Lupin has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets, 800 mg/150 mg/200 mg/10 mg. The product has been found to be bioequivalent and therapeutically equivalent to Janssen Products, LP’s reference listed drug (RLD), Symtuza Tablets, 800 mg/150 mg/200 mg/10 mg.
Lupin is the exclusive first-to-file for this product. It will be manufactured at Lupin’s Nagpur facility in India.
The RLD, Symtuza, had estimated annual sales of USD 1,374 million in the U.S. as of IQVIA MAT December 2024.