USA — Novo Nordisk has filed a lawsuit against Wells Pharmacy Network, alleging misleading marketing of semaglutide compounded drugs.
The legal action accuses the Florida-based pharmacy of selling “adulterated and misbranded” drugs, falsely claiming to contain semaglutide, the active ingredient in Novo’s diabetes and weight loss medications, Ozempic and Wegovy.
Novo contends that while compounded drugs are permissible in the U.S. for specific patient needs, Wells engaged in improper marketing practices, creating a false impression of FDA approval.
The lawsuit argues that compounded drugs lack the safety assurances of FDA-approved drugs, posing potential health risks to patients. Novo’s tests revealed “unknown impurities” and the presence of BPC-157 in Wells’ products, raising concerns about patient safety.
Novo Nordisk seeks a permanent injunction to halt what it considers Wells Pharmacy Network’s “unlawful and unfair business practices” that could endanger patient health. Wells has not responded publicly.
Simultaneously, Novo has refiled a similar complaint against Brooksville Pharmaceuticals in Florida. Matthew Modafferi, representing Brooksville, states that the company disputes the allegations.
Previously obtaining preliminary injunctions against six medical spas and clinics, Novo aimed to prevent the improper marketing of compounded drugs as authentic Ozempic and Wegovy.
In a parallel development, Eli Lilly, Novo’s rival, obtained a preliminary injunction against a Minnesota medical spa marketing compounded drugs containing tirzepatide.
Counterfeit versions of drugs like Ozempic have surged globally, with at least 17 countries reporting cases. Law enforcement and health officials have issued warnings due to the uncertainties and potential health risks associated with these counterfeit drugs.
Wegovy, Novo Nordisk’s weight-loss drug with the same active ingredient — semaglutide — as Ozempic, was shown to help patients lose an average of 15 percent of their weight in a late-stage trial.
The scramble for supplies of the powerful pound-shedding molecule has led to shortages of Ozempic in several countries including Britain, Germany, Belgium and the United States.
A source familiar with anti-counterfeiting efforts told Reuters last month that markets where sales of fake weight-loss drugs were most prevalent included Lebanon and other countries in the Middle East.
Several people have been hospitalized in Austria for hypoglycemia after taking potentially fake versions of Ozempic.
The health safety regulator there said the side effects indicated the product contained insulin instead of semaglutide.
Last month, Belgium’s drug regulator said it had seized counterfeit versions of Ozempic in which the injector pens were confirmed to contain insulin.