FDA approves first generic twice-yearly HIV-prevention shot

The FDA on Nov. 2, 2026, approved the first generic version of lenacapavir, a twice-yearly HIV-prevention shot made by India's Dr. Reddy's Laboratories under a Gilead voluntary license signed in October 2024. Sales are limited to 120 high-incidence, resource-limited countries at about $40 per person per year. Supplies could reach some countries, including Zambia, by year's end. Gilead's Yeztugo lists at $28,218 a year in the U.S. and remains patent-protected; the generic cannot be sold there. The approval is tentative. Only Dr. Reddy's among six royalty-free licensees has FDA approval so far. Carmen Pérez Casas of Unitaid said people who do not take daily pills cannot get protected against HIV and that with lenacapavir they are much more hopeful. Carolyn Amole of the Clinton Health Access Initiative said it could help scale PrEP to 20 million people who need it and begin to end the HIV epidemic. A Gilead spokesperson said the company shares urgency on access and enabled the fastest sustainable path. Saiqa Mullick of Wits RHI said PrEP requires advance HIV testing, often a rapid test in low- and middle-income countries. Side effects include injection site reactions, headache and nausea.