The US Food and Drug Administration (FDA) gave its seal of approval to a generic version of injectable lenacapavir, the drug that can protect from HIV infection for six months, with the Indian manufacturer, Dr. Reddy’s Laboratories, promising to sell the drug for only $40 per person per year.
Lenacapavir, which was developed by Gilead Sciences, received FDA approval in June 2025 as a “pre-exposure prophylaxis” (PrEP) to uninfected people. But in the US, two doses—a year cost about $28,000.
Gilead provides lenacapavir at a “not-for-profit” price to the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
But it also licensed lenacapavir to six generic manufacturers, stipulating they could only sell it to 120 low- and lower middle–income countries. Dr. Reddy’s, based in Hyderabad, India, is the first to get FDA approval for its product.
