Health

FDA clears first generic of breakthrough twice-yearly HIV prevention shot for 120 countries

Washington • November 2, 2026 • By Press Pass USA

Editorial illustration: a health worker in scrubs administering an injection to a seated patient in a bright modern clinic

Editorial illustration — Press Pass USA

The U.S. Food and Drug Administration has tentatively approved the first generic version of lenacapavir, a twice-yearly injection that prevents HIV and proved nearly 100% effective in large clinical trials — a milestone that could bring the breakthrough shot to millions of people in 120 low- and middle-income countries for $40 a year.

Indian drugmaker Dr. Reddy's Laboratories announced the tentative approval on Monday, Reuters reported. It is the first of six manufacturers licensed by Gilead Sciences, which developed the drug, to clear the FDA's review for a generic version.

Lenacapavir, sold in the United States under the brand name Yeztugo, was approved by the FDA in June 2025 after large trials showed it was more than 99.9% effective at preventing HIV, according to Unitaid, the global health agency hosted by the World Health Organization. The branded shot carries a U.S. list price of about $28,000 a year. The generic, by contrast, is expected to cost $40 per person per year — roughly the same as daily HIV prevention pills — under a pricing agreement reached in September 2025 between Unitaid, the research institute Wits RHI, the Clinton Health Access Initiative and Dr. Reddy's.

"Tentative approval" means the generic meets the FDA's safety, efficacy and quality standards but cannot yet be sold in the United States because the originator product remains under patent. The designation matters far beyond the U.S. market: it lets global procurement agencies and national regulators in other countries rely on the FDA's assessment when making their own purchasing and approval decisions, potentially fast-tracking the rollout.

"There are some countries who would be able to fast-track regulatory approvals based on a reliance mechanism on the US FDA," Jessica Burry, a technical officer at Unitaid, told Reuters, adding that the approval could also accelerate procurement. Initial supplies of the twice-yearly injection are expected to reach a few low-income countries by the end of 2026, she said, and Zambia could be among the first to receive it.

The broader rollout across the 120 countries covered by Gilead's voluntary licensing agreements is expected in 2027, Dr. Reddy's said. The generic's arrival comes just 16 months after the original product's approval — a strikingly short gap in global health, where people in lower-income countries have often waited a decade or more for breakthrough medicines already available elsewhere.

"This is an extraordinary milestone for global health. For too long, people in lower- and middle-income countries have had to wait a decade or more to access breakthrough medicines already available elsewhere," Carmen Perez-Casas, Unitaid's senior strategy lead for HIV and pandemic preparedness, told Agence France-Presse. "With lenacapavir, we've reduced that gap to little more than a year. Having an FDA-approved generic at $40 per person per year — a price comparable to daily HIV prevention pills — is a remarkable achievement."

Even before the generic arrives, more than 125,000 people in 10 early-adopter African countries have already started on Gilead's version of the drug, Unitaid said. Doctors and activists say the shot could help control an epidemic that still infects about 1.3 million people a year and that the WHO estimates has killed 44 million since it first emerged — in part because a shot given twice a year is far easier to stick with than a pill taken every day.

The partners behind the generic cautioned that approval alone will not guarantee access. National regulatory approvals, country-level introduction plans and funding still have to fall into place, and they said they are coordinating with governments, the Global Fund, the Gates Foundation and community groups on the rollout. Separately, Indian drugmaker Hetero is working with the Gates Foundation on its own generic lenacapavir.

Sources: Reuters (Nov. 2, 2026, full article verified); Agence France-Presse via MedicalXpress (Nov. 2, 2026); Unitaid news release, as reported by Managed Healthcare Executive (Nov. 2, 2026).