U.S. FDA Approves First Generic Injectable Lenacapavir for HIV Prevention, Boosting Global Access

The U.S. Food and Drug Administration (FDA) has granted tentative approval for the first generic long-acting injectable lenacapavir for HIV prevention, developed by Dr. Reddy's Laboratories. This approval comes just 16 months after the originator product and is expected to significantly improve access to an affordable, twice-yearly HIV prevention option in 120 low- and middle-income countries. Initial supplies of the generic are anticipated to reach these countries before the end of 2026, with broader availability in 2027. This milestone follows a landmark pricing agreement aimed at accelerating the development and market entry of generic lenacapavir.