Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of
Erleada® Tablets, 60 mg of Janssen Biotech, Inc. This product will be manufactured at Lupin's Pithampur facility in India.
Apalutamide Tablets, 60 mg, (RLD Erleada®) had estimated annual sales of USD 1,185.5 million in the U.S. (IQVIA MAT July 2023).