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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.
Lupin 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, Inc., 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).
The inspection concluded with 4 observations, the company said in a regulatory filing. These observations pertain to current good manufacturing practices (cGMP) but do not include any critical issues at this stage.
'We will address the observations and submit our response to the US FDA within the stipulated timeline,' the company stated, adding that it remains committed to full compliance with cGMP quality standards across all its facilities.
The company did not disclose details of the specific product involved in the inspection.
Shares of Lupin fell 0.56% to Rs 2,044.75 on the BSE.