Indian pharmaceutical companies Dr. Reddy’s Laboratories and Hetero Labs (Hetero) have signed landmark agreements to manufacture generic versions of lenacapavir, a revolutionary long-acting HIV prevention drug, which will be available at roughly USD 40 per patient per year in low- and middle-income countries (LMICs) starting in 2027.  

Dr. Reddy’s has partnered with Unitaid, the Clinton Health Access Initiative (CHAI), and the Wits Reproductive Health and HIV Institute (Wits RHI) to bring the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP) to LMICs, backed by financial, technical, and regulatory support.

In parallel, the Gates Foundation has signed a separate deal with Hetero to create a pathway for the sustainable and affordable supply of lenacapavir, supported by upfront funding and volume guarantees.

Originally developed by Gilead Sciences, lenacapavir is a twice-yearly injection that has shown exceptional efficacy in preventing HIV. While coordinated global efforts have reduced new HIV infections by 40 percent since 2010, UNAIDS reported 1.3 million new cases in 2024. Experts believe lenacapavir could be transformative for millions of people who struggle with daily oral pre-exposure prophylaxis (PrEP). Notably, these agreements have brought the price of the injectable on par with oral PrEP, a key condition for uptake in low- and middle-income countries.  

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved the drug in record time, and in July 2024, the World Health Organisation (WHO) issued a global recommendation for its use.

 “Just as we did with dolutegravir, which became the most widely used HIV treatment worldwide, we are working with partners to ensure lenacapavir will be within reach for millions who need it most,” said Unitaid’s Executive Director Dr. Philippe Duneton.

President Bill Clinton, Board Chair and Co-Founder of CHAI, called the collaboration a “remarkable breakthrough and a fundamental shift in what’s possible for HIV prevention,” adding that it offers the world a genuine chance to end the epidemic.

Deepak Sapra, Chief Executive Officer of API and Services at Dr. Reddy’s Laboratories, described the partnership as “a significant step in our mission to enhance global patient access and affordability to innovative treatment in the fight against HIV.”

“The development and planned supply of a high-quality, affordable generic version of lenacapavir represents a crucial advancement in the prevention of HIV,” he added.

Professor Saiqa Mullick, Director of Implementation Science at Wits RHI, University of the Witwatersrand, stressed the importance of generics to ensure this breakthrough HIV prevention option is not limited to a privileged few.

“By driving prices down and securing sustainable supply, generics will make six-monthly PrEP a real choice for the millions of people in great need in low- and middle-income countries,” she added.

Hetero’s Managing Director, Dr. Vamsi Krishna, echoed this sentiment, “This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”

These new collaborations build on existing agreements involving the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gilead Sciences; the US State Department through PEPFAR; and the Children’s Investment Fund Foundation (CIFF), to roll out the initial supply of lenacapavir in LMICs, potentially reaching countries as early as the end of 2025.

In 2024, Gilead Sciences granted royalty-free licenses to six generic manufacturers to manufacture and supply generic lenacapavir, subject to required regulatory approvals, in 120 low- and middle-income countries. These include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Mylan, a subsidiary of Viatris.

Following regulatory approvals, generic lenacapavir will flow through national HIV programmes and public procurement channels such as the Global Fund.