US approves generic version of drug to prevent HIV

The decision was announced by Indian pharmaceutical company Dr. Reddy's Laboratories, manufacturer of the generic, and by Unitaid, an international health organization that supported the development of the drug.

The generic will cost $40 per person per year in the 120 low- and middle-income countries included in Gilead's licensing agreement. The price was set in an agreement announced in September 2025 between Dr Reddy's, Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI).

Lenacapavir is administered via two injections per year and has demonstrated greater than 99.9% efficacy in preventing HIV in large clinical studies. The drug is used as pre-exposure prophylaxis, known by the acronym PrEP.

“This is an immensely proud moment for all of us at Dr. Reddy's,” Deepak Sapra, executive of the company's pharmaceutical services division, said in a statement.

“Developing and manufacturing a complex, long-acting injectable like lenacapavir at an affordable price required strong scientific capacity and manufacturing expertise to meet the urgent need to expand access,” he said.

“Unitaid’s decision to take risks from the beginning is helping to shorten the gap between a scientific breakthrough and effective access in countries,” said Philippe Duneton, the organization’s executive director.

In June 2025, the FDA approved the original version of lenacapavir, developed by the pharmaceutical company Gilead. In the United States, the list price of the drug is around US$28,000 per year, before insurance coverage, a value that makes expanding access difficult.

At the end of 2024, Gilead granted voluntary licenses to six pharmaceutical companies to produce generic versions of lenacapavir, including Dr. Reddy's.

According to Unitaid, more than 125,000 people in ten African countries that adopted the treatment early have already started using lenacapavir manufactured by Gilead, even before the arrival of generic versions.