U.S. Approval Clears Path for Generic HIV Prevention Shot Priced at $40 a Year

Key Facts

The U.S. Food and Drug Administration on November 2, 2026, granted Dr. Reddy’s Laboratories tentative approval for the first generic version of a long-acting lenacapavir injection to prevent HIV. A partnership agreement will make the dose available for $40 per person per year in 120 low- and middle-income countries, according to the Clinton Health Access Initiative. The agreement aims to expand access to a drug administered twice a year, while oral prevention typically requires taking a pill daily. The approval comes 16 months after Gilead’s original product was approved for prevention, the initiative said. The tentative designation means the generic version does not receive U.S. marketing authorization while the original product remains protected by patent, according to The Associated Press.

Dr. Reddy’s developed the generic version with financial, technical and regulatory support from Unitaid, the Wits Reproductive Health Institute and the Clinton Health Access Initiative. The initiative said the price of $40 per person per year was set under an existing agreement for the countries covered, and differs from the U.S. list price for the original product. The Associated Press reported that Yeztugo’s U.S. price before insurance is $28,218 a year. The two figures reflect pricing in different markets and arrangements: the agreed generic price applies to the 120 countries, while the U.S. figure is a pre-insurance list price. Gilead announced in June 2025 that the U.S. administration had approved Yeztugo as a prevention option administered twice a year.

The dosing schedule is significant because it differs from the common daily regimen for oral prevention drugs: lenacapavir is given by injection twice a year. The Clinton Health Access Initiative said more than 125,000 people in 10 early-adopting African countries had already started using Gilead’s lenacapavir before the generic version became available. That figure offers an indication of the original product’s initial use in those countries, while the tentative approval opens a regulatory path for a generic version intended for low- and middle-income markets. The approval alone does not mean the drug is immediately available in every country covered. Practical expansion depends on access, financing and distribution arrangements in those markets.

Gilead received approval in 2025 for lenacapavir, sold under the brand name Yeztugo, for pre-exposure prevention in adults and adolescents weighing at least 35 kilograms who are at risk of sexually acquired HIV-1. The company said the PURPOSE 1 study recorded no infections among 2,134 participants who received the drug, while PURPOSE 2 recorded two infections among 2,179 participants in the lenacapavir group. Gilead said the latest available Centers for Disease Control and Prevention data at the time, for 2022, showed that only 36% of people eligible for drug-based prevention in the United States were receiving some form of it. These figures provide context for the original product’s approval, but relate to Gilead’s studies and data and are not independent results for the generic version. The U.S. label also requires testing for the virus before treatment begins and before each injection, after resistant strains were identified in people with undiagnosed infection.

Next steps include a separate path for prevention with the same drug: the U.S. administration is reviewing Gilead’s application for a potential once-weekly oral formulation, and the company has set February 2, 2027, as its target date for regulatory action. On international access, The Associated Press reported that the United States is buying doses for up to 2 million people in low-income countries by 2028 under the PEPFAR program. A U.S. State Department official said the program, in partnership with the Global Fund, hopes to help 2 million people start the drug in the three years following the announcement. This program is separate from the generic-version agreement, though both are tied to expanding access to lenacapavir. In the market, Gilead shares closed at $170.68 on October 30, 2026, according to EL7 data.