The drug is the generic version of Biktarvy Tablets (50 mg/200 mg/25 mg), marketed by Gilead Sciences, Inc., and is indicated for the treatment of HIV infection in adults and pediatric patients weighing at least 25 kg. Lupin’s version of the drug will be manufactured at its facility in Nagpur, India.

According to IQVIA data for the 12 months ending July 2025, Biktarvy had estimated annual sales of $16,237 million in the U.S. market.

This tentative approval marks another milestone in Lupin’s strategy to expand its complex generics portfolio in the U.S. market. The approval paves the way for Lupin to launch the drug upon patent expiry or final regulatory clearance.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The company's consolidated net profit jumped 52.13% to Rs 1,219.03 crore on an 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.