Lupin shares gain 2% after USFDA approval for HIV drug – News Air Insight

Shares of Lupin rose 2.2% to hit the day’s high of Rs 2,034.95 on BSE on Thursday, September 25, after the company received tentative approval from the U.S. FDA for its HIV treatment drug, in a segment with estimated annual U.S. sales of $16,237 million (as of July 2025, IQVIA).

“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,” Lupin said in a regulatory filing to the stock exchanges.

The approval is for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (50 mg/200 mg/25 mg) — a generic version of Gilead Sciences’ Biktarvy. The tablets are used in the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg. The product will be manufactured at Lupin’s Nagpur facility in India.

The development positions Lupin to potentially tap into one of the largest segments in the U.S. HIV drug market. Though the approval is currently tentative, it allows Lupin to move closer to eventual commercial launch in a highly lucrative space.

Lupin is a global pharmaceutical company headquartered in Mumbai, with a presence in over 100 markets. The company specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs).

Lupin holds a strong position in both India and the U.S. across multiple therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company operates 15 state-of-the-art manufacturing sites and 7 research centers around the world, supported by a workforce of over 23,000 professionals.On Wednesday, the shares of Lupin closed 0.72% lower at Rs 1,991.20 on the BSE.Also read: GST 2.0, festive demand boost auto outlook; analysts reveal their top 3 auto stock picks

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