Dr. Reddy's Laboratories has secured tentative approval from the United States Food and Drug Administration (FDA) for the first generic version of lenacapavir, a twice-yearly HIV prevention injection. This regulatory milestone could accelerate the availability of a more affordable long-acting HIV prevention option in 120 low- and middle-income countries. Initial supplies are 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).
The development of the generic version follows a pricing agreement announced in September 2025 between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI), and Dr. Reddy's. The agreement combined an early pricing commitment with financial, technical, and regulatory support to accelerate the generic's development and market entry. The partners have been working together to make the injection available to millions more people at a projected price of $40 per year.
Demand for the original product is already emerging in Africa, with more than 125,000 people across 10 early-adopter African countries having started using Gilead's lenacapavir. The generic approval brings the partners closer to making the injection available to millions more people. According to Unitaid Executive Director Dr. Philippe Duneton, the accelerated development demonstrates how early investment and partnerships can shorten the time between scientific breakthroughs and access in lower-income countries.
The injection could change how people access HIV prevention by reducing the need for daily medication. CHAI Chief Executive Officer Dr. Neil Buddy Shah said that 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. The partners cautioned that regulatory approval and affordability alone would not guarantee widespread access.
Countries would need prepared health systems, trained providers, and community involvement to ensure the new prevention option reaches underserved populations. Wits RHI Director of Implementation Science Professor Saiqa Mullick said that an affordable drug alone is not enough. Effective delivery systems would be essential to achieving equitable access. The partners are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy, the Gates Foundation, and other organizations to support introduction, community engagement, and evidence generation.
Dr. Reddy's said that 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 generic development builds on voluntary licenses granted by Gilead in late 2024 to six generic manufacturers, including Dr. Reddy's.
The partners are optimistic about the potential impact of the generic HIV prevention injection. With lenacapavir, they have helped shorten the timeline to just over a year, providing faster access to a groundbreaking HIV prevention option. This could avert countless infections and drive meaningful change in the HIV response, particularly for young women in Africa.
Key points
- Dr. Reddy's Laboratories secures FDA approval for generic HIV prevention injection.
- The generic version is expected to be priced in line with oral pre-exposure prophylaxis (PrEP).
- The partners are working together to make the injection available to millions more people at a projected price of $40 per year.
