Novo Nordisk has announced the filing of 14 new lawsuits against the sale of unapproved compounded drugs claiming to contain semaglutide, an active ingredient in its weight-loss and diabetes drugs, Wegovy and Ozempic, respectively.
The focus of these US lawsuits is on compounding pharmacies, telehealth companies, and medical spas, reported .
The lawsuits claim that defendants deceive patients into believing compounded products have been reviewed and approved by the US Food and Drug Administration (FDA) or are as safe and effective as Novo Nordisk’s approved semaglutide medicines.
They also allege violations of state corporate practice of medicine laws, accusing telehealth providers of improperly influencing doctors’ decisions.
Novo Nordisk US operations’ executive vice-president Dave Moore said: 鈥淧atients deserve safe, effective treatments from companies they can trust. No one should have to聽gamble聽with their health by using knockoff drugs made with ingredients that lack oversight and safety standards.
“Novo Nordisk is addressing this issue through education, advocacy, and legal action against businesses that mislead Americans and jeopardise their health with unsafe and unapproved knockoffs. We urge regulators to enforce laws designed to protect public health.”
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By GlobalDataThe company has so far filed 132 complaints in federal courts across 40 US states.
The latest lawsuits expand the focus to pharmacies producing unapproved compounded semaglutide drugs and telehealth companies improperly steering patient care to these drugs by utilising fake claims of personalisation.
Courts have issued 44 permanent injunctions against defendants in similar cases, prohibiting unlawful conduct, including the sale of unauthorised compounding of semaglutide and the false representation that compounded semaglutide products are FDA-approved, safe, or equivalent to Novo Nordisk’s drugs such as Wegovy or Ozempic.
The FDA has issued several alerts, including one on 29 July, warning about the dangers of these knockoff drugs. Reports include patients overdosing and requiring hospitalisation.
Novo Nordisk stated that it has launched educational campaigns to raise awareness about the risks of unapproved knockoffs.
The company also created semaglutide.com as a resource for patients to learn about the dangers of compounded and counterfeit products.
With all doses of Wegovy and Ozempic available across the US, the company stated that it continues to explore new channels to ensure patients can access safe, effective treatments under the supervision of licensed healthcare professionals.
Last month, Novo Nordisk lost a US patent to generics manufacturer Viatris.
A聽federal district court in Delaware聽ruled that Viatris鈥� product, currently awaiting approval from the FDA, does not infringe on Novo Nordisk鈥檚 patent for Wegovy.
