FDA tentatively approves generic twice-yearly HIV prevention shot for poorer countries

As of 6:58 a.m. ET, Tuesday, Nov. 3, 2026

The U.S. Food and Drug Administration has given tentative approval to a generic version of lenacapavir, the twice-a-year HIV prevention shot. The generic cannot be sold in the United States. It is meant for low- and middle-income countries, where its backers say it will cost $40 per person per year.

The generic is made by India's Dr. Reddy's Laboratories. The tentative approval was announced Monday by the company and by the global health agency Unitaid, which helped pay for and speed up the drug's development.

What "tentative" means

Tentative approval is the FDA's standard designation for a generic drug while the original version is still under patent, Unitaid said. The brand-name version, Gilead Sciences' Yeztugo, remains protected by a patent in the United States, the Associated Press reported. Its U.S. list price before insurance is $28,218 a year.

Reuters reported that tentatively approved drugs meet all of the FDA's safety, efficacy and quality standards but cannot yet be sold in the U.S. because of patent or exclusivity issues. According to Unitaid, the designation allows the U.S. government to buy the drug for its HIV programs abroad. The FDA approved the drug under a longstanding practice meant to ensure the quality of HIV drugs the U.S. government provides to other countries, the AP reported.

Individual countries still have to approve the generic, Science reported. But FDA approval often speeds those reviews. "There are some countries who would be able to fast-track regulatory approvals based on a reliance mechanism on the US FDA," Jessica Burry, a technical officer at Unitaid, told Reuters.

$40 a year in 120 countries

Under an agreement announced in September 2025, Dr. Reddy's will sell the shot for $40 per person per year in the 120 low- and middle-income countries covered by Gilead's voluntary license, Unitaid said. The AP reported that this is the same price as the daily HIV prevention pills available now. Gilead granted royalty-free licenses to six generic makers in 2024. Dr. Reddy's is the only one of the six to have received FDA approval so far, the AP and Reuters reported.

Unitaid said the approval came 16 months after the FDA approved Gilead's original product for HIV prevention in June 2025. That speed came partly because Dr. Reddy's combined the drug's prevention and treatment uses in a single application, which let it seek a priority review.

In two major studies of people at high risk, the shots nearly eliminated new infections, the AP reported. Common side effects include injection-site reactions, headache and nausea. People must be tested for HIV before starting the drug and before each injection, because drug-resistant HIV has been found in people who used it while unknowingly infected.

Supplies expected by year's end

Unitaid said initial supplies of the generic are expected to reach countries before the end of 2026, with wider availability in 2027. Zambia could be among the early recipients, Unitaid told Reuters.

More than 125,000 people in 10 African countries have already started on Gilead's version, Unitaid said. "We are having supply challenges that generics will solve," Carolyn Amole of the Clinton Health Access Initiative, which helped negotiate the price, told Science. CHAI hopes 20 million people worldwide will be using the shot by 2030, Science reported.

"The work is not done," Amole told the AP. "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. But this is a great milestone."