• Source: www.mytwintiers.com

NEW YORK, Sept. 24, 2025—Millions of people at risk of HIV in low- and middle-income countries will soon gain access to a new HIV prevention tool: a low-cost, generic version of lenacapavir, the first twice-yearly injectable pre-exposure prophylaxis (PrEP).

The Bill & Melinda Gates Foundation announced a partnership with Indian pharmaceutical manufacturer Hetero Labs to produce generic lenacapavir at about $40 per patient per year, following a short oral regimen. The agreement, backed by upfront funding and volume guarantees, is designed to make the breakthrough drug affordable for national health systems.

“Hetero is pleased to partner with the Gates Foundation to create a pathway for the sustainable and affordable supply of lenacapavir,” said Dr. Vamsi Krishna, managing director of Hetero Group of Companies. “This collaboration reflects our commitment to ensuring access to innovative HIV medicines for patients in India and other low- and middle-income countries.”

Generic lenacapavir priced at $40

The injection, approved by the U.S. Food and Drug Administration in June and by the European Commission in August, offers six months of HIV prevention tool from a single dose. Public health experts see it as a transformative option for people unable to take daily oral PrEP due to stigma, adherence issues, or inconsistent access to medication.

Despite progress in reducing HIV rates and AIDS-related deaths since 2000, the World Health Organization reported 1.3 million new HIV infections in 2024. Only 18 percent of people who could benefit from PrEP currently have access. Modeling studies suggest that scaling up lenacapavir in high-burden countries could prevent up to 20 percent of new infections, even if only 4 percent of the population receives it.

Trevor Mundel, president of global health at the Gates Foundation, said the new agreement supports equity in treatment. “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,” he said.

Multiple groups strengthen supply chain

Alongside the Hetero deal, Unitaid, the Clinton Health Access Initiative, and Wits RHI announced commitments with Dr. Reddy’s Laboratories, another Indian manufacturer. The goal is to build a competitive generics market to accelerate large-scale supply, with generic production anticipated as early as 2027, pending regulatory approval.

These collaborations complement existing agreements between the Global Fund to Fight AIDS, Tuberculosis and Malaria; Gilead Sciences; and the U.S. State Department’s PEPFAR program. Supported by the Children’s Investment Fund Foundation (CIFF), these initiatives aim to deliver the first doses of lenacapavir to low- and middle-income countries by late 2025.

Kate Hampton, CEO of CIFF, said today’s announcements represent significant progress. “The deals announced today on generics are a major step forward in ending the HIV epidemic,” she said. “They build on full value-chain investments by CIFF and others to foster a competitive market so that access to lenacapavir is affordable and reliable for all those who need it.”

Building a generics ecosystem

In 2024, Gilead Sciences granted royalty-free licenses for HIV prevention tool lenacapavir production to six manufacturers for distribution across 120 low- and middle-income countries. The Hetero agreement also covers affordable supply of the active pharmaceutical ingredient, which will allow other companies to increase production quickly.

The Gates Foundation has invested more than $80 million to support market readiness, delivery systems, and early generic development. Earlier this week, Bill Gates announced a $912 million pledge to the Global Fund’s 2026–2028 replenishment campaign, which aims to save 23 million lives from HIV, tuberculosis, and malaria between 2027 and 2029.

The Bill & Melinda Gates Foundation has pledged to spend $200 billion over the next 20 years to accelerate progress in global health and poverty reduction. It will close its operations at the end of that period.