FDA grants tentative approval to Dr. Reddy’s generic HIV prevention shot

The Food and Drug Administration granted tentative approval on Monday to Dr. Reddy’s Laboratories for a generic version of lenacapavir, the twice-yearly injectable HIV pre-exposure prophylaxis that Gilead Sciences sells as Yetzugo in the United States, according to STAT and Medical Xpress.

STAT reported that Dr. Reddy’s, a major global generic manufacturer, intends to begin exporting the medicine next month. Each person's yearly supply will cost $40, similar to daily oral PrEP. Medical Xpress reported that this $40 annual price will apply in 120 nations under a September 2025 pricing deal involving Unitaid, Wits RHI, the Clinton Health Access Initiative, and Dr. Reddy’s.

Lenacapavir is given once every six months. Gilead’s version was approved in June 2025 after large clinical trials showed it was more than 99.9% effective at preventing HIV, according to Medical Xpress. The journal Science named lenacapavir “Breakthrough of the Year” in 2024.

Daily oral PrEP pills first won U.S. approval in 2012, and cabotegravir, an injectable PrEP requiring shots every two months, was approved in 2021, Medical Xpress reported. Because daily pills only work if taken consistently, a twice-yearly injection can be a more effective way to deliver PrEP.

Unitaid, a global health initiative, announced the approval with Dr. Reddy’s. Carmen Perez-Casas, who leads strategy for HIV and pandemic preparedness at Unitaid, called the decision “an extraordinary milestone for global health.” She noted that people in poorer nations typically wait a decade or longer for new therapies, but with lenacapavir “we’ve reduced that gap to little more than a year.”

Unitaid said the FDA based the tentative approval on an accelerated route that lets sponsors rely on previously submitted data. Medical Xpress reported that in the U.S., the brand-name medicine is priced at about $28,000 annually, though patients often pay less with insurance. Toward the end of 2024, Gilead issued voluntary licenses to six generic companies, among them Dr. Reddy’s. Unitaid said that prior to the generic launch, over 125,000 individuals in ten African nations that were early adopters had already begun using Gilead's product.

Dr. Reddy’s CEO of Pharmaceutical Services and API, Deepak Sapra, said in a statement that the approval was “a moment of immense pride for all of us at Dr. Reddy’s.” Perez-Casas said the real work ahead is rollout. “An estimated 1.2 million people acquired HIV last year, even as we now have a medicine offering near-100% protection with just two injections a year,” she said. Unitaid said it is collaborating with governments and other groups to help countries lead their own introduction of the drug.