The news highlights a significant milestone for Lupin, a prominent player in the generic drug market. They’ve earned tentative approval from the U.S. Food and Drug Administration (FDA) for their abbreviated new drug application (ANDA) concerning a crucial combination tablet. This medication, comprising Bictegravir, Emtricitabine, and Tenofovir Alafenamide (50 mg/200 mg/25 mg), is set to offer a more accessible option for patients.
This newly approved generic is bioequivalent to Gilead Sciences’ highly effective Biktarvy Tablets (50 mg/200 mg/25 mg), which are widely used for treating human immunodeficiency virus (HIV) infection. The approval covers both adults and pediatric patients weighing at least 25 kg, broadening the scope of its potential impact.
Lupin has confirmed that the manufacturing of this vital HIV drug will take place at its advanced production facility in Nagpur, India. This strategic decision underlines the company’s commitment to global healthcare and strengthens its manufacturing footprint. The original brand-name drug, Biktarvy, recorded impressive annual sales of approximately $16,237 million in the U.S. market as of July 2025 (according to IQVIA MAT data), underscoring the substantial demand and the potential market for Lupin’s generic alternative. This approval is a crucial step in expanding access to essential HIV therapies for patients in need.