Lupin Gets USFDA Nod for Generic HIV Drug

New Delhi, Feb 3 (PTI) Drug maker Lupin on Monday said it has received approval from the US health regulator to market a generic medication for Human Immunodeficiency Virus.

The company has received tentative approval from the US Food and Drug Administration (USFDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets, the company said in a statement.

The company's product has been found to be therapeutically equivalent to the reference listed drug Symtuza tablets, 800 mg/150 mg/200 mg/10 mg of Janssen Products, LP, it added.


Lupin is the exclusive first-to-file for this product, it stated.

As per the IQVIA MAT December 2024 data, Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets had estimated annual sales of USD 1,374 million in the US.

Shares of Lupin were trading 1.29 per cent down at Rs 2,028.70 apiece on BSE.