The U.S. Food and Drug Administration on Monday gave tentative approval to the first generic version of lenacapavir, a twice-yearly shot that nearly eliminated new HIV infections in large trials. Dr. Reddy’s Laboratories will sell it for about $40 a year in 120 low- and middle-income countries. In the United States, Gilead Sciences charges $28,218 a year for the brand-name version, sold as Yeztugo.
The generic cannot be sold here. Gilead’s patent is still active.
That matters to Black readers because HIV in this country is not evenly spread. Black people are 12% of the U.S. population and were 39% of new HIV diagnoses in 2024, the CDC reports, with a diagnosis rate of 42.2 per 100,000, the highest of any racial or ethnic group. A shot that protects for six months is built for people who find a daily pill hard to keep up. The group with the most to gain is the one the American price keeps furthest from it.
For the countries named in the deal, the approval is a real win. The World Health Organization counts 41 million people living with HIV worldwide and 570,000 HIV-related deaths a year. Dr. Reddy’s developed its version under an arrangement coordinated by Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute in South Africa. The company plans to begin shipping next month, though countries that require their own approvals could see delays. Unitaid’s Carmen Pérez Casas said injections should work better than daily pills because people are more likely to keep taking them.
Gilead will say it granted royalty-free licenses to six generic makers so the drug could reach the places with the highest HIV burden. That is true, and it is why a person in Nairobi or Lagos may get protection at a fraction of 1% of the American price. It also means Gilead drew a line around the one market where it charges the most.
A $28,218 list price shapes what clinics stock, what insurers agree to cover and what a patient without strong coverage is told. For Black Americans, who carry the largest share of new infections, the price is the barrier. The first generic shipments are due in December. The U.S. patent will outlast them.
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