The U.S. Food and Drug Administration has granted tentative approval to the first generic version of injectable lenacapavir, the twice-yearly HIV prevention shot. The generic is made by India-based Dr. Reddy’s Laboratories, and Unitaid announced the approval on November 2.

The generic will cost $40 per person per year. That price applies in the 120 low- and middle-income countries covered by Gilead’s voluntary license, according to Unitaid. First supplies are expected by the end of 2026, with broader availability in 2027.

Why It Matters

The approval comes 16 months after the FDA approved Gilead’s original lenacapavir for prevention in June 2025. Gilead sells that shot in the U.S. as Yeztugo, and it launched at a list price of $28,218 a year, Drugs.com reported at the time.

Under the FDA’s rules, tentative approval is the standard status for a generic while the original drug is still under patent. Unitaid says the status also allows U.S. government purchasing for programs abroad. Gilead granted royalty-free licenses to six generic makers in October 2024 but those licenses limit sales to the 120 covered countries.

The effort was backed by Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI). More than 125,000 people in 10 African countries have already started Gilead’s version, according to Unitaid.

“Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” said Dr. Neil Buddy Shah, CHAI’s chief executive.

What It Means at Home

The U.S. gap is uptake, not science. The CDC estimated that only 13% of Black people who could benefit from PrEP had been prescribed it, compared with 36% of all eligible people in 2022. The CDC notes that race data were missing for many prescriptions, so the estimate should be read with caution.

For Black men, a shot every six months could remove some of the hurdles of a daily pill. Cost and insurance coverage still decide who actually gets it.

For now, the $40 generic is headed abroad, while American patients rely on insurance coverage for the brand-name shot. The approval shows how fast a breakthrough can become affordable when price is treated as part of the plan.

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