Generic HIV Shot Approved at $40 a Year, Targeting 120 Nations

The U.S. Food and Drug Administration has cleared a generic version of lenacapavir, the first twice-yearly injection for HIV prevention.

The approval was announced Monday by the manufacturer and partner organizations, marking a regulatory step toward making the drug available in 120 low- and middle-income countries at a lower price point. The generic formulation is projected to cost $40 per person annually in those markets. This price matches the current cost of daily preventive pills, which are widely used but often difficult for patients to maintain consistently.

Carmen Pérez Casas, HIV lead for the grant-making organization Unitaid, noted that daily adherence is a common barrier. She stated that without the daily dose, protection against HIV is lost. With the injection, she said, the agency is much more hopeful. The drug showed high efficacy in two prior studies involving people at high risk, nearly eliminating new infections among participants.

Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said the new generic should help scale pre-exposure prophylaxis, or PrEP, to the 20 million people globally who need it. She added that reaching that scale could begin to end the HIV epidemic. The World Health Organization reported that 41 million people were living with HIV and 570,000 died from related causes last year.

The generic is not yet available in the United States because the brand-name version, Yeztugo, made by Gilead Sciences, remains under patent protection. The U.S. list price for Yeztugo is $28,218 per year, a figure Gilead officials say is comparable to other PrEP options. The FDA granted a tentative approval for the generic under a longstanding practice designed to ensure the quality of HIV drugs provided to other countries by the U.S. government. This designation allows the drug to move forward in international markets while the originator patent is active.

Gilead had been the sole supplier of lenacapavir until last year, when demand in low- and middle-income countries outstripped supply. The company established royalty-free licensing agreements with six generic manufacturers to enable production in specific regions of sub-Saharan Africa, Asia, and Latin America. A Gilead spokesperson said the company enabled the fastest and most sustainable path to expanding access for communities most affected by HIV.

The specific generic approved was developed by India-based Dr. Reddy’s Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI. Common side effects include injection site reactions, headache, and nausea. Patients must test for HIV before starting the drug and with each injection, as drug-resistant strains have been identified in people with undiagnosed infections. Saiqa Mullick, director of implementation science with Wits RHI, said that for many of these countries, the required testing is a rapid test.

Generic lenacapavir should begin reaching some locations within weeks, though timelines may vary for countries requiring separate regulatory approvals. Other generic versions from different manufacturers have not yet received FDA approval. Amole said the next steps involve securing funding to purchase the drug for everyone who needs it and distributing it to millions of patients. She called the approval a great milestone. Carmen Pérez Casas added that scientific advances, political will, and funding are now in place to curb HIV, stating that the world now has the tools.