FDA grants tentative approval for Dr. Reddy's generic of Gilead's HIV drug Yeztugo
The U.S. Food and Drug Administration issued a tentative approval for Dr. Reddy's Laboratories to market a generic version of Gilead Sciences' HIV preventative medicine Yeztugo (lenacapavir). The clearance permits sales in 120 low‑ and middle‑income countries, with the first shipments expected by the end of 2026. Unitaid projects the generic will cost about $40 per person‑year. This is the first generic authorization for Yeztugo.
Why it matters
The lower‑priced generic could expand access in emerging markets and reduce Gilead's pricing power, while providing Dr. Reddy's a new revenue stream. The approval also signals regulatory support for broader HIV prevention in LMICs.
Key facts
- 1The FDA granted tentative approval for Dr. Reddy's generic version of Yeztugo (lenacapavir). tradingview.com
- 2The approval allows marketing in 120 low‑ and middle‑income countries. tradingview.com
- 3Supplies of the generic are expected by late 2026. tradingview.com
- 4Unitaid estimates the generic's cost at $40 per person‑year. tradingview.com
- 5It is the first generic approval for Gilead's Yeztugo. seekingalpha.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.