Lupin receives tentative FDA approval for generic HIV drug

Lupin Limited announced on September 24, 2025, that it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. This generic drug, bioequivalent to Gilead Sciences' Biktarvy®, is indicated for treating human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg.

The product will be manufactured at Lupin's Nagpur facility in India. The reference listed drug, Biktarvy®, recorded estimated annual sales of $16,237 million in the U.S. as of IQVIA MAT July 2025.

Lupin, headquartered in Mumbai, India, distributes products across over 100 markets and specializes in various pharmaceutical products. The company maintains a strong market presence in key therapy areas across India and the U.S.