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Unitaid and Gates Strike Deals to Deliver $40‑a‑Year Lenacapavir PrEP Generics From 2027

Early branded doses are slated through a Global FundGilead program that targets an initial African delivery by the end of 2025.

Overview

  • Unitaid, CHAI and Wits RHI signed an agreement with Dr Reddy's to supply generic lenacapavir to 120 low‑ and middle‑income countries starting in 2027.
  • The Gates Foundation announced a separate manufacturing partnership with Hetero to produce generics for distribution in eligible countries.
  • The agreed price is $40 per patient‑year, with initial production based in India and plans to regionalize manufacturing over time.
  • These arrangements build on Gilead's October 2024 voluntary licences to six generic makers and on recent U.S. and EU regulatory clearances.
  • Lenacapavir is a twice‑yearly injectable PrEP; the branded U.S. product costs about $28,000 per year, while an interim Global FundGilead pathway aims first shipments to at least one African country by late 2025.