FDA tentatively approves first generic lenacapavir for HIV prevention in lower-income countries

The FDA has granted tentative approval to the first generic version of injectable lenacapavir, a twice-yearly HIV pre-exposure prophylaxis (PrEP) option, according to a news release from Unitaid, one of the healthcare organizations involved.

Tentative approval is the FDA’s standard designation for a generic while the originator product remains under patent. It does not allow the generic to be sold in the United States, but it does make the product eligible for purchase by the U.S. government.

The approval comes 16 months after the FDA approved Gilead Sciences' originator lenacapavir for HIV prevention in June 2025.

Gilead markets the product as Yeztugo in the United States, and it carries a list price of $28,218 per year, according to Drugs.com.

The generic is manufactured by Dr. Reddy’s Laboratories and is intended for the 120 low- and middle-income countries covered by Gilead’s voluntary licensing program. Initial supplies are expected to reach countries by the end of 2026.

“More than 125,000 people in Africa have already started on lenacapavir, and today’s approval brings us closer to making it available to millions more for just $40 a year,’ Neil Buddy Shah, M.D., CEO of CHAI, said in the news release. “Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritize access from the start. This should be the new standard for global health.”

How the generic lenacapavir timeline was shortened

The path to approval began in late 2024, when Gilead granted voluntary licenses for lenacapavir to six generic manufacturers:

• Dr. Reddy's Laboratories Limited
• Emcure Pharmaceuticals Limited
• Eva Pharma for Pharmaceutical Industries S.A.E.
• Ferozsons Laboratories Limited
• Hetero
• Mylan Laboratories Limited

In September 2025, Unitaid, Wits RHI, a research institute of the University of the Witwatersrand, and the Clinton Health Access Initiative (CHAI) reached a pricing agreement with Dr. Reddy's that paired an early pricing commitment with financial, technical and regulatory support.

Lenacapavir currently has two indications: HIV prevention and HIV treatment. Dr. Reddy’s combined both in one application filed through the FDA’s 505(b)(2) pathway. That allowed Dr. Reddy’s to request and secure a priority review.

What generic lenacapavir means for HIV prevention access

The approval lands as global prevention programs absorb funding cuts. In 2025, new HIV infections fell to approximately 1.2 million. However, the number of people who received PrEP at least once across 62 countries fell from 3.3 million in 2024 to 2.1 million in 2025, according to UNAIDS data.

Next steps for lenacapavir country introduction

The partners framed the tentative approval as a regulatory foundation rather than an endpoint. It can help accelerate the remaining steps, support national regulatory approvals and allow countries to move faster toward introduction, according to the release.

Unitaid, Wits RHI and CHAI said they are coordinating with national governments, the Global Fund, the U.S. Bureau of Global Health Security and Diplomacy, the Gates Foundation and community groups on rollout, including collecting real-world data on reaching underserved populations.

“Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough,” Saiqa Mullick, Ph.D., a professor and director of implementation science at Wits RHI, said in the release. “Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them and communities that are engaged as partners in their introduction and scale-up.”