FDA Clears $40 Generic HIV Prevention Shot
The approved generic version of lenacapavir costs a fraction of the original brand name drug, which is priced at $28,000 annually in the United States.
By Yasmin Nasser ·
The U.S. Food and Drug Administration approved a generic version of lenacapavir this week. The new injection costs $40 per year for each patient, a stark contrast to the $28,000 annual price tag of the original drug in the U.S. market.
This approval covers a medication that reduces the risk of HIV transmission by 99.9 percent. The treatment involves two injections per year, offering an alternative to daily oral pills. The World Health Organization recommends lenacapavir for preventing HIV infection.
Dr. Reddy's Laboratories and Unitaid announced the authorization. Dr. Reddy's is the Indian pharmaceutical company manufacturing the generic version. Deepak Sapra, the company's chief executive of Pharmaceutical Services, stated that developing this complex long-acting injectable required strong scientific capabilities. He added that the project aimed to meet an urgent need for access at an affordable price.
Gilead originally developed 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 royalty-free and cover approximately 120 countries. The price of $40 was set through a deal involving Dr. Reddy's, Unitaid, Wits RHI, and CHAI.
The availability of the generic drug varies by location. In some countries with existing licenses, distribution could begin within weeks of regulatory approval. In other regions, widespread supply is not expected until 2027. The timeline depends on local regulatory authorities and whether a country is included in Gilead's voluntary licensing agreements.
