The FDA has granted tentative approval to the first generic injectable lenacapavir for HIV prevention, made by India’s Dr. Reddy’s Laboratories, the company and its partners announced Monday, Nov. 2. Lenacapavir is the drug Gilead Sciences sells for prevention in the U.S. as Yeztugo, the twice-yearly PrEP shot.
Dr. Reddy’s version will cost $40 per person per year in the 120 low- and middle-income countries covered by Gilead’s license, Unitaid said, a price “in line with oral PrEP.” It cannot be sold in the U.S. Yeztugo is still under patent, and its U.S. list price is $28,218 a year, The Associated Press reported.
“For someone at risk of HIV, taking a pill every day to prevent a disease they don’t have is a hard thing to ask,” said Neil Buddy Shah, CEO of the Clinton Health Access Initiative. “Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely.”
People don’t always take a daily pill, “and if you do not take it, you cannot get protected against HIV,” Carmen Pérez Casas, Unitaid’s HIV lead, told the AP. “With lenacapavir, we are much more hopeful.”
Can You Get Generic Lenacapavir in the U.S.? Not Yet
A tentative approval “does not allow the applicant to market the generic drug product,” the FDA’s glossary says. Final approval waits until “all patent or exclusivity issues have been resolved.” (So no, your pharmacist can’t swap in a $40 version.)
The partners’ release said the designation “enables procurement by the US government.” Washington buys HIV drugs for other countries through PEPFAR, its global AIDS program. “PEPFAR only procures ARVs that have been granted tentative approval or approval” by the FDA’s drug center, the agency’s PEPFAR page says. Those drugs are distributed outside the U.S.
Gilead Puts Yeztugo’s Pharmacy Coverage at ‘About 70% or So’
Gilead officials say that price is similar to some other types of PrEP, the AP reported. The shot made $305 million in the third quarter, and Johanna Mercier, Gilead’s chief commercial and corporate affairs officer, put its pharmacy-benefit coverage at “about 70% or so,” Gayety reported Oct. 30.
When the FDA approved Yeztugo in June 2025, CEO Daniel O’Day said, “This is a historic day in the decades-long fight against HIV.” Gilead said then that its Advancing Access copay program could cut costs to as little as $0 for eligible patients with commercial insurance. Eligible uninsured patients could get the shot free, it said.
At one St. Louis clinic, about 4 in 10 patients prescribed injectable PrEP never got a shot, mostly over insurance, Washington University researchers led by Dr. Aditi Ramakrishnan found. “Interest in LAI PrEP exceeds real-world access,” they wrote, using the shorthand for long-acting injectable.
What PURPOSE 1 and PURPOSE 2 Found About Twice-Yearly PrEP
Dr. Colleen Kelley of Emory University, a principal investigator on PURPOSE 2, said in 2024 that high HIV diagnosis rates in the U.S. South, especially among gay and bisexual men of color and transgender people, demanded new approaches. That trial enrolled cisgender men, trans men, trans women and nonbinary people who have sex with partners assigned male at birth, in seven countries including the U.S., Gilead said.
In the trials’ primary analyses, two of the 2,179 people receiving lenacapavir in PURPOSE 2 acquired HIV. PURPOSE 1, which enrolled cisgender adolescent girls and young women in South Africa and Uganda, recorded no infections among the 2,134 participants receiving it. The CDC’s review puts the reductions in HIV incidence at 96% and 100%, respectively, compared with each trial’s estimated background rate without PrEP. Both trials also found fewer infections than with daily Truvada.
Yeztugo’s FDA-approved label requires HIV testing before starting and before each subsequent injection. It warns that using the drug during an undiagnosed infection can lead to HIV that resists lenacapavir. The regimen begins with injections and oral tablets, followed by injections every six months. HIV.gov has a plain-English rundown of PrEP options.
Dr. Reddy’s $40 PrEP Shot: First Supplies Expected This Year
Gilead handed out royalty-free licenses for lenacapavir to six generic makers, Dr. Reddy’s among them, in October 2024. Unitaid, CHAI and Wits RHI, a South African research institute, later backed Dr. Reddy’s with money and regulatory help.
“This is a moment of immense pride for all of us at Dr. Reddy’s,” said Deepak Sapra, the company’s CEO for API and services.
“With best-in-class HIV treatment, we delivered in four years what used to take ten,” said Dr. Philippe Duneton, Unitaid’s executive director. “Now, with lenacapavir, we have helped shorten that timeline to just over a year.”
Unitaid expects the first generic doses to reach countries before the end of 2026, with wider rollout in 2027. More than 125,000 people in 10 African countries have already started Gilead’s own lenacapavir, it said.
Carolyn Amole, who runs CHAI’s HIV program, told the AP that buying the shot for everyone who needs it will take more funding. “The work is not done,” she said. “But this is a great milestone.”
“We believe we have enabled the fastest and most sustainable path to expanding access for communities most affected by HIV,” a Gilead spokesperson said in a statement, according to the AP. No other company’s generic lenacapavir has FDA approval yet, the AP reported.
