FDA grants tentative approval to first generic lenacapavir for HIV prevention at $40 a year

The U.S. Food and Drug Administration granted tentative approval on 2 November to the first generic version of injectable lenacapavir for HIV prevention. The product, made by India’s Dr. Reddy’s Laboratories, is expected to cost $40 per person per year in 120 low- and middle-income countries covered by Gilead’s voluntary licensing programme.

Tentative approval is the FDA’s standard designation for a generic while the originator remains under patent. It does not allow sale in the United States, but it qualifies the product for purchase with U.S. government funding for use abroad. Gilead’s branded version, Yeztugo, received full FDA approval for pre-exposure prophylaxis in June 2025 and carries a U.S. list price of $28,218 per year.

The generic reached tentative approval 16 months after the originator. Unitaid, the Clinton Health Access Initiative and Wits RHI worked with Dr. Reddy’s to accelerate development and regulatory filing. Dr. Reddy’s combined the prevention and treatment indications in a single application under the 505(b)(2) pathway and received priority review.

In Gilead’s pivotal PURPOSE 1 trial, no infections occurred among 2,134 participants who received lenacapavir. PURPOSE 2 recorded two infections among 2,179 participants. The drug is a capsid inhibitor given as a subcutaneous injection every six months.

More than 125,000 people in Africa have already started on the originator product, according to CHAI CEO Neil Buddy Shah. Initial supplies of the generic are expected to reach countries by the end of 2026, with broader availability in 2027. The $40 annual price matches the current cost of daily oral PrEP pills in many of the same markets.

Gilead granted voluntary licences to six generic manufacturers, including Dr. Reddy’s, in late 2024. The rapid timeline is shorter than the decade often required for generic HIV drugs to reach low-income markets after originator approval. FDA clearance under the long-standing pathway for U.S.-funded antiretrovirals also helps speed national approvals elsewhere.

The product cannot be sold in the United States while Yeztugo’s patents remain in force. Gilead has said the U.S. list price is comparable to other PrEP options. Health organisations involved in the generic effort said scaling access to the twice-yearly injection could accelerate progress toward ending the HIV epidemic in high-burden countries.

This approval marks one of the fastest moves from originator clearance to a quality-assured generic for a major HIV innovation. First shipments are scheduled before the close of 2026.