U.S. FDA Approves First Generic Injectable Lenacapavir for HIV Prevention

The U.S. Food and Drug Administration (FDA) has approved the first generic long-acting injectable for HIV prevention, just 16 months after the approval of the originator product. A novel regulatory strategy resulted in one of the fastest timelines to approval for a major HIV innovation to date.

Developed by Dr. Reddy's Laboratories with financial, technical, and regulatory support from Unitaid, Wits RHI, and the Clinton Health Access Initiative (CHAI) to accelerate the product's development and regulatory filing and speed up lenacapavir's market entry.

Under the existing partnership agreement, Dr. Reddy's lenacapavir injection will be available at US$40 per person per year for the 120 low- and middle-income countries included in Gilead's voluntary license.

First supplies of the generic are expected to reach countries before the end of the year, with broader availability in 2027.

Geneva, 2 November 2026 - Dr. Reddy's Laboratories has secured FDA tentative approval for the first generic injectable lenacapavir, just 16 months after a Gilead's originator product was approved for HIV prevention. The milestone brings an affordable version of the highly effective, twice-yearly HIV prevention injection closer to people in 120 low-and middle-income countries, with initial supplies expected to reach countries by end of 2026.

This approval follows a landmark pricing agreement announced in September 2025 between Unitaid, Wits RHI, CHAI, and Dr. Reddy's. The agreement combined an early pricing commitment with financial, technical and regulatory support to accelerate development and market entry of Dr. Reddy's generic lenacapavir.

For people at risk of HIV infection, this means a long-acting injectable prevention option that doesn't require a daily pill, at a price in line with oral PrEP, a key condition for uptake in low- and middle-income countries. Demand is strong. Even before generic availability, over 125,000 people in 10 early adopter African countries have already started Gilead's lenacapavir.

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"Unitaid's early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries," said Dr. Philippe Duneton, Executive Director at Unitaid. "With best-in-class HIV treatment, we delivered in four years what used to take ten. Now, 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."

"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," said Dr. Neil Buddy Shah, CEO of CHAI. "More than 125,000 people in Africa have already started on lenacapavir, and today's approval brings us closer to making it available to millions more for just $40 a year. Getting a generic approved just 16 months after the originator, rather than a decade later, shows what's possible when we prioritize access from the start. This should be the new standard for global health."

"Generic lenacapavir has the potential to transform HIV prevention, and this is a significant milestone, but an affordable drug alone is not enough." said Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand. "Countries need health systems that are ready to deliver new prevention options, providers who are confident in offering them, and communities that are engaged as partners in their introduction and scale-up. Bringing these elements together will be critical to ensuring equitable access and impact."

"This is a moment of immense pride for all of us at Dr. Reddy's. Developing and manufacturing a complex, long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities, manufacturing expertise and the ability to produce at scale. The U.S. FDA approval validates that work and brings us a significant step closer to making this twice-yearly HIV prevention option available to people across low- and middle-income countries. We are grateful to Gilead for the voluntary license and to Unitaid, Wits RHI and CHAI for their support in accelerating this journey," said Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's Laboratories Ltd.

From originator approval to generic in 16 months

In June 2025, the FDA approved Gilead's originator product for HIV prevention. Dr. Reddy's received tentative FDA approval for a generic version just 16 months later. This builds on work that began in late 2024 when Gilead granted voluntary licenses for lenacapavir to six generic manufacturers, including Dr. Reddy's.

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This rapid progress was made possible by a partnership between Unitaid, Wits RHI, and CHAI with Dr. Reddy's to provide financial, technical, and regulatory support to help the company bring a quality-assured generic to market. Through a novel regulatory approach, partners combined lenacapavir's prevention and treatment indications in a single application, allowing Dr. Reddy's to request and secure a priority review from the FDA. Alongside other targeted interventions, this helped shorten a process that would typically take many years.

Approval is a milestone, not the finish line

Today's tentative approval provides a critical regulatory foundation that can accelerate the remaining steps, support national regulatory approvals, and allow countries to move faster towards introduction.

Unitaid, Wits RHI, and CHAI are working with governments, communities, the Global Fund, the U.S. Bureau of Global Health Security and Diplomacy (GHSD), the Gates Foundation, and other partners to turn approval into access on the ground, from supporting country introduction and community engagement to generating real-world evidence to inform how lenacapavir can best reach diverse and underserved populations.