Lupin Limited secures tentative FDA nod for generic Apalutamide Tablets

In a significant stride for global pharmaceuticals, Lupin Limited has garnered tentative approval from the United States Food and Drug Administration (U.S. FDA) to introduce its generic version of Apalutamide Tablets, 60 mg, echoing the renowned Erleada Tablets by Janssen Biotech, Inc.

With an aim to tap into the vast US market, Lupin’s Abbreviated New Drug Application (ANDA) for this venture signals an encouraging development for patients and the pharmaceutical industry alike. The tablets are devised to match the quality and efficacy of Erleada® Tablets, 60 mg, a market leader.

Highlighting its robust manufacturing infrastructure, the production of these generic tablets will be helmed by Lupin’s state-of-the-art Pithampur facility located in India.

To provide a perspective on the market magnitude, Apalutamide Tablets, 60 mg, (RLD Erleada) recorded an impressive estimated annual sales figure of USD 1,185.5 million in the U.S., as per IQVIA MAT data up to July 2023.

Lupin’s strategic move to produce and market this generic equivalent reinforces its commitment to deliver high-quality, affordable medicines to patients across the US and further cements its reputation as a leading pharma brand globally.