GILD · News · 20261102N

HIV Prevention Access Expansion

GILEAD SCIENCES, INC. · 2026-11-02 · Importance 31 · Surprise 42

Dr. Reddy’s received tentative U.S. FDA approval for generic lenacapavir, a twice-yearly injectable HIV-prevention drug, under the PEPFAR program and a voluntary licensing agreement with Gilead. The licensing arrangement is expected to make the medicine available in 120 countries outside the United States, with initial supplies anticipated by the end of 2026 and broader availability in 2027. One report put the price at $40 per person per year, positioning the injection as an infrequent-dose prevention option for people in low- and middle-income countries.

Key facts

• The first supplies of Dr Reddy’s generic lenacapavir under its voluntary licensing agreement with Gilead were anticipated before the end of 2026. source
• The first supplies of lenacapavir under the voluntary licensing agreement with Gilead were expected before the end of 2026, with broader availability in 2027. source