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.
“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.
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.
Notes to the editor
About U.S. FDA tentative approval:
Tentative approval is the FDA’s standard designation for generics while the originator remains under patent, and it enables procurement by the US government.
About the novel regulatory strategy:
Lenacapavir has two indications, HIV prevention and HIV treatment. Dr. Reddy’s combined both in a single application, which allowed it to file through the FDA’s 505(b)(2) pathway. The FDA granted a priority review, which targets a decision within six months. This was one of several steps that compressed the overall timeline, alongside Gilead’s early voluntary licensing and financial, technical, and regulatory support from Unitaid, Wits RHI, and CHAI.
About Unitaid
Unitaid saves lives by making new health products affordable and available in low- and middle-income countries. Collaborating with partners, Unitaid identifies innovative treatments, tackles market barriers, and quickly delivers solutions to those in need. Since 2006, Unitaid has unlocked over 100 health products, addressing HIV, TB, malaria, women’s and children’s health, and pandemic preparedness. Every year, these products benefit more than 300 million people. Unitaid is a hosted partnership of the World Health Organization. www.unitaid.org
About Wits RHI
Wits RHI, is a research institute of the University of the Witwatersrand, established in 1994 by Professor Helen Rees to support South Africa’s newly democratic government in shaping national health policies, has grown into a leading African research and implementation institute with a global reputation for innovation and responsiveness to health challenges. With a 30-year track record in investigator-led and consortia studies, Wits RHI excels in policy development and implementation across diverse populations and all phases of clinical trials. Its multidisciplinary approach integrates research, technical assistance, advocacy, and health systems strengthening to deliver impactful solutions in infectious and vaccine-preventable diseases, maternal and family health, antimicrobial resistance, and climate-related health crises. The Institute applies rigorous epidemiological and qualitative methods to identify health problems, generate evidence, and evaluate interventions in real-world settings. Its work spans vaccines, therapeutics, diagnostics, and modelling, with a focus on HIV, TB, STIs, COVID-19, influenza, Mpox, Rotavirus, and outbreak pathogens including Poxviruses, Ebola, and Yellow Fever. www.wrhi.ac.za
About CHAI
The Clinton Health Access Initiative, Inc. (CHAI) is a global health organization committed to saving lives and improving health outcomes in low- and middle-income countries by enabling the government and private sector to strengthen and sustain quality health systems. For more information, please visit: www.clintonhealthaccess.org
About Dr. Reddy’s Laboratories
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com