Patent and Exclusivity Expirations Report

Report generated for the week of 2025-03-31 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:

• WAINUA by AstraZeneca, containing active ingredient Eplontersen Sodium

• HORIZANT by Azurity Pharmaceuticals, containing active ingredient Gabapentin Enacarbil

• IGALMI by BioXcel Therapeutics, containing active ingredient Dexmedetomidine Hydrochloride

• RUBRACA by PharmaAND, containing active ingredient Rucaparib Camsylate

Patents Expiring This Week

EPLONTERSEN SODIUM - SOLUTION;SUBCUTANEOUS - WAINUA (AUTOINJECTOR)

From ASTRAZENECA AB; a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.

EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)

Approved in Dec 21, 2023, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2034-05-01, and the latest expires on 2034-08-25.

Patent No	Patent Expiration Date	Patent Title
8101743	2025-04-01	Modulation of transthyretin expression

GABAPENTIN ENACARBIL - TABLET, EXTENDED RELEASE;ORAL - HORIZANT

From AZURITY PHARMACEUTICALS INC; to treat adults with restless legs syndrome and pain from damaged nerves.

300MG

Approved in Dec 13, 2011, used as Reference Listed Drug

600MG

Approved in Apr 6, 2011, used as Reference Listed Drug and Reference Standard

There are 3 future patent(s) for this application. The earliest expires on 2026-04-11, and the latest expires on 2029-06-10.

Patent No	Patent Expiration Date	Patent Title
6818787	2025-04-06	Prodrugs of GABA analogs, compositions and uses thereof

Exclusivities Expiring This Week

DEXMEDETOMIDINE HYDROCHLORIDE - FILM;BUCCAL, SUBLINGUAL - IGALMI

From BIOXCEL THERAPEUTICS INC; for the treatment of agitation associated wiht schizophrenia or bipolar disorder.

EQ 0.12MG BASE; EQ 0.18MG BASE

Approved in Apr 5, 2022, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-04-05	NEW PRODUCT

RUCAPARIB CAMSYLATE - TABLET;ORAL - RUBRACA

From PHARMAAND GMBH; a PARP inhibitor used to treat recurrent ovarian and prostate cancers in previously treated adults.

EQ 200MG BASE

Approved in Dec 19, 2016, used as Reference Listed Drug

EQ 250MG BASE

Approved in May 1, 2017, used as Reference Listed Drug

EQ 300MG BASE

Approved in Dec 19, 2016, used as Reference Listed Drug and Reference Standard

There are no future exclusivities for this application.

Exclusivity Date	Exclusivity Use Definition
2025-04-06	FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY