Indian pharmaceutical companies Dr. Reddy's Laboratories and Hetero Labs announced they will roll out generic versions of a breakthrough HIV prevention drug for approximately $40 per year starting in 2027.
The medicine, lenacapavir, developed by Gilead Sciences and marketed under the brand name Yeztugo, is a twice-yearly injectable that demonstrated nearly 100% effectiveness in large clinical trials. Some HIV specialists, including doctors and activists, believe it could play a pivotal role in curbing the epidemic that continues to infect 1.3 million people annually and has claimed an estimated 44 million lives, according to the World Health Organization.
At $40 per year, the generic will be priced dramatically lower than the estimated U.S. cost of $28,000 annually for branded Yeztugo. The initiative is supported by global health agencies and foundations: Unitaid is providing technical and financial assistance to Dr. Reddy’s, while the Clinton Health Access Initiative and South Africa’s Wits Reproductive Health and HIV Institute (Wits RHI) are also partnering. Hetero’s program is receiving support from the Gates Foundation.
“Generic manufacture of lenacapavir is essential to ensure this breakthrough HIV prevention option is not limited to a privileged few,” said Professor Saiqa Mullick, director of implementation science at Wits RHI.
The two Indian drugmakers are among six companies granted royalty-free licenses by Gilead in 2023, allowing them to manufacture and supply the medicine across 120 low- and lower-middle income countries with the highest HIV burden by 2027, subject to approvals.
“The ($40) price that we have negotiated... brings the product in parity with the cost of the oral PrEP,” explained Carmen Perez Casas, Unitaid’s strategic lead for HIV. She noted that six-monthly injections could be especially beneficial for individuals who face challenges in adhering to daily oral medication due to stigma or logistical barriers.
However, access gaps remain. Upper-middle income countries, including several in Latin America, were excluded from Gilead’s licensing agreements, despite some like Brazil having participated in clinical trials. “We are supporting organizations and countries to reflect on how we could overcome those access barriers (in excluded nations),” Casas added.
Gilead is already working with the Global Fund to Fight AIDS, Tuberculosis and Malaria and the U.S. government to provide its branded injection at reduced prices to about 2 million people beginning this year. Yet experts project that long-term demand could exceed 10 million people, underscoring the importance of affordable generics at scale.
“The availability of generics at an affordable price... will magnify the impact of this game-changing innovation,” said Peter Sands, chief executive of the Global Fund.