GILD · News · 20261102N

HIV PrEP Licensing Expansion

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

The US FDA granted Dr. Reddy’s tentative approval for generic lenacapavir, which is being made available through a voluntary licensing agreement with Gilead under the PEPFAR program. The agreement is expected to enable availability in 120 countries outside the United States. The drug is priced at $40 per person per year, with initial supplies expected before the end of 2026 and broader availability in 2027.

Key facts

• Under a voluntary licensing agreement with Gilead, Dr Reddy’s twice-yearly injectable lenacapavir was expected to be available across 120 countries for $40 per person per year. source
• Under a voluntary licensing agreement with Gilead, Dr Reddy’s generic lenacapavir is expected to be made affordably accessible for HIV prevention in 120 countries outside the US. source