Lupin secures FDA approval for generic Emtricitabine and Tenofovir Alafenamide tablets

Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, marking it as a generic equivalent of Gilead Sciences, Inc.’s Descovy Tablets, 200 mg/25 mg. Lupin is among the first ANDA applicants, qualifying for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s facility in Nagpur, India.

Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment of HIV-1 infection and pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in adults and adolescents.

Emtricitabine and Tenofovir Alafenamide Tablets (RLD Descovy) had estimated annual sales of USD 3,556 million in the U.S. (IQVIA MAT October2024)