Nairobi — Access to a twice-yearly HIV prevention injection is moving closer to millions of people in low- and middle-income countries after Dr. Reddy’s Laboratories secured tentative approval from the United States Food and Drug Administration (FDA) for the first generic version of lenacapavir.
The regulatory milestone, secured just 16 months after approval of Gilead Sciences’ original product, could accelerate the availability of a more affordable long-acting HIV prevention option in 120 low- and middle-income countries, with initial supplies expected to reach countries by the end of 2026.
The generic version is expected to be priced in line with oral pre-exposure prophylaxis (PrEP), potentially making the twice-yearly injection more accessible to people at risk of HIV who may find taking daily preventive pills challenging.
The development follows a pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s, combining an early pricing commitment with financial, technical and regulatory support to accelerate the generic’s development and market entry.
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Demand for the original product is already emerging in Africa. More than 125,000 people across 10 early-adopter African countries have started using Gilead’s lenacapavir, according to the partners.
Unitaid Executive Director Dr. Philippe Duneton said the accelerated development demonstrated how early investment and partnerships could shorten the time between scientific breakthroughs and access in lower-income countries.
“With lenacapavir, we have helped shorten that timeline to just over a year. 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,” Duneton said.
CHAI Chief Executive Officer Dr. Neil Buddy Shah said the injection could change how people access HIV prevention by reducing the need for daily 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. Two injections a year, of a product that is almost 100% effective at preventing HIV, changes that entirely,” Shah said.
He said the generic approval brings the partners closer to making the injection available to millions more people at a projected price of $40 per year.
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However, the partners cautioned that regulatory approval and affordability alone would not guarantee widespread access.
Wits RHI Director of Implementation Science Professor Saiqa Mullick said countries would need prepared health systems, trained providers and community involvement to ensure the new prevention option reaches underserved populations.
“An affordable drug alone is not enough,” Mullick said, adding that effective delivery systems would be essential to achieving equitable access.
Dr. Reddy’s said developing and manufacturing the long-acting injectable at an affordable price required significant scientific and manufacturing capabilities.
The FDA’s tentative approval provides a regulatory foundation for the remaining steps, including national regulatory approvals and country-level introduction.
The partners are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy, the Gates Foundation and other organisations to support introduction, community engagement and evidence generation.
The generic development builds on voluntary licences granted by Gilead in late 2024 to six generic manufacturers, including Dr. Reddy’s.
The company combined lenacapavir’s HIV prevention and treatment indications in a single application through the FDA’s 505(b)(2) regulatory pathway, securing priority review and helping shorten the approval timeline.