FDA gives tentative approval to generic lenacapavir for low‑income countries
The U.S. Food and Drug Administration issued a tentative approval for a generic version of lenacapavir, the twice‑yearly HIV‑prevention shot originally developed by Gilead Sciences. The generic, created by Dr. Reddy’s Laboratories, will be sold at $40 per year in 120 low‑ and middle‑income countries. The branded version, Yeztugo, remains under patent in the United States with a list price of $28,218 per year.
Why it matters
The tentative approval allows the generic to be marketed outside the U.S., potentially expanding access to HIV prevention in emerging markets and putting pressure on Gilead’s pricing in those regions. However, the generic cannot be sold in the United States while the patent on Yeztugo remains in force.
Key facts
- 1The FDA granted a tentative approval for a generic version of lenacapavir for use in 120 low‑ and middle‑income countries. dailygazette.com
- 2The generic drug is priced at $40 per year per person in the target countries. dailygazette.com
- 3Gilead’s branded version, Yeztugo, lists at $28,218 per year before insurance in the United States. dailygazette.com
- 4The generic was developed by India‑based Dr. Reddy’s Laboratories under a partnership with Unitaid and the Clinton Health Access Initiative. dailygazette.com
- 5Because Yeztugo remains under patent, the generic cannot be sold in the United States. dailygazette.com
- 6The generic is expected to become available in some markets within weeks, subject to local approvals. dailygazette.com
Summary written by AlphAI AI Desk from 8 of 8 sources. Not investment advice. Figures are as stated by the linked sources.