Alembic Pharmaceuticals Limited announces USFDA Final Approval for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg

15th January, 2025 Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, of Otsuka Pharmaceutical Company, Ltd. (Otsuka). Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults, and also used in treatment of schizophrenia in adults and pediatric patients ages 13 years and older. Refer label for a detailed indication.

Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of US$ 2.0 billion for twelve months ending September 2024 according to IQVIA.

Alembic has a cumulative total of 220 ANDA approvals (194 final approvals and 26 tentative approvals) from USFDA.