Lupin shares surge over 2% on tentative USFDA approval for HIV-treatment tablets

At around 11:17 am, the stock was trading 1.08% higher at ₹2,012.40 per equity share.

This comes after the pharmaceutical company received tentative approval from the United States Food and Drug Administration (USFDA) for treatment drugs for human immunodeficiency virus (HIV) infection, it said in a regulatory filing on Wednesday.

The USFDA has approved the pharma major’s abbreviated new drug application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, available in strengths of 50 mg/200 mg/25 mg.

The medicines, which will be manufactured at Lupin’s Nagpur facility, are the bioequivalents of Gilead Sciences’ Biktarvy tablets, 50 mg/200 mg/25 mg, the drugmaker added.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy) had estimated annual sales of $16,237 million in the U.S, according to IQVIA MAT.

Other approvals

On September 17, the company had received approval from the US health regulator for Lenalidomide Capsules, available in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg. It is used in the treatment of Multiple Myeloma (MM), in combination with dexamethasone. It is also used in the case of MM, as maintenance following autologous hematopoietic stem cell transplantation.

In a separate filing earlier this month, Lupin said that it received a nod for Risperidone for extended-release injectable suspension, in 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials.

Lupin stock performance

Shares of Lupin declined 1.39% over the week but gained 4.05% over a period of three months. It slipped 1.53% over six months.

On a year-to-date basis, the scrip has fallen 14.46%.

While the stock reached a 52-week low of ₹1,795.20 on April 7, 2025, it touched a year’s low of ₹2,402.90 on January 2, 2025.

Lupin Ltd has a total market capitalisation of ₹91,953.82 crore, as of September 25, 2025, according to data on the NSE.