The Food and Drug Administration has granted tentative approval to Dr. Reddy’s Laboratories for a generic version of lenacapavir, the twice-yearly HIV prevention injection, at a projected cost of $40 per person per year in 120 low- and middle-income countries. For families in those countries, the number is the story: the brand-name version sold in the U.S. as Yeztugo carries a list price of $28,218 a year.
The approval was announced Monday morning by the manufacturer and the global health organizations that helped speed the drug’s development. Zambia is expected to be the first country to receive supplies, with initial shipments anticipated by the end of 2026.
What the Shot Does
Lenacapavir is an injectable preventive medicine given once every six months. In two major studies of people at high risk, it nearly eliminated new infections, and it is widely described as the closest thing the world has to an HIV vaccine. The United Nations believes it could be key to reaching the goal of ending the AIDS epidemic by 2030.
The comparison with daily pills matters more than it might seem. Oral pre-exposure prophylaxis, or PrEP, works only when people take it consistently. “People don’t always take their daily dose of medication, and if you do not take it, you cannot get protected against HIV,” said Carmen Pérez Casas, HIV lead at Unitaid, the global health agency. “With lenacapavir, we are much more hopeful.”
The generic will cost about the same as those daily tablets, so the price alone is not the advance. The advance is that protection no longer depends on a pill every morning. Dr. Neil Buddy Shah, chief executive of the Clinton Health Access Initiative, put the human side plainly: “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. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely.”
Sixteen Months Instead of a Decade
The speed of this approval is unusual enough to be worth pausing on. The generic cleared the FDA about 16 months after the agency approved Gilead Sciences’ original product. Life-saving antiretroviral therapy, by contrast, was available in the West for a full decade before it reached sub-Saharan Africa, a delay that cost countless lives.
“It has never been so fast that the generic product comes so soon after the originator is approved,” Pérez Casas said. “Normally, you require around a decade.”
The partnership behind that timeline was brokered by Unitaid, the Clinton Health Access Initiative and Wits RHI, a health research institute in Africa. A pricing agreement announced in September 2025 combined an early price commitment with financial, technical and regulatory support to move the generic through development and toward market entry. Dr. Reddy’s, based in India, is one of the world’s largest generic drugmakers.
The FDA designation is “tentative,” the agency’s standard label for generics while the original product remains under patent. Generic lenacapavir cannot be sold in the United States for that reason. But FDA approval can speed regulatory review in many other countries, which is why the tentative label still carries weight abroad.
Demand Already Outrunning Supply
Gilead has been the sole supplier of lenacapavir until now, and demand has outstripped supply in low- and middle-income countries. Last year the company established royalty-free licensing agreements with six generic manufacturers, covering a specific set of countries in sub-Saharan Africa, Asia and Latin America. Unitaid selected Dr. Reddy’s from among them to bring an affordable version forward.
The appetite is already visible. More than 125,000 people across 10 early-adopter African countries have started using Gilead’s lenacapavir, according to the partners. “We share the sense of urgency around expanding access to lenacapavir for HIV prevention,” a Gilead spokesperson said in a statement.
The Numbers Behind the Need
According to the World Health Organization, 41 million people worldwide were living with HIV last year, and 570,000 died from HIV-related causes. Around 1.2 million people are infected each year, many of them in low-income countries.
Advocates have a target in mind. “We could help to scale this to the 20 million people around the world who need PrEP,” said Carolyn Amole, who leads the HIV program at the Clinton Health Access Initiative. “And if we scale to those levels, we can actually begin to bring an end to the HIV epidemic.”
That gap between 125,000 current users and 20 million people who need PrEP is where the next chapter of this story sits. The approval arrives at a difficult moment: at the start of 2025 the world was on track to end the AIDS pandemic by 2030, but aid cuts from the U.S., the UK and other European countries have caused the biggest disruption to the HIV response on record, from testing to treatment and prevention.
A Drug Is Not a Delivery System
The partners were careful to say that a low price and a regulatory green light do not by themselves guarantee access. Countries will need prepared health systems, trained providers and community involvement to reach the people who need the injection most.
“An affordable drug alone is not enough,” said Professor Saiqa Mullick, director of implementation science at Wits RHI. Dr. Philippe Duneton, executive director of Unitaid, framed the achievement around the people it is meant to reach: “For young women in Africa, this translates into faster access to a groundbreaking HIV prevention option, with the potential to avert countless infections and drive meaningful change in the HIV response.”
For readers in the U.S., the practical picture is unchanged for now: Yeztugo remains the only version available domestically, at a list price of $28,218 a year before insurance. Anyone weighing HIV prevention options should talk with their doctor about which method fits their health and circumstances.
The first generic supplies are expected to reach countries by the end of 2026, with Zambia at the front of the line.
Sources
- FDA OKs generic HIV prevention shot, widening access for lower-income countries
- Approval of cheap version of HIV-prevention shot raises hopes in low-income countries
- US approves cheap generic version of world’s only twice-yearly HIV prevention jab
- Generic HIV prevention injection moves closer to 120 countries after FDA approval
- Approval of India-made HIV-prevention shot raises hopes in poorer nations
- Cheap lenacapavir HIV-prevention shot approved, raising hopes in poor countries
Photo: EEJCC (CC BY-SA 4.0)
