The US Food and Drug Administration (USFDA) has tentatively approved Alembic Pharmaceuticals’ Abbreviated New Drug Application (ANDA) Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The approved ANDA is therapeutically equivalent to Otsuka Pharmaceutical Co., Limited’s Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg (RLD) (Otsuka). Brexpiprazole Tablets are prescribed as an adjunctive therapy to antidepressants for the treatment of major depression and schizophrenia. It may not be indicated for certain other uses due to the RLD’s pending exclusivity for such uses.
According to IQVIA, the market for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg is worth US$ 1.6 billion in the twelve months ending December 2022. Alembic has received 184 ANDA approvals from the USFDA (160 final approvals and 24 tentative approvals).