Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) 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, Inc., and indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and paediatric patients weighing at least 25 kg.

As per IQVIA MAT July 2025, Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets had estimated annual sales of USD 16,237 million in the US.