Lupin has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, used to treat HIV. The tablets, 50 mg/200 mg/25 mg, are bioequivalent to Gilead Sciences’ Biktarvy and will be manufactured at Lupin’s Nagpur facility. Biktarvy had estimated annual sales of USD 16,237 million in the U.S. (IQVIA MAT July 2025).
FDA Approval for HIV Treatment
Lupin Limited has secured tentative approval from the United States Food and Drug Administration (U.S. FDA) for its application regarding Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets. This approval was announced on September 24, 2025.
Product Details and Manufacturing
The approved tablets are available in a 50 mg/200 mg/25 mg dosage. These tablets are bioequivalent to Biktarvy® Tablets from Gilead Sciences, Inc. Lupin plans to manufacture this product at its facility located in Nagpur, India. The drug is indicated for treating human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg.
Market Impact
The reference product, Biktarvy®, which Lupin’s tablets are bioequivalent to, had significant sales. Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy®) recorded estimated annual sales of USD 16,237 million in the U.S., as of IQVIA MAT July 2025.
Source: BSE
