Alembic Pharma Secures USFDA Nod for Generic Brexpiprazole Tablets

Alembic Pharmaceuticals Ltd announced that it has secured final approval from the US health regulator for its generic variant of Brexpiprazole tablets, which are used in treating major depressive disorder. The company announced that the US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.

The sanctioned ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti tablets in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg doses, from Otsuka Pharmaceutical Company, Ltd, it noted.

Brexpiprazole is an atypical antipsychotic that serves as an add-on treatment to antidepressants for adults with major depressive disorder (MDD), and it is also employed in the management of schizophrenia in adults and in pediatric patients aged 13 and above.

According to IQVIA data, Alembic reported that Brexpiprazole tablets in dosages of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg are projected to have a market size of USD 2 billion for the 12 months concluding in September 2024.

Alembic Pharmaceuticals Limited is a significant Indian pharmaceutical company involved in manufacturing and marketing. India Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs) worldwide.