By VETTAPHARMA reporter: Novo Nordisk has initiated a significant legal action in the United States against telehealth company Hims & Hers, alleging the mass marketing of unapproved and unsafe compounded versions of its semaglutide-based medicines Wegovy® and Ozempic®, which are widely used for weight management and type 2 diabetes care. The company says the unauthorized products infringe U.S. Patent No. 8,129,343 and place patient safety at risk.
In the lawsuit, Novo Nordisk alleges that Hims & Hers has “unlawfully mass marketed unapproved versions” of semaglutide drugs that do not meet the FDA’s rigorous scientific and regulatory approval standards. According to the company’s announcement, these compounded products have been promoted as though they offer the same benefits as FDA-approved medications, potentially deceiving consumers and healthcare professionals.
The complaint highlights safety concerns, stating that testing by Novo Nordisk found compounded injectable semaglutide products containing impurities of up to 86%, while compounded oral semaglutide drugs contained impurities as high as 75%. The company warns that such contaminants — or incorrect drug amounts — may lead to serious health consequences including immune reactions, hospitalization, and overdoses.
Novo Nordisk is seeking a permanent injunction against Hims & Hers to stop the sale of these knock-off drugs and is pursuing damages in the lawsuit. The company emphasized its ongoing collaboration with regulators, law enforcement, and other key stakeholders to ensure patients have access only to FDA-approved, safe, and effective medicines.
The action builds on Novo Nordisk’s multi-year efforts to raise awareness of risks posed by unapproved compounded products, including education initiatives like “Check Before You Inject” and “Choose The Real Thing,” which aim to caution patients about the dangers of unverified drug formulations.
The lawsuit comes at a time when Novo Nordisk’s widely approved treatments, including Wegovy® and Ozempic®, are fully available across the United States. The company stated that there is no medical justification for patients to use unapproved knock-offs when safe, tested options are accessible nationwide.
Novo Nordisk, founded more than a century ago, markets its therapies in approximately 170 countries and employs around 68,800 people globally — positioning itself as a leader in diabetes and obesity care and committed to protecting both its intellectual property and patient health.
Source credit:
- Novo Nordisk. (2026, February 9). Novo Nordisk takes legal action against Hims & Hers to protect patients from unsafe, knock-off Wegovy® and Ozempic®. Click here
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