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India: generic lenacapavir production and access

This dossier follows Dr. Reddy’s generic lenacapavir, regulatory milestones and access in countries covered by Gilead’s licence.

Last updated : 1 key moments
Dr. Reddy’s logo.
Dr. Reddy’s logo, used for identification. Public domain (PD-textlogo). — Dr. Reddy’s / Wikimedia Commons — domaine public (PD-textlogo), logo d’identification, sans modification.

Where things stand

On 2 November 2026, tentative FDA approval was announced. Initial supplies are expected before the end of 2026; access still depends on national procedures.

Confirmed

HIV: Dr. Reddy’s injectable generic receives tentative approval

Indian manufacturer Dr. Reddy’s announced tentative FDA approval for its injectable lenacapavir for HIV prevention on 2 November 2026.

Dr. Reddy’s logo.
Dr. Reddy’s logo, used for identification. Public domain (PD-textlogo). — Dr. Reddy’s / Wikimedia Commons — domaine public (PD-textlogo), logo d’identification, sans modification.

Given twice yearly, the product is planned at $40 per person annually in the 120 countries covered by Gilead’s licence. Partners expect initial supplies before the end of 2026 and broader availability in 2027.

The decision does not permit US sales, where the original medicine remains protected. National authorisations and procurement will determine actual access.

Sources 4