUTION;SUBCUTANEOUS - KYBELLA

From ABBVIE INC; a cytolytic agent injected subcutaneously to improve the appearance submental fat.

20MG/2ML (10MG/ML)

Approved in Apr 29, 2015, used as Reference Listed Drug and Reference Standard

There are 14 future patent(s) for this application. The earliest expires on 2027-12-10, and the latest expires on 2032-02-17.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8298556	U-1690	METHOD FOR REDUCTION OF SUBMENTAL FAT	2025-08-03	Methods and related compositions for the non-surgical removal of fat

SELADELPAR LYSINE - CAPSULE;ORAL - LIVDELZI

From GILEAD SCIENCES INC; a PPAR-delta agonist used to treat primary biliary cholangitis alone or in combination with ursodeoxycholic acid in adults.

EQ 10MG BASE

Approved in Aug 14, 2024, used as Reference Listed Drug and Reference Standard

There are 5 future patent(s) for this application. The earliest expires on 2026-09-13, and the latest expires on 2035-03-19.

Patent No	Patent Expiration Date	Patent Title
7301050	2025-08-02	4-((phenoxyalkyl)thio)-phenoxyacetic acids and analogs

Exclusivities Expiring This Week

COBIMETINIB FUMARATE - TABLET;ORAL - COTELLIC

From GENENTECH INC; an antineoplastic agent and selective inhibitor of the mitogen-activated extracellular kinase (MEK) pathway used to treat unresectable or metastatic melanoma.

EQ 20MG BASE

Approved in Nov 10, 2015, used as Reference Listed Drug and Reference Standard

There are 3 future exclusivity(ies) for this drug product. The earliest expires on 2025-10-28, and the latest expires on 2029-10-28.

Exclusivity Date	Exclusivity Use Definition
2025-07-28	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665

ROFLUMILAST - CREAM;TOPICAL - ZORYVE

From ARCUTIS BIOTHERAPEUTICS INC; a selective phosphodiesterase-4 inhibitor indicated to decrease the risk of exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) and to treat skin conditions such as plaque psoriasis and atopic dermatitis.

0.3%

Approved in Jul 29, 2022, used as Reference Listed Drug and Reference Standard

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2026-10-05, and the latest expires on 2027-07-09.

Exclusivity Date	Exclusivity Use Definition
2025-07-29	NEW PRODUCT