On November 2, 2026, the U.S. Food and Drug Administration granted tentative approval to Dr. Reddy's Laboratories for the first generic version of injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP). This is the twice-yearly shot Gilead sells in the U.S. as Yeztugo. Unitaid, which co-funded the work, says it is one of the fastest generic approvals for a major HIV medicine. It came 16 months after the FDA approved Gilead's original product in June 2025. Generics for important HIV drugs have often taken around a decade.

Why It Matters

**PrEP now has two very different prices.** Gilead's lenacapavir business is booming in rich markets. Yeztugo booked **$305 million** in Q3 ([*Twice a Year, Twice the Sales*](/stories/gilead-q3-prep-yeztugo-305m)). Meanwhile the same molecule will cost **$40 a year** across most of the Global South. The licensing structure keeps the two markets apart, but the gap of roughly 700 times will feed U.S. arguments over price, especially after a St. Louis clinic study found about four in ten patients prescribed injectable PrEP never got a shot, mostly because of coverage barriers ([*Wanted It, Couldn't Get It*](/stories/injectable-prep-insurance-barriers-idweek)). **For the sexual-health business**, long-acting prevention keeps moving from clinics to platforms. Grindr just closed its PrEP-provider deal ([*Swipe Right on a Pharmacy*](/stories/grindr-purposemed-freddie-250m)). Latin America has its own lenacapavir supply route through PAHO ([our coverage](/stories/gilead-paho-lenacapavir-latin-america)), and Merck has licensed generics of its once-monthly pill candidate in advance ([*alimatravir*](/stories/merck-alimatravir-african-generic-licences)). The fast-generic model used here, with pricing committed early and donors covering the regulatory filing, could become the template for the next prevention products, including once-yearly lenacapavir data due in 2027. The open risk is delivery: Ghana and Uganda are reporting condom shortages linked to cuts in donor funding, so a $40 product still needs someone to fund clinics to give the shots.

The price is the headline. Under a September 2025 agreement between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy's, the generic will cost US$40 per person per year in the 120 low- and middle-income countries covered by Gilead's voluntary licence. Unitaid says that is "in line with oral PrEP." The first supplies are expected to reach countries before the end of 2026, with wider availability in 2027. STAT reports Dr. Reddy's plans to start shipping next month. Demand is already there: Unitaid and CHAI say more than 125,000 people in 10 African countries have started Gilead's branded lenacapavir. "Getting a generic approved just 16 months after the originator, rather than a decade later, shows what's possible when we prioritize access from the start," said CHAI CEO Dr. Neil Buddy Shah.

It isn't coming to U.S. pharmacies. POZ notes that the generic will not be sold in the United States, where Yeztugo costs about $28,000 a year and the final patents don't expire until 2040. A tentative approval means the FDA has found the product meets its standards but patent and exclusivity protections stop it being marketed in the U.S. It does allow U.S. government procurement for overseas programs and can speed up approvals elsewhere. The clinical case is the same as for Gilead's drug. In PURPOSE 1, no young women assigned to lenacapavir acquired HIV at one year. PURPOSE 2 showed a 96% reduction in HIV acquisition among gay, bisexual and gender-diverse participants. Wits RHI's Prof. Saiqa Mullick warned that "an affordable drug alone is not enough" without health systems ready to deliver it.

Sources

Update — 2026-11-04

Initial entry — story first created.