Health

FDA grants tentative approval to cheaper generic HIV-prevention shot

Associated Press reports the generic version of lenacapavir is expected to cost $40 a year per person in 120 low- and middle-income countries.

Published Nov 2, 2026 · 15:44 UTC3 reports

The short version

The U.S. Food and Drug Administration has tentatively approved a generic version of the twice-yearly HIV-prevention shot lenacapavir for 120 low- and middle-income countries.[Associated Press]
The generic, developed by Dr. Reddy's Laboratories, is expected to cost $40 a year per person where available, versus a $28,218 U.S. list price for the brand-name Yeztugo.[Associated Press]
The generic cannot be sold in the United States because Gilead Sciences' brand-name version remains under patent.[Associated Press]

The FDA granted tentative approval to a generic version of the twice-yearly HIV-prevention shot lenacapavir for 120 low- and middle-income countries.[Associated Press]
The generic lenacapavir is expected to cost $40 a year per person in the countries where it will be available.[Associated Press]
The generic was developed by India-based Dr. Reddy's Laboratories under an agreement brokered by Unitaid, the Clinton Health Access Initiative, and Wits RHI.[Associated Press]
The brand-name version, Yeztugo, made by Gilead Sciences and approved last year, has a U.S. list price of $28,218 a year before insurance.[Associated Press]
Generic lenacapavir cannot be sold in the U.S. because the brand-name version remains protected by a patent.[Associated Press]

The approval is tentative, the FDA's standard designation for generics while the originator remains under patent.[Associated Press]
The $40 annual cost is an expected figure, not a confirmed final price, for countries where the generic will be available.[Associated Press]

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.