Lupin Gains USFDA Nod for Generic HIV Drug Launch

Lupin has obtained approval from the USFDA to market a generic form of an HIV medication. The approved drug, equivalent to Symtuza tablets, positions Lupin as the exclusive first-to-file. The tablets had estimated US sales of USD 1,374 million in 2024. Lupin shares showed a slight dip following the announcement.

Indian pharmaceutical company Lupin announced on Monday that it has secured approval from the US Food and Drug Administration (USFDA) to introduce a generic HIV medication to the American market.

The approved product includes combinations of Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide, deemed equivalent to Janssen Products' branded Symtuza tablets, comprising 800 mg/150 mg/200 mg/10 mg dosages.

This new entry makes Lupin the exclusive first-to-file applicant for this particular medication. According to data from the IQVIA MAT December 2024, the original branded tablets reportedly accumulated annual sales worth USD 1,374 million in the US market. Meanwhile, Lupin's stock was observed trading at Rs 2,028.70 on BSE, reflecting a slight decline of 1.29 per cent.