FDA approves generic version of HIV-prevention injection
The announcement was made by Dr. Reddy's Laboratories, the Indian pharmaceutical company that manufactures the generic version, and Unitaid, a global health initiative.
Image from the FDA
The Food and Drug Administration (FDA) approved on Monday a low-cost generic version of lenacapavir, an injectable HIV prevention medication administered twice a year. The authorization represents a step toward facilitating access to this treatment in low-income countries.
The announcement was made by Dr. Reddy's Laboratories, the Indian pharmaceutical company that manufactures the generic version, and Unitaid, a global health initiative. Under the pricing agreement announced in September 2025, the drug will be available for $40 per person per year in 120 countries.
The agreement was signed by Dr. Reddy's, Unitaid, the African health research institute Wits RHI and the Clinton Health Access Initiative (CHAI), with the goal of expanding access to this prevention option.
"This is a moment of immense pride for all of us at Dr. Reddy's," said Deepak Sapra, the company's executive director of Pharmaceutical Services and APIs.
"Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need," he added.
One injection twice a year with more than 99.9% efficacy
Lenacapavir was originally developed by the U.S. pharmaceutical company Gilead and received initial approval in June 2025, after demonstrating an efficacy of over 99.9% in large clinical trials.
The medication is administered via an injection every six months and serves as an alternative to the daily pills used for pre-exposure prophylaxis (PrEP), an HIV prevention method whose first version received U.S. approval in 2012.
Although it does not work like a traditional vaccine—since it does not train the immune system—its administration every six months may make prevention easier compared to an oral treatment that must be taken consistently to remain effective.
However, the high price of lenacapavir had been one of the main obstacles to expanding its use. In the United States, it costs around $28,000 per year, although health insurance plans reduce the amount patients pay.
The availability of a generic version for $40 a year opens up a new avenue for expanding access to this preventive tool, especially in countries with fewer resources.
Licenses for generic manufacturers
In late 2024, Gilead granted voluntary licenses to manufacture lenacapavir to six generic drug manufacturers, including Dr. Reddy's Laboratories.
Unitaid noted in its press release that more than 125,000 people in 10 African countries who initially adopted the treatment had already begun using Gilead's lenacapavir, even before generic versions became available.
According to Dr. Reddy's, the FDA authorization was granted under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), a U.S. program designed to combat the HIV/AIDS epidemic.
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