The U.S. Food and Drug Administration (FDA) approved a generic version of lenacapavir on Monday, the only injectable medication for semiannual administration to prevent HIV, in a move that could transform the global fight against the epidemic.
According to AP News, the generic was developed by the Indian laboratory Dr. Reddy's Laboratories under a voluntary royalty-free licensing agreement with Gilead Sciences, negotiated with the involvement of Unitaid, the Clinton Health Access Initiative, and the African research institute Wits RHI.
The medication will cost 40 dollars per person per year in the approximately 120 low- and middle-income countries where it will be available, equivalent to the current cost of daily preventive pills, but with a significant advantage: only two annual injections are required.
"With lenacapavir, we are much more optimistic," said Carmen Pérez Casas, HIV lead at Unitaid, noting that with daily pills, "if you don't take them, you can't protect yourself against HIV."
The approval is considered "tentative," which is the standard designation by the FDA for generics while the original product remains under patent, preventing its marketing in the United States.
The branded lenacapavir, marketed as Yeztugo by Gilead Sciences, has a list price in the U.S. of $28,218 per year, a figure that has generated international pressure to expand access to countries with fewer resources.
The efficacy of the medication is extraordinary. In the PURPOSE 1 study conducted with young women in South Africa and Uganda, no HIV infections were recorded in the group that received lenacapavir, compared to 16 infections in the group that took Truvada daily. In the PURPOSE 2 study, which included men and gender-diverse individuals, only two infections occurred among more than 2,000 participants, representing a 96% reduction compared to the expected incidence without prophylaxis.
Carolyn Amole, director of the HIV program at the Clinton Health Access Initiative, emphasized the potential impact of the advancement: "We could help scale this to the 20 million people worldwide who need PrEP. And if we scale to those levels, we can truly begin to end the HIV epidemic."
Generic licenses cover 24 countries in Latin America and the Caribbean out of a total of 120 benefiting nations, although large countries such as Argentina, Brazil, Mexico, and Peru were excluded from this agreement. For them, the Pan American Health Organization (PAHO) and Gilead announced in September 2026 an alternative acquisition path through the Regional Revolving Funds.
Cuba is also not included among the countries covered by generic licenses, despite the island facing a chronic shortage of antiretroviral medications and condoms that hinder HIV prevention. Oral PrEP was introduced in the country through a pilot program in Matanzas in 2019 and expanded to other provinces since 2022, but the shortage of condoms complicates prevention of the virus.
Before each injection of lenacapavir, an HIV test is required, as administering it to a person with an undiagnosed infection can lead to drug resistance. The most common side effects include reactions at the injection site, headache, and nausea.
According to the World Health Organization, 41 million people were living with HIV in 2025, a year that saw 1.2 million new infections and 570,000 deaths due to virus-related causes.
The first supplies of the generic could arrive in some countries within weeks, although a broader rollout is expected by 2027, subject to each nation's regulatory approval processes. "The work is not done. Now we need the funding to purchase it for everyone who needs it," Amole warned. "But this is a significant milestone."
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