Lupin Limited has informed the Exchange regarding a press release dated September 24, 2025, titled "Lupin Receives Tentative Approval from U.S. FDA for Bictegravir, Emtricitabine, andTenofovir Alafenamide Tablets".
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Lupin has received tentative approval from the U.S. FDA for its generic version of Biktarvy® (Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg), used to treat HIV in adults and pediatric patients weighing at least 25 kg. The product will be made at Lupin's Nagpur facility in India. The branded reference drug, Biktarvy® from Gilead Sciences, had estimated annual U.S. sales of around USD 16.2 billion (IQVIA MAT July 2025), making this a large potential market opportunity. The approval is 'tentative,' meaning Lupin cannot launch the product commercially in the U.S. until existing patent or exclusivity issues on the brand are resolved.
Positive signal for Lupin's U.S. generics pipeline, as it positions the company to compete in a multi-billion dollar HIV therapy market once final approval is granted. However, since this is only a tentative approval, there is no immediate revenue impact, and the actual launch timeline depends on resolution of patent hurdles.