Novo Nordisk filed a patent infringement lawsuit against Hims & Hers on February 9, 2026, alleging violation of US Patent No. 8,129,343 through marketing and sale of compounded semaglutide products mimicking Wegovy and Ozempic.13
Novo claims Hims' compounded products use inauthentic APIs, contain high impurities (up to 86% in injectables, 75% in orals), posing safety risks like immune reactions and overdoses.1
Hims briefly launched a compounded oral GLP-1 pill competing with Novo's FDA-approved Wegovy pill but discontinued it; continues offering compounded injectables.13
FDA announced enforcement actions in early February 2026 to restrict mass-marketed compounded GLP-1 drugs, targeting misleading ads and unverified quality, now that shortages of branded products have ended.12
This lawsuit and FDA moves signal a tightening regulatory environment for telehealth and compounding pharmacies offering GLP-1 alternatives.12
Sources:
1. https://www.hmpgloballearningnetwork.com/site/pln/news/novo-nordisk-sues-hims-hers-fda-moves-restrict-compounded-glp-1-drugs
2. https://www.bipc.com/oral-semaglutide-and-the-glp-1-compounding-reckoning-from-regulatory-ambiguity-to-fda-enforcement,-doj-referrals,-and-novo-nordisk%E2%80%99s-case-against-hims-and-hers
3. https://www.statnews.com/pharmalot/2026/02/09/novo-sues-hims-infringing-wegovy-patent-obesity/