FDA approves generic version of HIV-prevention shot lenacapavir

On November 2, 2026, the U.S. FDA tentatively approved Dr. Reddy's Laboratories' generic version of lenacapavir, a twice-yearly HIV-prevention shot proving over 99.9% effective in trials. Brokered by Unitaid, CHAI, and Wits RHI under Gilead's voluntary licensing, the $40 annual treatment targets 120 low- and middle-income countries—drastically cutting the typical decade-long lag for breakthrough medicine access in developing nations.

FDA regulatory status of generic lenacapavir

• ▪The U.S. FDA approved Dr. Reddy's generic lenacapavir under an accelerated pathway and a longstanding practice designed to evaluate HIV drugs provided to foreign countries by the U.S. government
• ▪The U.S. Food and Drug Administration granted tentative approval on November 2, 2026 to a generic version of the twice-yearly HIV-prevention shot lenacapavir developed by Dr. Reddy's Laboratories
• ▪Generic versions of lenacapavir produced by other licensed manufacturers have not yet received U.S. Food and Drug Administration approval

Generic lenacapavir development and pricing

• ▪The Clinton Health Access Initiative estimates that affordable generic lenacapavir could help scale pre-exposure prophylaxis to 20 million people globally at risk of HIV exposure
• ▪Generic lenacapavir manufactured by Dr. Reddy's Laboratories will be priced at $40 per person per year in 120 low- and middle-income countries under a September 2025 pricing agreement brokered by Unitaid
• ▪Dr. Reddy's Laboratories' generic version of lenacapavir was developed through a partnership between Dr. Reddy's Laboratories, Unitaid, the Clinton Health Access Initiative, and African health research institute Wits RHI

Rollout of generic lenacapavir

• ▪Unitaid is currently collaborating with national governments and organizational partners to support country-led rollouts of lenacapavir
• ▪More than 125,000 people across 10 early-adopter African countries have initiated Gilead Sciences' brand-name lenacapavir ahead of generic availability

Gilead's development and generic licensing

• ▪Gilead Sciences previously served as the sole supplier of lenacapavir, with demand exceeding supply across low- and middle-income countries
• ▪U.S. pharmaceutical company Gilead Sciences originally developed lenacapavir and secured its initial regulatory approval in June 2025
• ▪In late 2024, Gilead Sciences signed royalty-free voluntary licensing agreements with six generic manufacturers, including Dr. Reddy's Laboratories, covering specified countries in sub-Saharan Africa, Asia, and Latin America

Lenacapavir clinical profile

• ▪Common side effects of lenacapavir include injection site reactions, headache, and nausea, and patients must undergo rapid HIV testing prior to starting the medication and before each injection
• ▪Lenacapavir proved more than 99.9% effective in large clinical trials and nearly eliminated new HIV infections among high-risk individuals
• ▪Lenacapavir requires two injections a year and targets the HIV capsid protein, contrasting with daily oral PrEP pills approved in 2012 and injectable cabotegravir approved in 2021 for bi-monthly use

Global HIV statistics

• ▪More than 40 million people globally have died from HIV-related causes over four decades of the epidemic
• ▪According to World Health Organization and Unitaid data, 41 million people were living with HIV globally in 2025, 1.2 million acquired the virus, and 570,000 died from HIV-related causes