Novo Nordisk sues two pharmacies for allegedly offering ...

Two compounding pharmacies in Florida are allegedly offering contaminated copycat versions of semaglutide, the drug found in Ozempic and Wegovy, Novo Nordisk said Thursday.

The claims are part of two lawsuits the drugmaker filed Wednesday night.

Semaglutide is exclusively patented by Novo Nordisk, and the drugmaker does not supply the ingredient to outside groups, which has raised questions about what other companies are selling to consumers.

Novo Nordisk said that it had conducted tests on the compounded products allegedly being sold as semaglutide from two Florida pharmacies, Wells Pharmacy and Brooksville Pharmaceuticals. One sample from Wells Pharmacy had a level of unknown impurities of 33%, and samples from Brooksville Pharmaceuticals had lower levels of the active ingredient than described on the label, along with impurities, according to the lawsuits.

“As I’ve warned patients for quite some time, these unregulated preparations are not equivalent to the brand name Wegovy and Ozempic,” said Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina. McGowan is not involved in the lawsuits.

In some instances, the products are “vastly different” from the FDA-approved versions and contain far less semaglutide, he said. “This means patients are exposing themselves to risk and lack of efficacy and are wasting their money.”

The lawsuits are a continuation of Novo Nordisk’s legal battle with clinics and compounding pharmacies offering what they say is semaglutide. Compounding pharmacies mix and alter ingredients to make medications tailored to a patient’s specific needs.

In June, the drugmaker filed five lawsuits against multiple medical spas, weight loss clinics and compounding pharmacies for allegedly selling unauthorized versions of the drug. On Thursday, the company said that, to date, it has successfully obtained preliminary injunctions against six spas and clinics that engaged in “false advertising and trademark infringement.”

Wells Pharmacy did not immediately respond to a request for comment.

Terry Myers, a pharmacist and owner of Brooksville Pharmaceuticals, dismissed Novo Nordisk’s claims about the level of active ingredient in the pharmacy’s semaglutide, saying in a statement that a third-party lab test found its formula remained “potent” for 180 days when stored in a refrigerator and 90 days when stored at room temperature. Myers also said that the pharmacy purchases all of its bulk ingredients from FDA-registered facilities.

“Our attorneys will be filing another motion to dismiss,” he said in a statement. A U.S. judge dismissed Novo Nordisk’s first lawsuit against Brooksville Pharmaceuticals in October.

Jamie Bennett, a spokesperson for Novo Nordisk, said that the company has not been able to confirm any adverse events related to either Wells Pharmacy’s or Brooksville Pharmaceuticals’ products.

The company’s lawsuits cite the Food and Drug Administration’s Adverse Event Reporting System, which showed that as of Sept. 20, there have been 281 cases of adverse events associated with compounded products that claim to contain semaglutide.

The public database includes reports from doctors and patients, though the reports have not necessarily been confirmed by the FDA.

About 75% of the cases were classified as “serious,” with a quarter of those cases leading to hospitalizations, two of which resulted in death, according to the lawsuits.

Mike Koelzer, a pharmacist and the owner of Kay Pharmacy in Grand Rapids, Michigan, noted that many patients have been eager to get the brand-name weight loss drugs. But due to shortages, many of them have been unable to access them.

Compounded versions of commercially available drugs are allowed under special circumstances, like a shortage, according to the FDA. Some doses of semaglutide are still listed as in shortage on the agency’s drug shortage database website.

“The world has managed without this specific drug for a long time, and while it’s certainly important, we must not rush its distribution at the cost of safety,” said Koelzer, whose pharmacy does not sell compounded drugs.

Berkeley Lovelace Jr.

Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.