Global pharmaceutical company Lupin Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.
The product, which will be manufactured at Lupin’s Nagpur facility, is bioequivalent to Gilead Sciences’ Biktarvy® tablets and is indicated for the treatment of HIV infection in adults and pediatric patients weighing at least 25 kg.
According to IQVIA MAT July 2025 data, the reference drug Biktarvy® had estimated annual sales of USD 16.2 billion in the US, highlighting the market potential of Lupin’s generic version.
Founded in Mumbai, Lupin is one of India’s leading pharmaceutical players with a presence in over 100 markets, specializing in branded and generic formulations, complex generics, and APIs. The company maintains strong positions across therapy areas including respiratory, cardiovascular, anti-diabetic, gastrointestinal, and women’s health.
