Lupin Receives Tentative Approval from U.S. FDA for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets
Mumbai, Naples, September 24, 2025: Global pharma major Lupin Limited (Lupin) today announced that it 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).
About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries please contact –
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
*Safe Harbor Statement
Biktarvy® is a registered trademark of Gilead Sciences Ireland Unlimited Company
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