Allergan and its subsidiaries, Forest Laboratories, Forest Laboratories Holdings, and Allergan USA, along with Adamas Pharmaceuticals, have settled patent-infringement litigation with Amneal Pharmaceuticals and Amneal Pharmaceuticals of New York for an abbreviated new drug application (ANDA) for a generic version of Allergan's Namzaric (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination medicine for treating Alzheimer's disease.

This settlement provides additional clarity for the patent-protected life of Namzaric. Under the settlement, and subject to review of the settlement terms by the US 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 US Food and Drug Administration on its ANDA. Alternatively, under certain circumstances, Amneal has an option to launch an authorized generic version of the drug 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 and Amerigen Pharmaceuticals, which have filed an ANDA seeking approval to market generic versions of Namzaric, remains pending in the US District Court for the District of Delaware.

Source: Allergan