Global pharma major Lupin Limited on Wednesday announced that it 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.
According to the company’s statement, the approval has been granted to market a generic equivalent of Descovy Tablets, 200 mg/25 mg of Gilead Sciences, Inc. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment of HIV-1 Infection and for 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).
