Generic HIV drug may cut cost down to $40/yr

A partnership will enable low-cost, generic lenacapavir for HIV prevention in LMICs, aiming to improve access and reduce infections significantly.

Millions of people at risk of HIV in low- and middle-income countries (LMICs) will soon have access to a powerful new prevention option, a low-cost, generic version of lenacapavir, the world’s first twice-yearly injectable pre-exposure prophylaxis (PrEP), said the Gates Foundation in a statement.

Generic HIV drug may cut cost down to $40/yr

“A new partnership announced today between the Gates Foundation and Indian manufacturer Hetero Labs (Hetero) — supported by upfront funding and volume guarantees — will enable the company to manufacture generic lenacapavir at roughly $40 per patient per year (after a short pre-treatment oral regimen), a price point designed to make the breakthrough treatment affordable for national health systems,” read the statement. That compares with around $28,000 (annually in the US) for the non-generic version made by Gilead Sciences.

Vamsi Krishna, managing director of Hetero Group of Companies, said in a statement: “Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir.”

“This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”

In addition, Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI also announced new commitments with another Indian manufacturer, Dr. Reddy’s Laboratories Ltd. (DRL), for the same drug, reinforcing efforts to build a competitive generics ecosystem. The accelerated development of a large-scale generic supply of lenacapavir, which is anticipated as early as 2027 pending regulatory approval, will reduce the time between initial doses and provide wider access to the drug, read the statement.

This move could potentially transform the fight against HIV and help end the epidemic faster and more equitably, experts believe.

The new collaborations complement agreements already in place between the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gilead Sciences; and the U.S. State Department through PEPFAR, and supported by 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.

Lenacapavir for PrEP — approved by the US FDA in June and the European Commission in August — offers six months of protection with a single injection, adding a powerful new prevention option for communities underserved by existing methods. Public health experts see it as a transformative option for people who face barriers to daily oral PrEP, including stigma, adherence challenges, and inconsistent access to medication.

According to estimates, 1.3 million people acquired HIV in 2024, and only 18% of people who could benefit from PrEP currently have access to it.

“Modelling suggests that the introduction of lenacapavir has the potential to prevent significant numbers of HIV infections. In fact, one study showed that scaling up access to affordable lenacapavir to just 4% of the population in high-burden countries could prevent up to 20% of new infections. That potential drives the urgency of this investment,” read the statement from the Gates Foundation.

As part of its broader commitment to ending deadly infectious diseases, the foundation has made more than $80 million in catalytic investments to accelerate market readiness, scale delivery, and shorten the timeline for generic entry of lenacapavir.

“Scientific advances like lenacapavir can help us end the HIV epidemic—if they are made accessible to people who can benefit from them the most,” said Trevor Mundel, president of global health at the Gates Foundation. “We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”

In 2024, Gilead Sciences granted royalty-free licenses for lenacapavir production to six generic manufacturers for 120 low- and middle-income countries. Following regulatory approvals, generic lenacapavir will flow through national HIV programs and public procurement channels such as the Global Fund. The Hetero agreement also includes an affordable supply of the active pharmaceutical ingredient (API), enabling other generic manufacturers to scale quickly and efficiently.