Hims & Hers announced on Saturday it would stop offering a compounded version of Novo Nordisk's oral Wegovy pill after constructive discussions with industry stakeholders.
The decision followed FDA threats of swift action, HHS referral to DOJ for potential violations of the Federal Food, Drug, and Cosmetic Act, and legal threats from Novo Nordisk.
Novo Nordisk sued Hims on Monday for patent infringement on compounded semaglutide products, alleging safety risks like up to 86% impurities in injectables and 75% in oral versions.
Hims had planned to launch the cheaper compounded pill ($49 first month, then $99/month) on Thursday, claiming a different formulation, but faced immediate backlash.
This retreat highlights ongoing tensions over compounded GLP-1 drugs post-shortage, with regulators cracking down on mass-marketed copycats of FDA-approved medications.