U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.

The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg. Lupin said it would be manufacturing the product at its Nagpur facility.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (RLD Biktarvy) had estimated annual sales of $16,237 million in the U.S., the company said citing IQVIA MAT July 2025 numbers.