Patent and Exclusivity Expirations Report

Report generated for the week of 2025-02-03 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 4 drugs in the patent and exclusivity list. They are:
- BRISTOL MYERS SQUIBB CO's SPRYCEL, containing active ingredient DASATINIB
- AMERICAN REGENT INC's INJECTAFER, containing active ingredient FERRIC CARBOXYMALTOSE
- ABBVIE INC's KYBELLA, containing active ingredient DEOXYCHOLIC ACID
- MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC's ZOLINZA, containing active ingredient VORINOSTAT

Patents Expiring This Week

DASATINIB - TABLET;ORAL - SPRYCEL

From BRISTOL MYERS SQUIBB CO; for treating Philadelphia chromosome-positive acute lymphoblastic leukemia or chronic myeloid leukemia.

20MG; 50MG; 70MG

Approved in Jun 28, 2006, used as Reference Listed Drug

100MG

Approved in May 30, 2008, used as Reference Listed Drug and Reference Standard

140MG; 80MG

Approved in Oct 28, 2010, used as Reference Listed Drug

There are 3 future patent(s) for this application. The earliest expires on 2025-08-04, and the latest expires on 2026-09-28.

Patent No	Patent Expiration Date	Patent Title
8680103	2025-02-04	Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors

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 2025-08-03, and the latest expires on 2030-03-02.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8846066	U-1690	METHOD FOR REDUCTION OF SUBMENTAL FAT	2025-02-08	Methods and related compositions for reduction of fat and skin tightening

FERRIC CARBOXYMALTOSE - SOLUTION;INTRAVENOUS - INJECTAFER

From AMERICAN REGENT INC; an iron replacement therapy used to treat iron deficiency anemia in children and adults with intolerance or inadequate clinical response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease.

750MG IRON/15ML (50MG IRON/ML)

Approved in Jul 25, 2013, used as Reference Listed Drug and Reference Standard

500MG IRON/10ML (50MG IRON/ML)

Approved in Oct 8, 2020, used as Reference Listed Drug and Reference Standard

1GM IRON/20ML (50MG IRON/ML)

Approved in Apr 28, 2021, used as Reference Listed Drug and Reference Standard

100MG IRON/2ML (50MG IRON/ML)

Approved in Feb 4, 2022, used as Reference Listed Drug and Reference Standard

In the issue of 2024-11-18, the exclusivity of NEW PATIENT POPULATION for Injectafer has expired. 

There are 5 future patent(s) for this application. The earliest expires on 2027-01-08, and the latest expires on 2028-02-15.

Patent No	Patent Expiration Date	Patent Title
7612109	2025-02-05	Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes

VORINOSTAT - CAPSULE;ORAL - ZOLINZA

From MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC; for the treatment of cutaneous manifestations in patients with progressive, persistent, or recurrent cutaneous T- cell lymphoma (CTCL) following prior systemic therapies.

100MG

Approved in Oct 6, 2006, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2026-05-16, and the latest expires on 2028-03-18.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7399787	U-892	TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)	2025-02-09	Methods of treating cancer with HDAC inhibitors

Exclusivities Expiring This Week

No expirations this week.