FDA Tentatively Approves First Generic Lenacapavir, a Twice-Yearly HIV Prevention Shot Priced at 40 Dollars a Year

The US Food and Drug Administration has tentatively approved a generic version of lenacapavir, a twice-yearly injectable drug for HIV prevention made by Dr Reddy's Laboratories of India. Dr Reddy's is the first of six generic manufacturers licensed by Gilead Sciences to receive tentative FDA approval for the drug.

Tentative approval means the product meets FDA standards for safety, efficacy and quality, but it cannot yet be sold in the United States because of patent or exclusivity issues. The decision still matters outside the United States. It makes the product eligible for purchase under the US PEPFAR pathway, and it gives regulators in other countries a reference point as they review the same drug.

Built for 120 countries

The generic is intended for the 120 low and middle income countries covered by Gilead's voluntary licensing program. The expected price is 40 dollars per person per year. The branded version, sold as Yeztugo in the United States, costs about 28,000 dollars a year, with a list price of 28,218 dollars per year.

Lenacapavir was developed by Gilead Sciences and was approved for HIV prevention in June 2025. In large clinical trials it was nearly 100 percent effective, and AFP reported effectiveness of more than 99.9 percent. The drug is given by injection twice a year, so a person needs two injections a year instead of a daily pill schedule.

Who is backing the rollout

Unitaid, a global health agency hosted by the World Health Organization, is providing technical and financial support to Dr Reddy's. The Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute at the University of the Witwatersrand are also supporting the work.

A pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative and Dr Reddy's paired the early 40 dollar pricing commitment with financial, technical and regulatory support. Jessica Burry, a technical officer at Unitaid, said: "There are some countries who would be able to fast-track regulatory approvals based on a reliance mechanism on the US FDA."

Initial supplies of the twice-yearly injection are expected to reach a few low income countries by the end of 2026. A broader rollout is expected in 2027, and Zambia could be one of the first countries to receive it. Five other licensed generic makers have yet to receive the same tentative approval, so further decisions of this kind are still to come.