Hyderabad-based drugmakers Dr. Reddy’s Laboratories and Hetero Labs have signed separate agreements that will make their generic versions of Gilead Sciences’ breakthrough HIV prevention drug lenacapavir available at an affordable price of $40 per patient per year across 120 low- and middle-income countries starting in 2027.
Dr. Reddy’s Partnership with Global Health Agencies
Under a new partnership with Unitaid, the Clinton Health Access Initiative (CHAI), and research institute Wits RHI, Dr. Reddy’s will supply injectable lenacapavir at $40 per year. The agreement includes financial, technical, and regulatory support, ensuring the delivery of affordable, quality-assured generics just under two years after Gilead’s product received approval in high-income countries.
Hetero Labs and Gates Foundation Collaboration
Separately, the Bill & Melinda Gates Foundation and Hetero Labs announced a similar agreement. Backed by upfront funding and volume guarantees, Hetero will manufacture generic lenacapavir at the same $40 annual price after a short pre-treatment oral regimen. According to the Foundation, this price point is designed to make the drug affordable for national health systems and accelerate adoption.
A Breakthrough in HIV Prevention
Lenacapavir, originally developed by Gilead Sciences, is a twice-yearly injectable that has demonstrated exceptional effectiveness in preventing HIV. This pricing initiative brings its cost on par with oral PrEP — a critical factor for increasing uptake in low- and middle-income countries, Unitaid noted.
Rapid Regulatory and Global Endorsement
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) granted regulatory approvals for lenacapavir in record time. In July, the World Health Organization (WHO) issued a global recommendation, further paving the way for widespread adoption.
Expanding Manufacturing Capacity
In October 2024, Gilead granted royalty-free licenses to six generic manufacturers, including Dr. Reddy’s and Hetero, to produce and supply lenacapavir to the 120 target countries. The Hetero agreement also includes affordable access to the active pharmaceutical ingredient (API), enabling other generic makers to scale production quickly and meet global demand efficiently.