FDA tentatively clears Dr. Reddy's twice-yearly generic HIV-prevention injection lenacapavir for low- and middle-income countries

Key facts

• The US Food and Drug Administration (FDA) has granted tentative approval to India-based Dr. Reddy's Laboratories' generic version of lenacapavir, the world's only twice-a-year injectable shot to prevent HIV, under the PEPFAR program.
• The generic is expected to cost USD 40 per person per year across 120 low- and middle-income countries covered by the royalty-free voluntary licenses Gilead Sciences granted to six generic manufacturers, including Dr. Reddy's, in 2024.
• Dr. Reddy's plans to begin first supplies from next month, with broader availability across eligible countries in 2027.
• The generic cannot be sold in the US because Gilead's brand-name version Yeztugo, approved last year, remains under patent, with a US list price of USD 28,218 a year.
• In India, the subject expert committee has favourably recommended the drug's approval, but final marketing approval from the Central Licensing Authority (CDSCO) is still pending.