FDA Clears a $40 Twice-Yearly HIV Prevention Shot for Poorer Countries

Keypoints:

• The FDA gave tentative approval to the first generic twice-yearly HIV prevention shot
• Dr. Reddy's expects a price of $40 per person per year
• The brand version lists at around $28,000 a year in the US
• First supplies could reach a few low-income countries by the end of 2026
• The generic can't be sold in the US because of patents

The FDA has given tentative approval to the first generic version of lenacapavir, a twice-yearly shot that protects people from HIV. The generic comes from India's Dr. Reddy's Laboratories, and global health groups say it will cost about $40 per person per year in 120 low and middle income countries. In the US, the branded version, Yeztugo from Gilead, lists at around $28,000 a year.

That price gap is the whole story. Lenacapavir was approved in the US in June 2025 and proved more than 99.9 percent effective in large trials, but the cost kept it out of reach for most of the people who need it. Gilead licensed the drug to six generic makers in late 2024, and Dr. Reddy's is the first of them to clear the FDA. Unitaid, the Clinton Health Access Initiative and Wits RHI backed the effort. The approval came about 16 months after the original, which is far faster than these things usually go.

A quick note on the wording. Tentative approval is what the FDA gives a generic while the original is still under patent. It means the drug meets the agency's safety, efficacy and quality standards, but it can't be sold in the US yet. Its real value is for other countries, since procurement agencies and national regulators can lean on the FDA's review to move faster on their own approvals and purchases.

Timing looks like this. Unitaid says first supplies could reach a few low income countries by the end of 2026, and Dr. Reddy's expects the wider rollout in 2027. Before generics even arrived, more than 125,000 people in ten early adopter African countries had already started Gilead's version. Another Indian company, Hetero, is working with the Gates Foundation on its own generic.

The timing matters because prevention programs are dealing with funding cuts, and new HIV infections were still around 1.2 million in 2025. Experts also say an affordable drug alone is not enough, since countries still need clinics, trained staff and ways to reach people. A cheap shot is a big step, but getting it into arms is the next challenge.