Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg

Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.  This product would be manufactured at Lupin’s Nagpur facility in India.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy) had estimated annual sales of USD 16,237 million in the U.S. (IQVIA MAT July 2025).