The U.S. Food and Drug Administration has granted Dr. Reddy’s Laboratories tentative approval for a generic version of lenacapavir, a twice-yearly HIV-prevention injection. The designation can help support regulatory and purchasing decisions in eligible countries, but it does not permit sales in the United States while the branded product remains protected by patent. Reuters reported the tentative decision and its potential role in overseas procurement; The Associated Press described the FDA’s designation as part of a longstanding practice for HIV-related medicines supplied abroad.
The price depends on where the generic is available
Global health agencies expect the generic to cost about $40 per person per year in countries where it is supplied, according to Reuters. That compares with a U.S. list price of $28,218 a year for branded Yeztugo, before insurance, reported by The Associated Press. The lower figure is an expected price, not confirmation that the drug is already available in every eligible country.
Gilead Sciences signed non-exclusive, royalty-free licensing agreements in October 2024 with six manufacturers to produce and sell generic lenacapavir in 120 high-incidence, resource-limited countries, subject to regulatory approvals. The company’s announcement identifies Dr. Reddy’s as one of the licensees; Reuters reported it was the first of the six to receive tentative FDA approval. Gilead’s announcement describes the scope of the agreements, while Reuters reported the FDA decision.
Regulatory clearance is not the same as a broad rollout
Some countries may use the FDA assessment to speed their own regulatory or purchasing decisions, but countries with separate approval procedures may take longer, Reuters reported. Initial supplies are expected to reach a few low-income countries by the end of 2026, with wider distribution across eligible countries anticipated in 2027, according to the same report. The other five licensed manufacturers had not received FDA approval for their generic versions at the time of the report.
Use still requires HIV testing
People starting lenacapavir need an HIV test before treatment and another with each injection. The Associated Press reported that drug-resistant HIV has been identified in cases where the medicine was used by people with undiagnosed infection. The AP also reported injection-site reactions, headache, and nausea among possible side effects, and said two studies in people at high risk of HIV found that the injection nearly eliminated new infections. The Associated Press is the source for these safety and trial details.
