"Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for emtricitabine and tenofovir alafenamide tablets, 200 mg/25 mg, 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 (Descovy) had estimated annual sales of USD 3,556 million in the US (IQVIA MAT October2024).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.