Lupin bags tentative USFDA nod for generic equivalent of Janssen Biotech Erleada Tablets

Mumbai: Global pharma major Lupin Limited has announced that the Company 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).

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Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers.

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