The US Food and Drug Administration has tentatively approved a generic version of lenacapavir, the twice-yearly injection that prevents HIV, in a decision global health groups say could transform prevention in the countries hardest hit by the virus.
The generic, made by India’s Dr Reddy’s Laboratories, is the first of six licensed manufacturers to clear FDA review. It cannot yet be sold in the United States, where Gilead Sciences’ branded version, Yeztugo, remains under patent. Instead, the tentative approval clears the way for US government procurement and supply to 120 low- and middle-income countries covered by Gilead’s voluntary licensing agreements.
The price difference is stark. The generic is expected to cost $40 per person per year, roughly the same as daily preventive pills, against a US list price of about $28,000 a year for the branded injection. First supplies are expected to reach a few low-income countries before the end of 2026, with a broader rollout in 2027. Zambia could be among the first recipients, according to Unitaid.
Lenacapavir is a long-acting form of pre-exposure prophylaxis, or PrEP: a single injection every six months that has proved nearly 100% effective in large trials. Health experts have described it as a potential game-changer because it removes the need to take a daily pill, a burden that has limited uptake of existing prevention, particularly among young women and other groups at high risk.
The speed of the approval is itself notable. Gilead’s branded product was approved by the FDA in June 2025, and the generic followed just 16 months later, accelerated by a partnership between Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute in South Africa. A landmark pricing agreement struck in September 2025 fixed the $40 annual price.
The approval is “tentative” in the FDA’s standard sense: the drug has met the agency’s safety, efficacy and quality standards but cannot be marketed in the US while the originator’s patent stands. Further steps remain before the shot reaches patients at scale, including World Health Organization prequalification and national regulatory approvals in each recipient country.
Even so, campaigners see the decision as the moment a prevention tool long priced out of reach for most of the world begins to become a realistic option. For countries where HIV still claims hundreds of thousands of lives a year, a twice-yearly injection at the price of daily pills could close one of the widest gaps in global health.
Sources: Reuters, “Dr Reddy’s gets tentative US FDA nod for generic HIV prevention” (https://www.reuters.com/legal/litigation/dr-reddys-gets-tentative-us-fda-nod-generic-hiv-prevention-2026-11-02/); Clinton Health Access Initiative, “U.S. FDA approves first generic injectable lenacapavir for HIV prevention” (https://www.clintonhealthaccess.org/news/us-fda-approves-first-generic-injectable-lenacapavir-for-hiv-prevention/).
