FDA Approves Generic Twice-a-Year HIV Prevention Shot
The generic version of lenacapavir is expected to reach some low- and middle-income countries within weeks at about $40 a year per person.
Updated on Nov. 2, 2026 in Sexual Health
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The U.S. Food and Drug Administration approved a generic version of lenacapavir, the world's only twice-a-year shot to prevent HIV. Generic lenacapavir cannot be sold in the United States because the brand-name version, Yeztugo, remains under patent.
Why it matters
Demand for lenacapavir has outstripped supply in low- and middle-income countries, and an FDA approval can speed regulatory approval in many other countries. The generic version is intended to expand access to a prevention option that has been limited to a single supplier until now.
The generic is projected to cost $40 a year per person, compared with a U.S. list price of $28,218 a year for brand-name Yeztugo before insurance. Generic versions from other manufacturers have not yet received FDA approval, and the FDA's approval of this generic remains tentative while the originator holds a patent.
The players
Gilead Sciences
Gilead Sciences is the American biopharmaceutical company that had been the sole supplier of lenacapavir and holds the patent on the brand-name Yeztugo.
Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company that developed the generic version of lenacapavir.
U.S. Food and Drug Administration
The U.S. Food and Drug Administration is the federal agency responsible for approving drugs and medical products sold in the United States.
Unitaid
Unitaid is a global health agency hosted by the World Health Organization that works to improve access to health products in low- and middle-income countries.
The details
The generic was developed by Dr. Reddy's Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI. Gilead Sciences, which had been the sole supplier, established royalty-free licensing agreements with six generic manufacturers last year.
Timeline
Last year: Gilead established royalty-free licensing agreements with six generic manufacturers and the brand-name Yeztugo was approved.
November 2, 2026: The FDA approved generic lenacapavir, announced Monday morning.
Within weeks: Generic lenacapavir is expected to become available in some low- and middle-income countries.
Access Landscape
The generic approval follows Gilead's royalty-free voluntary licensing agreements with six manufacturers established last year, which covered sub-Saharan Africa, Asia and Latin America. The approval extends that licensing model from voluntary agreements into an FDA-cleared product.
For people in low- and middle-income countries, the generic is projected to cost about $40 a year, making the prevention shot potentially available where the brand-name price would be out of reach. Anyone considering the shot must first be tested for HIV and retested with each injection.
The takeaway
Expanded generic access could change who can realistically use twice-a-year HIV prevention, though availability will depend on how quickly the drug reaches individual countries. Anyone interested should talk to a health provider about testing and eligibility.
What happens next
Generic lenacapavir is expected to become available in some low- and middle-income countries within weeks, and generic versions from other manufacturers still await FDA approval.
Further reading
For broader context on prevention options, see Sexual Health coverage.
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