First Generic Lenacapavir Wins Tentative FDA Approval: $40 a Year for HIV Prevention Across 120 Countries, Not for Sale in the U.S.
Dr. Reddy's Laboratories, together with the Clinton Health Access Initiative (CHAI) and other partners, announced on November 2 that the U.S. Food and Drug Administration has granted tentative approval to the company's injectable lenacapavir, the first generic version of the twice-yearly HIV prevention shot. The approval was granted under the FDA's President's Emergency Plan for AIDS Relief (PEPFAR) program.
The generic will be supplied at $40 per person per year across the 120 low- and middle-income countries covered by Gilead Sciences' voluntary licensing program, for HIV pre-exposure prophylaxis (PrEP). The partners said first supplies are expected to reach countries by the end of 2026, with broader availability in 2027.
Tentative approval is the FDA's standard designation for a generic that meets its standards while the originator product is still under patent: it cannot be sold in the United States until the patents and exclusivity expire. Gilead's brand-name version, Yeztugo, was approved for HIV prevention in June 2025, remains patent-protected, and is the only lenacapavir prevention product sold in the U.S.
Lenacapavir was developed by Gilead and showed more than 99.9 percent effectiveness in large clinical trials. Dr. Reddy's combined the drug's prevention and treatment indications in a single application filed through the FDA's 505(b)(2) pathway and received priority review, which targets a decision within six months; the tentative approval came about 16 months after the brand product was approved.
Unitaid and South Africa's Wits Reproductive Health and HIV Institute also supported the generic's development.
(Source: Dr. Reddy's Laboratories and Clinton Health Access Initiative announcement)
Published by GSM · USA (original Chinese edition)
Photo: 白宫南草坪悬挂的艾滋病红丝带（资料图，2021年世界艾滋病日）。白宫官方照片，公共领域，经 Wikimedia Commons。 / The AIDS red ribbon displayed on the White House North Portico for World AIDS Day 2021 (file photo). Official White House photo, public domain, via Wikimedia Commons.
