Indian pharmaceutical companies Dr. Reddy’s Laboratories and Hetero Labs announced on September 24, 2025, that they plan to produce and sell generic versions of lenacapavir an injectable HIV prevention drug for approximately USD 40 per year in 120 low- and middle-income countries beginning in 2027. 2
Lenacapavir, branded as Yeztugo by Gilead Sciences, is a twice-yearly injection shown in clinical trials to be nearly 100% effective in preventing HIV when used as pre-exposure prophylaxis (PrEP). The annual cost of the branded version in the U.S. is about USD 28,000, making the proposed generic price a dramatic reduction.
The announcement could expand access to a highly effective prevention option in regions where daily oral PrEP is challenging to maintain due to stigma, adherence issues, or resource constraints. The injection regimen, given once every six months offers an alternative to daily pills for people at higher risk of HIV infection.
Several global health bodies, including Unitaid, the Clinton Health Access Initiative (CHAI), and Wits Reproductive Health and HIV Institute (Wits RHI), are supporting the efforts to scale affordable generics. 3 The Gates Foundation also has a partnership with Hetero to facilitate production and distribution. 1
Under a voluntary license arrangement, Gilead granted six manufacturers royalty-free rights to produce generic lenacapavir for 120 designated countries. Dr. Reddy’s and Hetero are among those six. Gilead’s public statement notes that technology transfer to these licensees is underway to enable generic manufacturing as quickly as possible. 2
Gilead has also committed to providing branded lenacapavir at no profit for certain countries through donation or access programs until generics can meet demand.
Lenacapavir is an antiretroviral drug that inhibits HIV-1’s capsid protein, interfering with multiple stages of the viral life cycle.
The U.S. Food and Drug Administration approved lenacapavir as Yeztugo for HIV prevention in June 2025. Clinical trials reported very high efficacy in preventing HIV transmission.2
Because it is given twice per year, lenacapavir may improve adherence compared to daily oral PrEP, especially in settings where pill fatigue, stigma, or access barriers hamper daily drug use.
Generics producers will need to replicate the formulation reliably and meet regulatory quality standards. The technology transfer process from Gilead includes assistance with manufacturing and regulatory know-how. 2
Affordable access to a long-acting PrEP option could help reduce new HIV infections, particularly in countries with high incidence and difficulty implementing daily PrEP programs.
It could alleviate the adherence burden that many individuals face with daily oral regimens.
The scale of impact will depend on health systems’ ability to integrate this tool, monitor usage, and ensure equitable access.
Activists and advocates emphasize that this announcement is a step forward, but the real test lies in delivery, coverage, and inclusion of all affected populations.
The Gates Foundation. “Expanding Access to HIV Prevention Tool for Millions.” Gates Foundation Press Release, September 24, 2025. https://www.gatesfoundation.org/ideas/media-center/press-releases/2025/09/hiv-prevention-lenacapavir. Gates Foundation
Gilead Sciences. “Gilead Sciences Update on Access Strategy for Lenacapavir for HIV Prevention in High Incidence Resource-Limited Countries.” Gilead Company Statement, 2025. https://www.gilead.com/company/company-statements/2025/gilead-sciences-update-on-access-strategy-for-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries. Gilead
Clinton Health Access Initiative. “Unitaid, CHAI, and Wits RHI Enter into a Landmark Agreement for Lenacapavir Access.” CHAI News, 2025. https://www.clintonhealthaccess.org/news/unitaid-chai-wits-rhi-dr-reddys-lenacapavir-agreement/.
(Rh/Eth/TL/MSM)