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NewsWPLG Local 10November 2, 2026Miami-Dade County

FDA approves generic version of biannual HIV-prevention shot lenacapavir for 120 low- and middle-income countries

Photo: WPLG Local 10

The U.S. Food and Drug Administration approved a generic version of the biannual HIV-prevention shot lenacapavir, which is expected to cost $40 a year in 120 low- and middle-income countries. The generic version cannot be sold in the U.S. due to an active patent held by Gilead Sciences for its brand-name equivalent, Yeztugo, which lists at $28,218 annually. The approval is designated as 'tentative' and was developed by India-based Dr. Reddy’s Laboratories to expand access and lower costs.

HealthGlobal HealthPharmaceuticalsInfectious Diseases
Read the full story at WPLG Local 10

Why It Matters

Millions of people at high risk of HIV in 120 low- and middle-income countries gain access to a preventive injection priced at $40 annually, compared to the $28,218 U.S. list price for the patented equivalent.

Key Facts

Each fact below is taken from the article. Click one to see the exact passage.

Who's Mentioned

OrganizationU.S. Food and Drug Administration“The federal agency that granted tentative approval for the generic drug.”PersonCarolyn Amole“Quoted regarding scaling PrEP access to 20 million people.”OrganizationUnitaid“A global health agency that brokered agreements and funded efforts to accelerate”PersonSaiqa Mullick“Commented on the necessity of HIV testing prior to starting lenacapavir.”OrganizationDr. Reddy’s Laboratories“An India-based pharmaceutical company that developed the generic version under a”OrganizationWorld Health Organization“Reported that 41 million people were living with HIV and 570,000 died from HIV-r”PersonCarmen Pérez Casas“Quoted in the article regarding the hope provided by lenacapavir.”OrganizationWits RHI“A health research institute involved in brokering the development agreement.”PersonGerald Imray“Journalist who contributed reporting.”OrganizationGilead Sciences“Holds the active patent for the brand-name version in the U.S. and established r”OrganizationClinton Health Access Initiative“A global health organization involved in the partnership to develop the generic ”