NAMZARIC patent litigation settlement announced

Allergan plc sealed a settlement agreement this week with Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York LLC.

Amneal had filed an abbreviated new drug application (ANDA) to market generic versions of Allergan's Alzheimer's medication NAMZARIC (memantine hydrochloride and donepezil hydrochloride).

Adamas Pharmaceuticals Inc. and Allergan's subsidiaries Forest Laboratories LLC, Forest Laboratories Holdings Ltd. and Allergan USA filed suit to protect the NAMZARIC patent. The settlement will allow Amneal to market generic versions of NAMZARIC on Jan. 1, 2025. The U.S. Food and Drug Administration (FDA) must provide the final approval of the ANDA for the generic drug.

NAMZARIC is used in conjunction with 10 mg of ARICEPT (donepezil hydrochloride) to treat Alzheimer's disease. Allergan owns the U.S. rights and Adamas holds the rights outside of the U.S.

"Allergan is proud of its commitment to providing therapies and advancing the development of new treatments that can help the millions of patients and their caregivers living with Alzheimer's disease," Allergan Chief Commercial Officer Bill Meury said. "Our recently announced expanded label for NAMZARIC allows patients with moderate-to-severe Alzheimer's disease, who are currently stabilized on Aricept, to start combination therapy directly with NAMZARIC. Approximately 75 percent of patients diagnosed with Alzheimer's disease are in the moderate-to-severe stage of the disease and yet only about one-third of these patients are currently treated with combination therapy."

In addition to the Amneal lawsuit, Allergan, Forest and Adamas have similar litigation pending against Amerigen Pharmaceuticals Inc. and Amerigen Pharmaceuticals Ltd. Amerigen is also seeking approval to market generic NAMZARIC.