Dr. Reddy’s, Hetero to supply Gilead’s HIV drug Lenacapavir at $40 

Hyderabad-based drugmakers Dr. Reddy’s Laboratories and Hetero Labs have signed separate agreements that will make their generic version of Gilead Sciences’ HIV prevention drug Lenacapavir available at $40 a year in 120 low- and middle-income countries beginning 2027.

Injectable lenacapavir will be available at $40 a year in these countries under a new partnership between Dr. Reddy’s and Unitaid, the Clinton Health Access Initiative (CHAI) and research institute Wits RHI.

Separately, the Gates Foundation and Hetero Labs announced an agreement under which supported by an upfront funding and volume guarantees the company will manufacture generic lenacapavir at roughly $40 per patient per year (after a short pre-treatment oral regimen). The price point is designed to make the breakthrough treatment affordable for national health systems, the Foundation said.

Originally developed by Gilead Sciences, lenacapavir is a twice-yearly injection that has shown exceptional effectiveness in preventing HIV. The agreement now brings the price of the injectable on a par with oral PrEP, a key condition for uptake in low- and middle-income countries, Unitaid said in a release.

The U.S. Food and Drug Administration and European Medicines Agency provided regulatory approvals in record time. The World Health Organization followed suit, issuing a global recommendation for lenacapavir in July.

“The agreement, brokered by CHAI and Unitaid, provides Dr. Reddy’s with financial, technical and regulatory support to deliver affordable, quality-assured generic versions of lenacapavir to low- and middle-income countries by 2027, following regulatory approval. That is just less than two years after the regulatory approval of Gilead’s product in high-income countries,” it said.

In October 2024, Gilead granted royalty-free licenses for lenacapavir production to six generic manufacturers to supply to the 120 countries. The Hetero agreement also includes an affordable supply of the active pharmaceutical ingredient, enabling other generic manufacturers to scale quickly and efficiently, the Gates Foundation said.