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).