FDA grants tentative approval for generic HIV prevention shot
Generic HIV prevention injection gains FDA approval, poised to lower costs and expand global access.
A pharmacist holds a vial of the HIV prevention medicine lenacapavir in Cape Town, South Africa. Nardus Engelbrecht/AP (Photo via STAT)
The U.S. Food and Drug Administration has issued a tentative approval for the first generic version of lenacapavir, a twice-yearly injectable medication used for HIV prevention. This regulatory status allows the medication to be distributed in 120 low- and middle-income countries while the originator product remains under patent in the United States.
The generic version is manufactured by the India-based firm Dr. Reddy’s Laboratories. Under an agreement reached in September 2025, the medication is expected to be available at a cost of $40 per person per year. This price point is comparable to the cost of daily oral pills used for pre-exposure prophylaxis, or PrEP.
Carmen Pérez Casas, the HIV lead for Unitaid, described the approval as a significant achievement in expanding access to treatment. Carolyn Amole, HIV program lead for the Clinton Health Access Initiative, stated that scaling the medication could reach 20 million people globally and potentially help bring an end to the HIV epidemic.
The FDA designation serves to ensure quality standards for drugs provided to other nations by the U.S. government and can help accelerate regulatory approvals in those countries. Initial supplies are projected to reach target regions before the end of 2026, with broader availability expected to follow in 2027.