FDA Clears First Generic Version of Twice-Yearly HIV Prevention Shot for 120 Countries
The Food and Drug Administration gave tentative approval to Dr. Reddy's generic lenacapavir, a twice-yearly injection to prevent HIV priced at $40 a year in 120 low- and middle-income countries, where the brand-name version carries a U.S. list price of $28,218 a year.
The U.S. Food and Drug Administration has approved the first generic version of lenacapavir, the twice-yearly injection to prevent HIV, developed by Dr. Reddy’s Laboratories of India, according to Health Policy Watch. The tentative approval was announced on Monday by Dr. Reddy’s and Unitaid, a global health agency. Tentative is the FDA’s standard designation for generics while the originator product remains under patent, according to The Associated Press.
A $40-a-year price in 120 countries
The generic is expected to cost $40 per person a year in the 120 low- and middle-income countries covered by the licensing agreement, the same price as daily preventive pills now available. The shots are needed only twice a year, and they nearly eliminated new infections in two large studies of people at high risk, according to The Associated Press.
The brand-name version, Yeztugo, made by Gilead Sciences and approved in June 2025, carries a U.S. list price of $28,218 a year. The generic cannot be sold in the United States because the brand-name product is still protected by a patent. Gilead signed royalty-free licensing agreements in October 2024 with six generic manufacturers, including Dr. Reddy’s, limiting sales of the generics to 120 high-incidence, resource-limited countries, according to Health Policy Watch.
“And if you do not take it, you cannot get protected against HIV,” said Carmen Perez Casas, HIV lead for Unitaid. “With lenacapavir, we are much more hopeful.” Carolyn Amole, who leads the HIV program for the Clinton Health Access Initiative, said, “We could help to scale this to the 20 million people around the world who need PrEP,” the prescription medicine taken by people at risk of HIV before exposure.
According to the World Health Organization, 41 million people worldwide were living with HIV and 570,000 died from HIV-related causes last year, according to The Associated Press.
Testing still required with each shot
Common side effects with lenacapavir include injection site reactions, headache and nausea. People must be tested for HIV before starting the drug and with each injection, because drug-resistant HIV has been found when the drug was used by people with an undiagnosed HIV infection, according to The Associated Press. “For any kind of PrEP, you need to have HIV testing in advance,” said Saiqa Mullick, director of implementation science with Wits RHI.
Generic lenacapavir should start to become available in some places within weeks, although it could take longer in countries that require their own approval processes first, according to The Associated Press. Generics from the other manufacturers have yet to be approved by the FDA. Zambia is likely to be one of the first countries to receive supplies, according to Health Policy Watch.
“The work is not done. Now, we need the funding to actually buy it for everyone who needs it and then we need to do the hard work of getting it to the millions of people who need it and want it,” Amole said. “But this is a great milestone.”
Reporting based on coverage by The Associated Press and Health Policy Watch.
