Allergan, Adamas Announce Settlement With Amneal On NAMZARIC Patent Litigation

(RTTNews) - Allergan plc (AGN) announced that its subsidiaries Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd. and Allergan USA, along with Adamas Pharmaceuticals Inc. (ADMS), have entered into a settlement agreement with Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC.

The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal's abbreviated new drug application (ANDA) seeking approval to market generic versions of Allergan's NAMZARIC (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI). It is Allergan's understanding that Amneal is the first applicant to file an ANDA containing a paragraph IV certification regarding NAMZARIC.

The settlement provides additional clarity for the patent-protected life of NAMZARIC. Under the terms of the settlement agreement, and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest and Adamas will grant Amneal a license to market generic versions of NAMZARIC beginning on January 1, 2025, following receipt by Amneal of final approval from the U.S. Food and Drug Administration on its ANDA for generic NAMZARIC. Alternatively, under certain circumstances, Amneal has an option to launch an authorized generic version of NAMZARIC beginning on January 1, 2026. Other terms of the settlement were not disclosed.

Similar patent infringement litigation brought by Allergan, Forest and Adamas against Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals Ltd., which have filed an ANDA seeking approval to market generic versions of NAMZARIC remains pending in the U.S. District Court for the District of Delaware.