The Food and Drug Administration (FDA), the US regulatory body, granted provisional approval to the first generic version of lenacapavir. This medication is an injection administered semi-annually and offers near-complete protection against HIV infection.
The generic, produced by the Indian pharmaceutical company Dr. Reddy’s Laboratories, cannot be marketed in the US due to patent protection of the original drug. However, it can be acquired by the American government for PEPFAR, a program aimed at combating HIV abroad.
Both Dr. Reddy’s and Unitaid, a global health initiative that supported the development of the generic, aim to ensure this medication reaches low- and middle-income nations.
Dr. Reddy’s is one of six pharmaceutical companies authorized by Gilead Sciences, the creator of lenacapavir, to produce the lower-cost version. In 2024, licenses were issued to companies located in Asia and North Africa. Currently, only Dr. Reddy’s has FDA approval, but all six can distribute the medicine in 120 countries after obtaining the necessary permits. This list includes areas with high HIV rates, such as South Africa, Lesotho, Botswana, and Zimbabwe.
The annual cost of Dr. Reddy’s generic will be 40 dollars per patient. This price was established in 2025 through an agreement signed with three health entities: Unitaid, the Clinton Health Access Initiative (CHAI), and the South African institute Wits RHI. The first doses are expected to reach the countries by the end of 2026, with supply expansion anticipated in 2027.
Lenacapavir, which is injectable and applied twice a year, may represent a more effective alternative for HIV pre-exposure prophylaxis (PrEP) compared to daily pills, whose effectiveness depends on constant adherence.
The substance had already been marketed by Gilead since 2022 for HIV treatment. In 2025, it was approved in the US for prevention purposes, following clinical trials that demonstrated nearly 100% protection. In one of these studies, none of the treated women contracted the infection, and in another, only two of the 2,179 participants who used lenacapavir contracted the virus.
In 2024, Science magazine named lenacapavir the 'Advance of the Year,' recognizing the fundamental research that underpinned the drug. However, the high cost in the US, reaching about 28 thousand dollars annually, posed a major obstacle to its widespread availability.
According to Unitaid, even before the arrival of the generic, more than 125,000 individuals in ten African countries were already using Gilead-manufactured lenacapavir on an early basis. The organization emphasizes that the generic obtained 'provisional approval' from the FDA, which is the standard status for generics while the original product remains under protection.
