FDA approves generic twice-yearly HIV prevention shot priced at $40 a year

Approval and announcement

The US Food and Drug Administration (FDA) approved a generic version of lenacapavir on Monday, 2 November 2026. Dr. Reddy's Laboratories, the Indian company that makes the generic, and Unitaid, an international initiative that works to supply medicines in low- and middle-income countries, announced the approval. Lenacapavir is given as an injection twice a year and is used as pre-exposure prophylaxis (PrEP) against HIV. Other preventive treatments require a tablet taken every day. The injection reduces the risk of HIV transmission by 99.9%.

Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative, said the generic could help scale access to the 20 million people worldwide who need PrEP.

“And if we scale to those levels, we can actually begin to bring an end to the HIV epidemic.”

How the drug reached this point

Gilead Sciences developed lenacapavir and, at the end of 2024, granted licences to make generic versions to six pharmaceutical companies, Dr. Reddy's among them. The FDA approved the original lenacapavir in June 2025. In September 2025, Dr. Reddy's, Unitaid, the African health research institute Wits RHI and the Clinton Health Access Initiative (CHAI) announced the pricing agreement covering the 120 countries where the drug is to be available. Unitaid said the first doses are expected before the end of 2026, with wider availability in 2027. Monday's approval of the generic version came after these steps.

Price and the US market

The generic is projected to cost $40 per patient per year, the same as the daily oral pills currently used for prevention, while the injection requires far fewer doses. In the United States, Gilead's brand-name version, Yeztugo, has a list price of $28,218 per year before insurance adjustments. Gilead representatives say that cost is comparable to other forms of PrEP. Before generics existed, the high price was a considerable obstacle to wider use of the drug. Because Yeztugo remains protected by active patents, the generic cannot be marketed in the United States.

Generic, 120 countries (projected)40

Yeztugo, US list price before insurance28,218

Generic, 120 countries (projected)

40 USD

Yeztugo, US list price before insurance

28218 USD

Data from the article text

Epidemic context and what comes next

World Health Organization data cited in the coverage show that 41 million people were living with HIV last year, and 570,000 died from HIV-related causes. Unitaid's Carmen Pérez Casas estimated that 1.2 million people contracted HIV last year and said the injection offers close to 100% protection with two doses a year. She also said that people who do not take a daily tablet cannot be protected against HIV. Pérez Casas warned that the real success of the drug is still to come, while Amole's program estimates that 20 million people worldwide need PrEP.