Overview
- Dr. Reddy’s and partner organizations said Monday that the U.S. Food and Drug Administration granted tentative approval to their generic lenacapavir for supply to about 120 low‑ and middle‑income countries.
- The generic is expected to cost roughly $40 per person per year in target countries compared with the branded product’s U.S. list price of about $28,000 per year.
- The FDA designation is “tentative” because Gilead’s branded version remains under U.S. patent so the generic cannot be sold in the United States.
- Partners expect initial shipments to begin in weeks or by the end of 2026 but warned that national regulatory reviews, procurement funding and delivery systems could delay local availability.
- Clinical guidance requires an HIV test before starting lenacapavir and before each injection because use in people with undiagnosed infection has been linked to drug resistance, and health‑system work is needed to translate approval into broad prevention impact.