New Delhi, Feb 3 (PTI) – Pharmaceutical giant Lupin has received tentative approval from the U.S. Food and Drug Administration (USFDA) to market a generic version of a combination drug used in the treatment of Human Immunodeficiency Virus (HIV).
In a statement on Monday, the company announced that the approval covers Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets. Lupin's product has been deemed therapeutically equivalent to Symtuza tablets (800 mg/150 mg/200 mg/10 mg) developed by Janssen Products, LP.
Notably, Lupin holds the exclusive first-to-file status for this medication, a significant milestone that positions the company advantageously in the U.S. market.
According to IQVIA MAT data from December 2024, the market for these HIV treatment tablets in the United Statesis valued at approximately $1.37 billion annually.
Despite the positive regulatory development, Lupin’s stock was trading 1.29% lower at ₹2,028.70 per share on the Bombay Stock Exchange (BSE).
In a statement on Monday, the company announced that the approval covers Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide tablets. Lupin's product has been deemed therapeutically equivalent to Symtuza tablets (800 mg/150 mg/200 mg/10 mg) developed by Janssen Products, LP.
Notably, Lupin holds the exclusive first-to-file status for this medication, a significant milestone that positions the company advantageously in the U.S. market.
According to IQVIA MAT data from December 2024, the market for these HIV treatment tablets in the United Statesis valued at approximately $1.37 billion annually.
Despite the positive regulatory development, Lupin’s stock was trading 1.29% lower at ₹2,028.70 per share on the Bombay Stock Exchange (BSE).