Lupin Secures FDA Nod for HIV Drug, First-to-File Status

Global pharmaceutical leader Lupin Limited has secured tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets (800 mg/150 mg/200 mg/10 mg), a generic equivalent of Symtuza® by Janssen Products. The approval affirms Lupin’s formulation as bioequivalent and therapeutically equivalent to the reference drug, enabling it to provide a cost-effective alternative in the U.S. HIV treatment market. Notably, Lupin has achieved first-to-file status for this product, reinforcing its leadership in the generics industry.

Manufactured at Lupin’s Nagpur facility in India, this combination therapy is a critical treatment option for HIV-1 infection. The branded version, Symtuza®, recorded U.S. sales of approximately $1.37 billion in 2024, highlighting the significant market opportunity. With this approval, Lupin is poised to strengthen its presence in the HIV treatment landscape, expanding access to essential therapies for patients while reinforcing its commitment to global healthcare.