The U.S. Food and Drug Administration has approved the first generic version of lenacapavir, the twice-yearly HIV prevention injection, in a decision that could bring the cost of a highly effective prevention drug down from more than $28,000 a year to about $40 a year in 120 low- and middle-income countries.
The approval, announced on Monday, November 3, 2026, covers a generic version of the drug sold under the brand name Yeztugo by Gilead Sciences. The generic, made by Dr Reddy’s Laboratories, is the first generic lenacapavir to receive FDA approval and is expected to be distributed through global health programmes that supply HIV prevention drugs to countries where the branded version is unaffordable.
Lenacapavir is a long-acting injectable drug given twice a year that has been shown in clinical trials to be almost 100% effective at preventing HIV infection. The branded version, approved in the United States in 2025, costs $28,218 per person per year, a price that has put it out of reach for most people in the countries where HIV is most prevalent.
What the FDA generic lenacapavir approval means for HIV prevention
The generic approval is significant because lenacapavir is one of the most effective HIV prevention tools ever developed. Unlike daily oral PrEP, which requires taking a pill every day, lenacapavir is injected twice a year, removing the adherence problems that limit the effectiveness of daily pills.
In clinical trials, lenacapavir prevented HIV infection in almost all participants, with efficacy rates above 99% in some studies. That level of protection, combined with twice-yearly dosing, makes it particularly suitable for people who struggle to take daily medication or who face stigma around HIV prevention.
The FDA approval does not mean the generic will be sold in the United States at the $40 price — that price is for distribution in low- and middle-income countries through licensing agreements and global health programmes. In the US, the branded version remains the approved product, and its price remains $28,218 per year.
The $40 price tag — and why it is not a US price
The $40 per year figure comes from the cost of manufacturing and distributing the generic in large volumes for global health programmes. Gilead has licensed generic manufacturers to produce lenacapavir for 120 countries, mainly in sub-Saharan Africa, Asia and Latin America, where HIV rates are highest and health budgets are lowest.
That licensing model is similar to the one used for other HIV drugs, where generic versions are sold cheaply in low-income countries while branded versions remain expensive in high-income markets. Critics have argued that the model still leaves many middle-income countries paying high prices, but supporters say it is the fastest way to expand access.
The $40 price is an estimate based on the cost of the generic drug itself, not the full cost of delivery, which includes clinic visits, testing and staff time. Even with those additional costs, health experts say the generic could still be delivered for a fraction of the branded price.
How twice-yearly lenacapavir works and why it matters
Lenacapavir is a capsid inhibitor, a type of drug that blocks HIV from replicating by interfering with the virus’s protein shell. It is given as an injection under the skin, with two injections per year providing continuous protection.
The drug’s long-acting nature is its key advantage over daily pills. Studies have shown that many people who start daily PrEP stop taking it within a year, often because of the burden of daily dosing, side effects or stigma. A twice-yearly injection removes those barriers, making it easier for people to stay protected.
Lenacapavir is also effective for people who cannot take other HIV prevention drugs, including those with kidney problems or other conditions that limit the use of daily pills. The drug has been well tolerated in trials, with injection-site reactions being the most common side effect.
Dr Reddy’s generic and the 120 countries covered
Dr Reddy’s Laboratories, an Indian pharmaceutical company, is the first generic manufacturer to receive FDA approval for lenacapavir. The approval is for a generic version that will be supplied to 120 countries under Gilead’s voluntary licensing agreement, which allows generic manufacturers to produce the drug for low- and middle-income markets.
The 120 countries include most of sub-Saharan Africa, where HIV prevalence is highest, as well as countries in Asia, Latin America and the Caribbean. The agreement does not cover high-income countries, where Gilead retains exclusive rights to the branded version.
Other generic manufacturers are expected to seek approval in the coming months, which could further drive down prices and expand supply. The FDA approval for Dr Reddy’s is a first step, but the scale of distribution will depend on manufacturing capacity and funding from global health donors.
What global health experts say about the approval
Global health experts have welcomed the approval as a major step towards expanding HIV prevention, but have warned that approval alone is not enough. The drug must be delivered to clinics, health workers must be trained to administer it, and communities must be informed about its availability.
Winnie Byanyima, executive director of UNAIDS, has previously said that lenacapavir could be a game-changer for HIV prevention if it is made available at an affordable price. The generic approval brings that goal closer, but experts say funding and delivery systems must keep pace.
The approval also comes at a time when global HIV funding is under pressure, with some donors cutting back on aid. Health experts say the low cost of the generic could help stretch limited budgets further, allowing more people to access prevention.
What happens next for generic lenacapavir rollout
The next step is for Dr Reddy’s to begin manufacturing and distributing the generic to the 120 countries covered by the licensing agreement. That process will involve working with global health programmes, including the Global Fund and PEPFAR, to ensure the drug reaches clinics and communities.
That last point — delivery — deserves emphasis: approvals do not by themselves put injections into arms. A related regulatory debate concerns access to compounded medicines, which we covered in our report on Kennedy lets pharmacies compound six unapproved peptides as FDA scientists warn of risks. Lenacapavir’s rollout will depend on supply chains, clinic capacity and public health messaging, all of which take time to build.
For now, the FDA approval is a milestone in the effort to make HIV prevention affordable and accessible. If the generic is rolled out successfully, it could help prevent hundreds of thousands of new HIV infections in the coming years, particularly in sub-Saharan Africa where the burden is greatest.
Sources
USN reviewed reporting from multiple outlets for this story. Read more from the FDA, Gilead Sciences and UNAIDS.