Lupin Limited, a global pharmaceutical company based in Mumbai, has announced that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg. Gilead Sciences, Inc. has approved Lupin to market a generic version of Descovy Tablets, 200 mg/25 mg. 

Lupin qualified for 180 days of shared generic exclusivity as one of the initial ANDA applicants. Lupin's advanced facility in Nagpur, India will produce the product.

Adults and adolescents treat HIV-1 infection with Emtricitabine and Tenofovir Alafenamide Tablets. Pre-exposure prophylaxis (PrEP), which lowers the risk of HIV-1 infection, also receives approval for these tablets. 

As per IQVIA MAT data from October 2024, the branded drug Descovy achieved annual sales of around USD 3.56 billion in the United States. 

A spokesperson for Lupin commented on the approval, stating, "This milestone underscores our continuous dedication to providing high-quality, affordable medications to patients around the world." The approval of our generic version of Descovy strengthens Lupin’s role as a reliable partner in enhancing healthcare. 

This approval enhances Lupin’s range of HIV treatments and highlights the company’s capacity for innovation and effective execution in a tightly regulated market.