Amneal Announces FDA Approval For Dementia And Oncology Therapies, Tentative Approval For IBS-D Drug; 180-Day Exclusivity For Memantine/Donepezil

Approval of three important therapies for dementia, oncology and gastrointestinal disease

Granted 180-day exclusivity for memantine/donepezil extended-release capsules

Tentative approval of rifaximin, a product for treating IBS-D

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) ("Amneal" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie's NAMZARIC®, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis' AFINITOR DISPERZ®. In addition, the FDA has granted tentative approval to Amneal's rifaximin 550 mg oral tablets, which references Bausch Health's XIFAXAN®. The FDA approval was tentative as this product is involved in litigation.

Memantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. The product has launched with 180-day exclusivity.

Everolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older. This launch increases the supply of an oncology product that has limited suppliers.

Rifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.