Dr. Reddy’s Laboratories wins tentative approval for generic lenacapavir 16 months after the original drug was approved, with initial supplies expected in low- and middle-income countries by end-2026.
By Bunmi Yekini
Indian drugmaker Dr. Reddy’s Laboratories has secured tentative approval from the U.S. Food and Drug Administration for the first generic version of a long-acting HIV prevention injection, potentially bringing a cheaper alternative closer to millions of people at risk of infection.
The approval for injectable lenacapavir comes 16 months after the FDA approved Gilead Sciences’ original product for HIV prevention, according to global health organisation Unitaid, which said initial supplies of the generic were expected to reach low- and middle-income countries by the end of 2026.
The twice-yearly injection offers an alternative to daily HIV prevention pills, with generic treatment expected to cost about $40 per person annually, in line with oral pre-exposure prophylaxis, or PrEP. The development could significantly expand access to HIV prevention, particularly among young women and other vulnerable populations in countries with high infection rates.
More than 125,000 people in 10 African countries have already started using Gilead’s lenacapavir before generic versions become available, Unitaid said.
“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” said its executive director, Philippe Duneton.
For young women in Africa, faster access to the injection could help prevent infections and strengthen efforts to curb the epidemic, he said. Lenacapavir has demonstrated nearly 100% effectiveness in preventing HIV in clinical trials, according to the release.
Neil Buddy Shah, chief executive of the Clinton Health Access Initiative (CHAI), said the injection could overcome some of the challenges associated with daily prevention medication.
“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,” Shah said. “Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely.”
He said the generic approval, secured just 16 months after the original product, showed what could be achieved when access was prioritised early in drug development.
The approval follows a pricing agreement announced in September 2025 involving Unitaid, CHAI, the Wits Reproductive Health and HIV Institute (Wits RHI) and Dr. Reddy’s.
The partnership provided financial, technical and regulatory support to accelerate the development and market entry of the generic drug.
The FDA approval was facilitated by a regulatory strategy that combined lenacapavir’s HIV prevention and treatment indications in a single application, allowing the company to seek priority review, Unitaid said.
Gilead granted voluntary licences to six generic manufacturers in late 2024, including Dr. Reddy’s, helping pave the way for more affordable versions.
But health experts say regulatory approval alone will not guarantee access.
“Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough,” said Saiqa Mullick, director of implementation science at Wits RHI.
Countries will need prepared health systems, trained healthcare providers and community engagement to ensure the injection reaches people who need it, she said.
Unitaid, Wits RHI and CHAI are working with governments, communities, the Global Fund, the U.S. Bureau of Global Health Security and Diplomacy, the Gates Foundation and other partners to support country introductions and generate evidence on how best to deliver the drug.
The FDA’s tentative approval allows the generic product to move towards regulatory approvals in other countries and supports procurement by the U.S. government while the original drug remains under patent. Unitaid said the approval was an important step towards expanding access but cautioned that further work would be needed to ensure the drug reaches underserved populations. The organisation, a partnership hosted by the World Health Organization, works to make new health products affordable and accessible in low- and middle-income countries.