Lupin's Generic HIV Drug Gets Tentative FDA Nod

Lupin Ltd has received tentative approval from the US FDA for its generic version of HIV treatment Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets. This generic drug, bioequivalent to Biktarvy, will be produced at Lupin's Nagpur facility and targets a significant market with annual sales of USD 16,237 million.

In a significant development, Lupin Ltd announced on Wednesday that it has secured tentative approval from the US Food and Drug Administration (FDA) for its generic version of the HIV treatment involving Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets.

The approval pertains to an abbreviated new drug application for tablets of 50 mg/200 mg/25 mg, set to be produced at Lupin's Nagpur facility. This generic formulation is bioequivalent to Gilead Sciences' Biktarvy tablets, already a mainstay in HIV treatment for adults and children weighing at least 25 kg.

Lupin cited IQVIA MAT July 2025 data, highlighting the financial potential of this market, with Biktarvy tablets showing estimated annual sales of USD 16,237 million in the US alone.