Lupin Advances in HIV Treatment Market with FDA Nod for Darunavir-Cobicistat Combo

Lupin Limited has announced receiving tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Darunavir and Cobicistat tablets. This HIV treatment combination is a generic equivalent of Janssen's Prezcobix®. The tentative approval signifies that the product meets FDA standards for quality, safety, and efficacy, but cannot be marketed in the U.S. due to existing patent protections. This development strengthens Lupin's HIV medication portfolio, following recent approvals for other antiretroviral drugs. The company's Nagpur facility will manufacture the product, positioning Lupin to potentially capture market share once patent exclusivity expires.

Source: Lupin Limited Corporate Announcement, February 3, 2025