FDA approves generic HIV shot priced at $40 per year

The U.S. Food and Drug Administration approved a generic version of lenacapavir on Monday. The move sets a projected annual cost of $40 for the drug in 120 low- and middle-income countries. This price matches the current cost of daily preventive pills. The new shot requires only two injections per year.

Lenacapavir is the only HIV prevention drug available as a semi-annual injection. It was developed to offer a convenient alternative to daily oral medication. Two major studies showed the shots nearly eliminated new infections among high-risk participants. The approval allows the drug to enter markets where the brand-name version is too expensive or scarce.

Gilead Sciences holds the patent for the brand-name drug, known as Yeztugo in the United States. The U.S. price is $28,218 per year before insurance. Because of this patent protection, the new generic cannot be sold domestically in the U.S. It is available as Yeytuo in Canada and the European Union. Health Canada approved the brand version earlier this year, but Gilead is still negotiating its inclusion in public funding systems.

Until now, Gilead was the sole supplier of lenacapavir. Demand in developing nations has exceeded supply. Last year, Gilead signed royalty-free licensing deals with six generic manufacturers. These agreements cover specific regions in sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson stated the company enabled the fastest path to expanding access for affected communities.

India-based Dr. Reddy's Laboratories developed the first approved generic. The project was brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. These organizations aimed to speed up development and lower costs. Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the new pricing could help scale prevention to 20 million people.

Amole noted that reaching those levels could begin to end the HIV epidemic. Carmen Pérez Casas, HIV lead for Unitaid, said the new option offers much more hope than daily pills. She explained that missed daily doses leave people unprotected. The twice-yearly schedule reduces that risk. The World Health Organization reports 41 million people lived with HIV last year. Another 570,000 died from HIV-related causes.

South Africa began rolling out the brand-name drug earlier this year. The country has the largest population living with HIV, at roughly eight million people. The Global Fund to Fight AIDS, Tuberculosis and Malaria signed a deal with Gilead in 2025 to provide the drug. Officials stated in August that only a generic version would allow for large-scale distribution.

The FDA granted the approval under a practice that ensures quality for HIV drugs provided by the U.S. government to other nations. This designation is considered tentative while the originator patent remains active. Generic versions from other manufacturers have not yet received FDA approval. Common side effects include injection site reactions, headaches, and nausea. Patients must test for HIV before starting treatment and with each injection.

Those involved in the effort expect the generic to become available in some locations within weeks. Other countries may take longer if they require their own regulatory approval. Amole said the work is not done and that funding is needed to buy the drug for everyone. She described the approval as a great milestone. Casas added that the world now has the tools to curb HIV, provided scientific advances are met with political will and funding.