Novo Nordisk ramps up legal case against compounding pharmacies selling ‘misbranded’ semaglutide

Novo Nordisk is taking another Florida pharmacy to court after allegedly finding impurities in its compounded drugs marketed as semaglutide, including one sample that was 33% impure, according to court documents.

It’s the latest in a string of lawsuits filed by Novo and its rival Eli Lilly in an attempt to stop wellness centers and compounding pharmacies from what they believe is improper marketing of the popular diabetes and weight loss products.

On Wednesday, Novo accused Wells Pharmacy Network in Wellington, FL, of selling “adulterated and misbranded” drugs claiming to contain semaglutide, the active ingredient in Ozempic and Wegovy. While compounded drugs are permitted in the US for patients who need their treatments altered in some way or if a medicine is in short supply, Novo argued that Wells misled patients to falsely believe its products were FDA-approved.

“Compounded products do not have the same safety, quality and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks,” Jason Brett, Novo Nordisk’s executive director of medical affairs, said in a news release.

In addition, Novo alleged that tests performed on its behalf revealed “unknown impurities” in Wells’ product, as well as a substance called BPC-157, which the FDA has associated with safety risks.

The company is seeking a permanent injunction to stop Wells from “unlawful and unfair business practices,” which Novo says put patients at risk. Wells did not immediately respond to a request for comment.

Novo also refiled a complaint in a similar case against Florida-based Brooksville Pharmaceuticals on Wednesday, arguing that its semaglutide products also contain unknown impurities and have a strength “at least 19% less than what is reported on its label.”

Matthew Modafferi, an attorney representing Brooksville in the case, told Endpoints News on Thursday that the company disputes the allegations and will seek to dismiss the case.

Novo has won preliminary injunctions against six medical spas and clinics preventing them from marketing compounded drugs as authentic Ozempic and Wegovy or as FDA-approved drugs. Lilly won a similar injunction earlier this month that temporarily blocked a Minnesota medical spa from using its Mounjaro trademark to advertise compounded drugs that contain tirzepatide.

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