Lupin receives tentative approval for Brexpiprazole tablets

This product will be manufactured at Lupin’s Pithampur facility In India

Lupin announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, to market a generic equivalent of Rexulti tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical Co., Ltd. This product will be manufactured at Lupin’s Pithampur facility in India.

Brexpiprazole tablets (RLD: Rexu1ti tablets) had estimated annual sales of US $ 1258 million In the U.S. (IQVIA MAT July 2021).