FDA Tentatively Approves First Generic Lenacapavir Injection for HIV Prevention at $40 a Year

The U.S. Food and Drug Administration granted tentative approval on 2 November 2026 to the first generic version of injectable lenacapavir for HIV pre-exposure prophylaxis.

Dr. Reddy’s Laboratories of Hyderabad, India, will manufacture the twice-yearly injection. Under existing agreements, it will be available at about $40 per person per year in the 120 low- and middle-income countries covered by Gilead Sciences’ voluntary licensing programme. Initial supplies are expected to reach countries before the end of 2026, with broader availability in 2027.

Gilead’s originator product, marketed as Yeztugo in the United States, received FDA approval for prevention in June 2025. Its list price in the U.S. is $28,218 per year. The generic approval arrived only 16 months later. Partners including Unitaid, the Clinton Health Access Initiative, and Wits RHI said the timeline is far shorter than the multi-year processes typical for major HIV innovations.

Tentative approval is the FDA’s standard designation for a generic while the originator remains under patent. It does not allow sale in the United States, but it qualifies the product for purchase by the U.S. government and supports procurement for eligible countries. Dr. Reddy’s combined the prevention and treatment indications in a single application and used the 505(b)(2) pathway, which helped secure priority review.

Lenacapavir is a capsid inhibitor given by subcutaneous injection once every six months after an initial loading dose. In Gilead’s PURPOSE 1 trial, zero infections occurred among 2,134 participants receiving the drug. PURPOSE 2 recorded two infections among 2,179 participants. Efficacy in the trials exceeded 99 percent in the reported analyses. More than 125,000 people in Africa have already started on the originator product.

Neil Buddy Shah, CEO of the Clinton Health Access Initiative, said the approval brings the injection closer to millions of people at $40 a year and shows what is possible when access is prioritised from the start. Deepak Sapra of Dr. Reddy’s noted the regulatory strategy that shortened the usual timeline.

The $40 price applies only in the licensed countries. It covers the drug itself; additional costs for delivery, training, and health-system integration will vary by country. Unitaid and partners have worked on the licensing and pricing agreements since 2025 to prepare for generic supply.

For health systems in the 120 countries, the twice-yearly schedule reduces the need for daily pills and frequent clinic visits. That can improve adherence in settings where daily oral PrEP has faced logistical barriers. The injection must still be administered by trained health workers, so rollout depends on supply chains, cold-chain or storage capacity where required, and clinic infrastructure.

Gilead’s voluntary licence allows generic manufacturers to produce for the listed countries while the company retains rights in high-income markets. The rapid generic approval does not affect U.S. or European pricing or availability of the originator. It does expand the pool of potential suppliers for global health purchasers.

The FDA’s action on 2 November completes one regulatory step. Actual volumes, shipping schedules, and national regulatory clearances in the recipient countries will determine when the first generic doses reach patients. Partners expect the first shipments before the end of the calendar year.