Patent and Exclusivity Expirations Report

Report generated for the week of 2025-06-02 by Unibest Digital Center. Current analysis scope only include the US FDA.

Summary of Expirations

This week, there are 5 drugs in the patent and exclusivity list. They are:

• Nuzyra by Paratek Pharmaceuticals, containing active ingredient Omadacycline Tosylate

• Ciprodex by Sandoz, containing active ingredient Ciprofloxacin and Dexamethasone

• Brixadi by Braeburn, containing active ingredient Buprenorphine

• Arikayce Kit by Insmed, containing active ingredient Amikacin Sulfate

• Venclexta by AbbVie, containing active ingredient Venetoclax

Patents Expiring This Week

AMIKACIN SULFATE - SUSPENSION, LIPOSOMAL;INHALATION - ARIKAYCE KIT

From INSMED INC; an aminoglycoside used to treat infections caused by more resistant strains of Gram negative bacteria and some Gram positive bacteria.

EQ 590MG BASE/8.4ML

Approved in Sep 28, 2018, used as Reference Listed Drug and Reference Standard

There are 12 future patent(s) for this application. The earliest expires on 2026-12-05, and the latest expires on 2035-05-15.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
7718189	U-2415	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN	2025-06-06	Sustained release of antiinfectives

BUPRENORPHINE - SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS - BRIXADI

From BRAEBURN INC; a partial opioid agonist used for management of severe pain that is not responsive to alternative treatments. Also used for maintenance treatment of opioid addiction.

128MG/0.36ML (356MG/ML)

Approved in May 23, 2023, used as Reference Listed Drug and Reference Standard

8MG/0.16ML (50MG/ML); 16MG/0.32ML (50MG/ML); 24MG/0.48ML (50MG/ML); 32MG/0.64ML (50MG/ML); 64MG/0.18ML (356MG/ML); 96MG/0.27ML (356MG/ML)

Approved in May 23, 2023, used as Reference Listed Drug

There are 7 future patent(s) for this application. The earliest expires on 2026-07-31, and the latest expires on 2032-07-26.

Patent No	Patent Use Code	Patent Use Definition	Patent Expiration Date	Patent Title
8545832	U-3619	A METHOD OF DELIVERY OF A BIOACTIVE AGENT BY SUBCUTANEOUS INJECTION. A METHOD OF TREATMENT OF A HUMAN FOR ADDICTION	2025-06-06	Lipid depot formulations

CIPROFLOXACIN; DEXAMETHASONE - SUSPENSION/DROPS;OTIC - CIPRODEX

From SANDOZ INC; used to treat middle ear infections inside the ear (also called otitis media), and infections of the outer ear canal (also called otitis externa).

0.3%;0.1%

Approved in Jul 18, 2003, 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
8846650	U-1578	TREATMENT OF ACUTE OTITIS MEDIA	2025-06-04	Method of treating middle ear infections

OMADACYCLINE TOSYLATE - POWDER;INTRAVENOUS - NUZYRA

From PARATEK PHARMACEUTICALS INC; a tetracycline antibiotic used to treat community acquired bacterial pneumonia.

EQ 100MG BASE/VIAL

Approved in Oct 2, 2018, used as Reference Listed Drug and Reference Standard

There are 5 future patent(s) for this application. The earliest expires on 2029-03-05, and the latest expires on 2037-10-31.

Patent No	Patent Expiration Date	Patent Title
7553828	2025-06-02	9-aminomethyl substituted minocycline compounds

OMADACYCLINE TOSYLATE - TABLET;ORAL - NUZYRA

From PARATEK PHARMACEUTICALS INC; a tetracycline antibiotic used to treat community acquired bacterial pneumonia.

EQ 150MG BASE

Approved in Oct 2, 2018, used as Reference Listed Drug and Reference Standard

There are 8 future patent(s) for this application. The earliest expires on 2029-03-05, and the latest expires on 2037-10-31.

Patent No	Patent Expiration Date	Patent Title
7553828	2025-06-02	9-aminomethyl substituted minocycline compounds

Exclusivities Expiring This Week

VENETOCLAX - TABLET;ORAL - VENCLEXTA

From ABBVIE INC; a BCL-2 inhibitor used to treat chronic lymphocytic leukemia, small lymphocytic lymphoma, or acute myeloid leukemia.

100MG

Approved in Apr 11, 2016, used as Reference Listed Drug and Reference Standard

10MG； 50MG

Approved in Apr 11, 2016, used as Reference Listed Drug

There are 2 future exclusivity(ies) for this drug product. The earliest expires on 2025-11-21, and the latest expires on 2026-05-15.

Exclusivity Date	Exclusivity Use Definition
2025-06-08	INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL), WITH OR WITHOUT 17P DELETION, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY