FDA Approves First Generic Long-Acting HIV Prevention Injection

The cost of long-acting HIV prevention could fall significantly after the United States Food and Drug Administration (FDA) approved the first generic version of Lenacapavir, paving the way for wider access to the drug in Uganda and 119 other low- and middle-income countries.

The generic injection has been developed by Indian pharmaceutical company Dr. Reddy’s Laboratories with financial, technical and regulatory support from Unitaid, Wits RHI and the Clinton Health Access Initiative (CHAI). 

Under a partnership agreement that combined an early pricing commitment with financial and technical support to accelerate development and market entry, Dr. Reddy’s Lenacapavir injection is expected to cost 40 US dollars per person annually in the 120 countries covered by Gilead Sciences’ voluntary licensing arrangement. Uganda is among the eligible countries.

Lenacapavir is a long-acting injectable used for HIV prevention, offering an alternative to daily oral prevention medication. Commenting on the approval, Dr Philippe Duneton, Executive Director of Unitaid, said early investments and risk-taking by partners were helping shorten the time between scientific breakthroughs and access to medicines in low- and middle-income countries.

“With best-in-class HIV treatment, we delivered in four years what used to take ten. Now, with Lenacapavir, we have helped shorten that timeline to just over a year. For young women in Africa, this translates into faster access to a groundbreaking HIV prevention option, with the potential to avert countless infections and drive meaningful change in the HIV response,” Duneton said.

The development follows the FDA’s approval of Gilead Sciences’ original Lenacapavir product for HIV prevention in June 2025. Gilead had earlier granted voluntary licences to six generic manufacturers, including Dr. Reddy’s, in late 2024 to facilitate production and distribution in selected low- and middle-income countries. The partners adopted a regulatory approach that combined Lenacapavir’s prevention and treatment indications in a single application, enabling Dr. Reddy’s to seek priority review by the FDA. 

The approach, alongside targeted financial and technical support, helped accelerate the regulatory process, which would ordinarily take several years. However, access to an affordable drug alone will not guarantee successful uptake, according to Prof Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand.

“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. Bringing these elements together will be critical to ensuring equitable access and impact,” Mullick said. Even before the generic version becomes available, more than 125,000 people in 10 early-adopter African countries, including Uganda, have already started using Gilead’s Lenacapavir, according to the statement.

The generic version is expected to expand access by offering a substantially cheaper option, although its actual rollout will depend on national regulatory processes, procurement arrangements and the readiness of health systems to deliver the injection.