At a Glance
- Lawsuit claims patent breach on Wegovy/Ozempic ingredient.
- Hims pill launched then stopped quickly after FDA alert.
- Compounded drugs had up to 86% impurities per Novo tests.
- FDA and doctors warn of safety risks; real drugs available.
Written By: Pharmacally Medical News Desk
Novo Nordisk has filed a lawsuit in the United States against telehealth firm Hims & Hers, alleging patent infringement and unlawful promotion of compounded semaglutide products that pose serious risks to patient safety.
The lawsuit centers on alleged infringement of US Patent 8,129,343 and targets Hims’ marketing and sale of compounded versions of semaglutide, the active ingredient in Novo Nordisk’s FDA-approved medicines Wegovy and Ozempic.
Allegations of Deceptive Marketing and Unsafe Products
Novo Nordisk claims that Hims has engaged in promotional campaigns that mislead consumers and healthcare professionals about the safety and effectiveness of its compounded semaglutide offerings. According to the company, these products are unapproved, mass compounded, and made using inauthentic active pharmaceutical ingredients.
The complaint also highlights Hims’ recent launch of a so-called “Compounded GLP-1 Pill,” which was abruptly discontinued just two days later. Novo Nordisk alleges this move followed closely after its own introduction of a Wegovy pill, described as the first and only FDA-approved oral GLP-1 treatment for weight loss.
Despite discontinuing the pill, Novo Nordisk says Hims continues to mass compound injectable semaglutide products, putting patients at risk through products that bypass the FDA’s regulatory review process.
Safety Risks Linked to Compounded Semaglutide
Novo Nordisk presented internal testing data showing serious quality concerns with compounded semaglutide products. According to the company, injectable compounded versions contained impurities of up to 86 percent, while compounded oral formulations showed impurity levels as high as 75 percent.
Even small amounts of such impurities can compromise drug safety and effectiveness. Reported risks include severe immune reactions such as anaphylaxis, hospitalization, overdoses, and dangerous drug-drug interactions.
“Throughout Novo Nordisk’s 103-year-long history, patient safety has always been our top priority,” said John F. Kuckelman, Senior Vice President and Group General Counsel at Novo Nordisk. He added that mass marketing of unapproved knock-off versions of Wegovy and Ozempic is dangerous, deceptive, and undermines scientific and regulatory standards designed to protect patients.
FDA and Medical Community Raise Similar Concerns
Novo Nordisk’s legal action follows recent statements from the Food and Drug Administration, which warned that mass-marketed compounded GLP-1 drugs are products for which the agency “cannot verify quality, safety, or efficacy.”
Major medical organizations have echoed these concerns. The American Medical Association, American Diabetes Association, and the Endocrine Society have all raised alarms about the risks associated with knock-off GLP-1 products. The ADA has explicitly recommended against their use, citing uncertainty around content, quality, safety, and effectiveness.
Broader Patient Safety Efforts
The lawsuit builds on Novo Nordisk’s multi-year campaign to protect patients from unsafe compounded medicines. These efforts include prior legal actions and public education initiatives such as “Check Before You Inject” and “Choose the Real Thing,” which aim to raise awareness about the dangers of unapproved drugs made with foreign or inauthentic ingredients.
Novo Nordisk also emphasized that supply constraints are no longer a factor. The company stated that all doses of FDA-approved Wegovy, in both pill and injectable forms, as well as Ozempic, are fully available nationwide in the US.
With approved treatments readily accessible, Novo Nordisk warned that patients should not risk their health by turning to unverified and potentially dangerous compounded alternatives.
For additional information on Novo Nordisk’s patient safety initiatives, the company directs patients and healthcare professionals to semaglutide.com.
References
Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy® and Ozempic®, 09 February 2026, News Details