Novo Nordisk (NYSE:NVO) has filed a patent infringement lawsuit against telehealth provider Hims & Hers (NYSE:HIMS) in the United States, targeting the company’s sale and promotion of compounded semaglutide products, according to a statement from the Danish drugmaker.
Novo Nordisk alleges that Hims & Hers violated U.S. Patent 8,129,343 by marketing compounded versions of semaglutide that it says copy its FDA-approved diabetes and obesity treatments Wegovy and Ozempic. The company argues that these products are unapproved alternatives promoted outside the FDA’s regulatory framework.
The lawsuit seeks a permanent injunction to stop Hims & Hers from selling what Novo Nordisk describes as infringing compounded drugs, along with financial damages.
“Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process,” said John F. Kuckelman, senior vice president at Novo Nordisk.
Novo Nordisk said internal tests found that injectable compounded semaglutide products from pharmacies contained impurity levels of up to 86%, while compounded oral versions showed impurities as high as 75%, raising concerns about safety and effectiveness.
The legal action follows Hims & Hers’ recent rollout—and subsequent withdrawal—of its “Compounded GLP-1 Pill,” which came shortly after Novo Nordisk launched its Wegovy pill, described as the first FDA-approved GLP-1 pill for weight loss.
According to the statement, several medical organizations, including the American Medical Association, the American Diabetes Association and the Endocrine Society, have also raised concerns about the use of compounded GLP-1 drugs.
Novo Nordisk added that all doses of Wegovy and Ozempic are currently available nationwide across the U.S.