The key facts

  • The FDA granted tentative approval to Dr. Reddy's Laboratories' generic of lenacapavir
  • The price is $40 per person per year in 120 countries under a September 2025 agreement between Unitaid, Wits RHI, CHAI and Dr. Reddy's
  • The original Gilead drug costs about $28,000 per year in the US and showed efficacy of more than 99.9% in clinical trials

Generic version of breakthrough drug receives FDA approval

The US Food and Drug Administration (FDA) on Monday granted tentative approval to a cheap version of lenacapavir — an injection for HIV prevention administered twice a year. The approval was announced by the Indian company Dr. Reddy's Laboratories, the generic's manufacturer, and the global initiative Unitaid. The approval is tentative and was issued under an expedited procedure that allows the use of already existing data, Unitaid said.

Price and coverage

The generic will be available at a price of $40 per person per year in 120 countries. That price is fixed in an agreement announced in September 2025 between Unitaid, the African research institute Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy's. According to Carmen Perez Casas, senior strategic HIV adviser at Unitaid, the price is comparable to the cost of daily pills for HIV prevention.

From the original to the generic

Lenacapavir was developed by the American company Gilead Sciences and approved in June 2025 after showing efficacy of more than 99.9% in large clinical trials. In the US, the original drug costs about $28,000 per year, although insurance reduces patients' costs — this was the main obstacle to its widespread use. In late 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy's. Even before the generic appeared, according to Unitaid, more than 125,000 people in 10 African 'early adopter' countries had already started taking Gilead-made lenacapavir.

Why it matters

A twice-yearly injection may be a more effective form of pre-exposure prophylaxis (PrEP) than daily pills, which were approved in the US in 2012 and work only when taken consistently. Before lenacapavir, there was cabotegravir, approved in 2021, which required injections every two months. The journal Science named lenacapavir the 2024 'Breakthrough of the Year,' highlighting research into the HIV capsid protein into which the drug embeds itself. At the same time, Perez Casas emphasized that the main work still lies ahead — moving from approval to rollout: according to her, about 1.2 million people were infected with HIV last year, and Unitaid is already working with governments on country-level implementation programs.