Lupin gets USFDA tentative nod for HIV drug generic, to be made in Nagpur

Lupin said the product will be manufactured at its Nagpur facility.

Pharma major Lupin Ltd on Wednesday announced that it has received tentative approval from the US Food and Drug Administration (USFDA) to market its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, used in the treatment of HIV infection.

The approval is for tablets of strength 50 mg/200 mg/25 mg, which are bioequivalent to Gilead Sciences’ Biktarvy, a leading HIV treatment.

Lupin said the product will be manufactured at its Nagpur facility.

The drug is indicated for the treatment of HIV infection in adults and pediatric patients weighing at least 25 kg.

According to IQVIA MAT July 2025 data, Biktarvy tablets had estimated annual sales of USD 16.2 billion in the US, underscoring the potential market opportunity for Lupin’s generic.