Dr. Reddy’s Laboratories has received tentative FDA approval for a generic version of the twice-yearly HIV prevention injection, aimed at increasing access in low- and middle-income countries.
The U.S. Food and Drug Administration (FDA) has granted tentative approval to the first generic version of lenacapavir, a twice-yearly injectable medication used for HIV prevention. Developed by Dr. Reddy’s Laboratories, the approval comes 16 months after the FDA approved the originator product, Yeztugo, which was developed by Gilead Sciences in June 2025.
Under a landmark pricing agreement announced in September 2025, the generic lenacapavir injection is expected to cost US$40 per person per year. This price is intended to match the cost of daily oral pre-exposure prophylaxis (PrEP) pills. The generic version will be available in 120 low- and middle-income countries included in Gilead’s voluntary license.
According to reports, the generic version cannot be marketed in the United States because the brand-name version, Yeztugo, remains protected under active patent laws. In the U.S., Yeztugo has a list price of $28,218 per year before insurance adjustments. Gilead representatives stated that this cost is comparable to other available forms of PrEP.
Initial supplies of the generic are expected to reach countries by the end of 2026, with broader availability anticipated in 2027. Zambia is expected to be among the first countries to receive supplies.
Dr. Reddy’s Laboratories received financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the development and market entry of the generic.
To expedite the process, Dr. Reddy’s utilized a novel regulatory strategy by combining lenacapavir’s prevention and treatment indications into a single application. This allowed the company to file through the FDA’s 505(b)(2) pathway and secure a priority review. This approach helped compress a process that typically takes many years.
While the approval is a significant milestone, health experts have noted that medication availability is only one component of access. Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, stated, "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."
Dr. Neil Buddy Shah, CEO of CHAI, noted that the injection offers a convenient alternative to daily pills, stating, "For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely."
Before the generic was approved, over 125,000 people in 10 early adopter African countries had already started using Gilead’s lenacapavir.
Common side effects associated with lenacapavir include nausea, headache, and reactions at the injection site. Medical guidelines require individuals to undergo HIV testing before starting the medication and before receiving subsequent shots. Instances of drug-resistant HIV have been recorded when the medication was administered to individuals with undiagnosed HIV infections.
Sources
This article was drafted with AI assistance and checked against the sources above. Company claims are reported as claims. Cover image is AI-generated.
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