Sixteen months after lenacapavir, the twice-yearly injection described as the closest thing yet to an HIV vaccine, was first approved, the US Food and Drug Administration has cleared a generic version made by Dr. Reddy’s Laboratories. The tentative approval allows the drug to be bought through America’s global HIV programme. It brings a price of about US$40 per person per year within reach of 120 low- and middle-income countries. The branded product’s US list price is more than $28,000.
For four decades, preventing HIV has depended on people doing something over and over: using a condom every time, or taking a pill every day. Lenacapavir changes that arithmetic. One injection under the skin protects for six months. On Monday, a Hyderabad drugmaker took a decisive step towards making it affordable to the people who need it most.
The US Food and Drug Administration (FDA) has granted tentative approval to Dr. Reddy’s Laboratories for a generic version of injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP). It is the first generic version of the drug to be approved by the FDA, according to Unitaid, the global health agency that helped to fund its development. The approval came under the US President’s Emergency Plan for AIDS Relief (PEPFAR).
What “tentative approval” means
The FDA uses a tentative approval when a generic medicine meets its standards for safety, efficacy and manufacturing quality, but cannot yet be sold in the United States because the originator’s patents or exclusivities are still in force. Gilead Sciences, which developed lenacapavir, markets it in the US as Yeztugo.
For PEPFAR, a tentative approval is sufficient. It allows the US government’s HIV programme to buy the product for use abroad. Just as importantly, many national regulators and procurement agencies treat an FDA quality assessment as a strong signal. The generic will still need WHO prequalification and approval in each country before it reaches clinics.
Dr. Reddy’s filed a single application covering both prevention and treatment uses. The FDA granted it priority review, according to the Clinton Health Access Initiative (CHAI). Dr. Reddy’s has not named the manufacturing site in the material NSH reviewed, and NSH did not see the company’s stock-exchange filing.
Why lenacapavir matters
Lenacapavir is the first of a new class of drugs called capsid inhibitors. They target the protein shell that encloses the virus’s genetic material, and so interfere with several stages of its life cycle. The drug is so potent, and is released so slowly from the injection site, that one dose lasts about six months.
Two large trials established its preventive value:
- PURPOSE 1 enrolled cisgender women in South Africa and Uganda. It recorded no HIV infections among those receiving lenacapavir (New England Journal of Medicine, 2024).
- PURPOSE 2 enrolled a diverse group of men and gender-diverse people. It recorded two infections among 2,179 participants, a 96% reduction against the background incidence, and the injection outperformed daily oral PrEP.
The reason the results drew such attention is adherence. Oral PrEP works very well when taken consistently, but many people stop or miss doses, because of stigma, travel, or simply the burden of a daily pill. A clinic visit twice a year removes most of that difficulty.
“Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” said Dr Neil Buddy Shah, chief executive of CHAI.
From breakthrough to access in record time
The speed is part of the story. In October 2024 Gilead signed royalty-free voluntary licences with six generic manufacturers to make lenacapavir for 120 high-incidence, resource-limited countries. Dr. Reddy’s was one of them, as was Hetero, also of Hyderabad. Gilead’s own product received FDA approval in June 2025. In September 2025 Unitaid, CHAI, the Wits Reproductive Health and HIV Institute (Wits RHI) and partners announced an agreement to bring the generic price to about $40 per person per year. CHAI says that is in line with the cost of oral PrEP.
According to Unitaid, the gap between the originator’s approval and the first generic approval has shrunk to just over a year. For earlier HIV medicines it was several years. Dr Philippe Duneton, Unitaid’s executive director, said the agency’s “early risk-taking is helping shorten the time between a scientific breakthrough and real access”.
Deepak Sapra, chief executive of API and Services at Dr. Reddy’s, called the approval “a moment of immense pride for all of us at Dr. Reddy’s” and said it “validates that work”.
First supplies are expected by the end of 2026, with wider availability in 2027, according to Unitaid. Gilead’s branded product is already in use: more than 125,000 people in ten early-adopter African countries have started it.
The Indian dimension
India has long been described as the “pharmacy of the developing world”, and HIV medicines are where that reputation was built. In the early 2000s, Indian generic antiretrovirals cut the cost of HIV treatment from thousands of dollars a year to well under a hundred, making mass treatment in Africa possible. The lenacapavir approval extends that tradition from treatment to long-acting prevention. Long-acting injectables are technically more demanding to manufacture, because the drug’s slow, controlled release depends on tightly controlled formulation and quality.
For Hyderabad, it reinforces the city’s position as a centre of complex generics and active-ingredient manufacturing. It also strengthens the commercial case for investing in long-acting formulations, an area where Indian firms have historically trailed their Western peers.
The approval does not, by itself, change prevention in India. India is not among the countries where Gilead’s branded product is registered, and lenacapavir is not part of India’s national HIV programme. Whether Indian regulators and the National AIDS Control Organisation consider it, and at what price, is a separate question that the approval makes more pressing.
The caveats
An affordable product is necessary but not sufficient. “An affordable drug alone is not enough,” said Professor Saiqa Mullick of Wits RHI. “Countries need health systems that are ready to deliver new prevention options.” People need an HIV test before starting and at each injection, which demands reliable testing and record-keeping. Common side-effects include injection-site reactions, headache and nausea.
Funding is the other uncertainty. Global HIV programmes have faced cuts since 2025, and a $40 price still has to be paid by someone. Advocates estimate that about 20 million people could benefit from PrEP. Reaching even a fraction of them will depend on donors, national budgets and the Global Fund.
– Rashmi Kumari
