A $40-A-Year Generic HIV Prevention Shot Wins Tentative FDA Approval

The U.S. Food and Drug Administration has granted Dr. Reddy's Laboratories tentative approval for a generic version of injectable lenacapavir, the twice-yearly shot used to prevent HIV infection. Dr. Reddy's and its partners Unitaid, Wits RHI and the Clinton Health Access Initiative announced the decision Nov. 2, 2026.

Tentative approval is not permission to sell the drug in the United States. In a joint release, the four organizations say that it is the FDA's standard designation for a generic while the originator is still under patent, and that it lets the U.S. government buy the product. They also say that it gives national regulators elsewhere a foundation to build on, and that the injection offers people at risk of HIV a prevention option that does not require a daily pill.

Under their existing partnership agreement, Dr. Reddy's injection will be available at $40 per person per year in the 120 low- and middle-income countries that Gilead's voluntary license covers. The organizations say more than 125,000 people in African countries where the shot was first introduced have already started on Gilead's version, and expect first supplies of the generic to reach countries before the end of 2026, with wider availability the following year.

Saiqa Mullick, director of implementation science at Wits RHI, said an affordable drug on its own is not enough: countries will also need health systems ready to deliver new prevention options, providers confident in offering them, and communities engaged in introducing them.

The FDA approved Gilead's originator product for HIV prevention in June 2025, and the generic followed 16 months later. Gilead granted voluntary licenses for lenacapavir to six generic manufacturers, Dr. Reddy's among them. The partners say Dr. Reddy's combined the drug's two uses, prevention and treatment, in a single application, which let it ask the FDA for a priority review.