The FDA has granted tentative approval to Dr. Reddy’s Laboratories for the first generic version of lenacapavir, the twice-yearly injection for HIV prevention, according to a Nov. 2 news release from the Clinton Health Access Initiative, one of the partners that supported its development. The decision came 16 months after the FDA approved Gilead Sciences’ originator product, Yeztugo, in June 2025.
Tentative approval is the FDA’s standard designation for generics while the originator product remains under patent, and it allows the U.S. government to procure the drug, according to the release. The generic is not approved for sale in the U.S. market under that designation. Dr. Reddy’s lenacapavir will be available for $40 per person per year in the 120 low- and middle-income countries covered by Gilead’s voluntary license, the partners said, with first supplies expected to reach countries by the end of 2026 and broader availability in 2027.
The partners said a novel regulatory strategy shortened the timeline. Dr. Reddy’s combined lenacapavir’s prevention and treatment indications in a single application, allowing it to file through the FDA’s 505(b)(2) pathway and request priority review, which targets a decision within six months. Gilead began granting voluntary licenses to six generic manufacturers, including Dr. Reddy’s, in late 2024, and Unitaid, Wits RHI and CHAI provided financial, technical and regulatory support.
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