FDA approves generic HIV shot costing $40 a year
The new lenacapavir formulation will be available in 120 countries, offering a cheaper alternative to the $28,000 original drug.
By Camila Herrera ·
The U.S. Food and Drug Administration approved a generic version of the HIV prevention drug lenacapavir this week. The new formulation costs $40 per patient annually and will be distributed in 120 countries. This price tag is a fraction of the original cost, which stands at approximately $28,000 per year in the United States before insurance discounts.
Dr. Reddy’s Laboratories and Unitaid announced the approval. The Indian pharmaceutical company manufactures the generic version. Deepak Sapra, head of pharmaceutical services at Dr. Reddy’s, described the milestone as a moment of immense pride. He stated that creating an affordable, long-acting injectable required strong scientific capabilities and manufacturing experience to meet an urgent need for access.
Lenacapavir is recommended by the World Health Organization to prevent HIV infection. The treatment requires two injections per year. According to available data, the drug reduces the risk of HIV transmission by 99.9%. It serves as an alternative to daily oral pills and other short-duration preventive options. The World Health Organization notes that this is the first preventive therapy authorized with this specific indication that can be administered every six months.
Gilead developed the original lenacapavir and received FDA approval in June 2025. By late 2024, Gilead granted licenses to six pharmaceutical companies to produce generic versions. These agreements are voluntary and royalty-free. The licenses cover production and supply in roughly 120 countries. The pricing agreement was signed by Dr. Reddy’s, Unitaid, Wits RHI, and CHAI.
Availability dates vary by country. The timeline depends on local regulatory authorities and whether the nation is included in Gilead’s voluntary licenses. In some licensed countries, distribution could begin within weeks of regulatory approval. In others, widespread supply is expected by 2027. The approval allows the drug to reach markets with lower resources more quickly and at a lower cost.
