Lupin receives FDA nod for generic Descovy

Lupin has received approval from the Food and Drug Administration for emtricitabine and tenofovir alafenamide tablets, 200 mg/25 mg, which is a generic of Gilead Sciences’ Descovy. 

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.

Generic Descovy is indicated for the treatment of HIV-1 Infection and for pre-exposure prophylaxis to reduce the risk of HIV-1 infection in adults and adolescents.

FDA gives Lupin tentative OK for generic Triumeq PD

Emtricitabine and tenofovir alafenamide tablets (RLD Descovy) had a market value of roughly $3.6 billion, per IQVIA October data.

[Read more: FDA gives Lupin tentative nod for generic Janumet]