HIV: The first generic of the six-monthly injection drops to $40 per year for 120 countries

Indian pharmaceutical company Dr. Reddy's Laboratories has received tentative approval from the U.S. Food and Drug Administration (FDA) for the first generic version of injectable lenacapavir, used for HIV prevention, Unitaid announced from Geneva on November 2, 2026. The product will be offered at $40 per person per year in the 120 low- and middle-income countries covered by Gilead's voluntary license.

The principle involves two injections per year, whereas traditional prevention requires a daily pill. Unitaid describes lenacapavir as a "highly effective" treatment; the CEO of the organization CHAI, Dr. Neil Buddy Shah, describes it as "almost 100% effective in preventing HIV."

Sixteen months instead of several years

Gilead's original product was authorized by the FDA in June 2025. Sixteen months later, a generic is ready—an unusually short timeframe in the history of HIV medications, where African countries have often waited years to see affordable versions arrive. "We helped bring this timeline down to just over a year," says Unitaid Executive Director Dr. Philippe Duneton. At the end of 2024, Gilead granted voluntary licenses to six generic manufacturers, including Dr. Reddy's.

125,000 people already treated in ten African countries

According to Unitaid, more than 125,000 people have already started Gilead's lenacapavir in ten pioneering African countries, which Unitaid does not name. It is on the continent, which bears the heaviest burden of the epidemic, that the stakes are most direct: prevention that requires only two appointments per year changes the lives of people living far from a health center.

Two caveats are necessary. The authorization obtained is a tentative approval, a standard FDA formula for a generic as long as the original product remains under patent. And the first deliveries are not expected in countries until before the end of 2026, with wider availability announced for 2027.

Professor Saiqa Mullick, Director of Implementation Science at Wits RHI (University of the Witwatersrand, South Africa), warns that "an affordable drug is not enough": health systems capable of offering it where people live are also required. Unitaid cites the Global Fund and the Gates Foundation among the partners for the rollout.

The question that this timeline implicitly raises remains: why does a $40 price tag still depend on the scope that a patent holder chooses to grant, rather than on production capacity established on the continent?