Overview
- Novo Nordisk filed a patent infringement case in U.S. District Court in Delaware seeking a permanent injunction and damages over Hims & Hers’ compounded versions of its semaglutide drugs.
- Hims & Hers withdrew its newly launched $49 compounded semaglutide pill after the FDA signaled enforcement, HHS referred the matter to the Justice Department, and the agency moved to restrict GLP‑1 ingredients in non‑approved compounded drugs.
- Novo’s general counsel accused Hims of mass marketing unapproved knockoffs that bypass FDA review, while Hims called the lawsuit a blatant attack on access to personalized compounding and vowed to fight it.
- Shares moved on the developments, with Novo Nordisk rising roughly 6%–9% and Hims & Hers falling in the mid‑teens to about 20% following the FDA actions and lawsuit.
- The dispute follows the FDA’s 2025 declaration that semaglutide is no longer in shortage and comes as analysts say enforcement could curb compounded GLP‑1 copycats, with Novo’s semaglutide patents reported to run through 2032.