In a significant move poised to transform global health, Hyderabad-based pharmaceutical giants Dr. Reddy’s Laboratories and Hetero Labs have independently secured agreements to manufacture and distribute a generic version of Gilead Sciences’ groundbreaking HIV prevention drug, Lenacapavir. This innovative treatment will be made available for an astounding annual cost of just $40 in 120 low- and middle-income countries, with distribution commencing in 2027.
Dr. Reddy’s partnership with global health organizations Unitaid, the Clinton Health Access Initiative (CHAI), and research institute Wits RHI is crucial to this initiative, ensuring that injectable Lenacapavir reaches those in need at this accessible price point.
Meanwhile, the Gates Foundation has independently announced a separate agreement with Hetero Labs. This deal provides upfront funding and volume guarantees, empowering Hetero to produce generic Lenacapavir at approximately $40 per patient annually (following a brief oral pre-treatment phase). The Foundation emphasized that this strategic pricing makes the revolutionary treatment attainable for national healthcare systems in developing nations.
Lenacapavir, originally pioneered by Gilead Sciences, is a highly effective, twice-yearly injectable medication for HIV prevention. This new agreement marks a milestone, as it aligns the cost of the injectable drug with that of oral pre-exposure prophylaxis (PrEP), a critical factor for widespread adoption in low- and middle-income regions.
The drug has already received swift regulatory approval from major bodies, including the U.S. Food and Drug Administration and the European Medicines Agency. Furthermore, the World Health Organization (WHO) issued a global recommendation for Lenacapavir in July, underscoring its recognized importance.
CHAI and Unitaid played a pivotal role in brokering this agreement, offering Dr. Reddy’s comprehensive financial, technical, and regulatory backing. This support will enable the delivery of affordable, quality-assured generic Lenacapavir to these countries by 2027 – remarkably, less than two years after Gilead’s original product received regulatory clearance in higher-income nations.
Last year, in October 2024, Gilead had already extended royalty-free licenses to six generic manufacturers for Lenacapavir production aimed at these 120 countries. The Gates Foundation noted that Hetero’s agreement further enhances this effort by guaranteeing an affordable supply of the active pharmaceutical ingredient, which will significantly accelerate the ability of other generic producers to ramp up manufacturing.