Novo Nordisk is suing several medical spas, weight loss clinics and compounding pharmacies for allegedly selling products claiming to contain semaglutide, a key ingredient in the Danish drugmaker’s popular weight loss drug Wegovy and diabetes medication Ozempic.

In a June 20 press release, the pharmaceutical company announced legal action over “false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products,” saying that the “unlawful marketing and sales practices” have “created a high level of consumer confusion and deception, as well as potential safety concerns.”

Novo Nordisk – which has its U.S. headquarters in Plainsboro – filed five federal lawsuits in New York, Texas, Florida and Tennessee seeking orders to block sales of the unauthorized drugs as well as unspecified monetary damages, Reuters reported.

The filings come about a month after the U.S. Food and Drug Administration (FDA) warned about the safety risks of using unauthorized versions of the drugs, saying it has received reports of adverse health reactions related to modified, or “compounded,” variations. The May 31 notice was prompted by the growing number of consumers who have turned to compounding pharmacies for cheaper, copycat versions of semaglutide amid a continuing shortage of Ozempic and Wegovy.

Approved by the FDA in 2017, Ozempic is a self-injectable treatment for adults with Type 2 diabetes that works by mimicking a natural hormone the body releases when a person eats, potentially causing weight loss as a secondary effect.

Wegovy was authorized in June 2021 specifically for chronic weight management in adults who are obese or overweight with at least one weight-related condition, such as high blood pressure, Type 2 diabetes or high cholesterol. The drug was on the market for about six months when Novo Nordisk announced it was in short supply, attributing the scarcity to an issue with its contracted manufacturer. After that, many physicians reportedly shifted to off-label prescriptions for semaglutide diabetes drugs Ozempic and Rybelsus for patients who needed or wanted to lose weight but could not access Wegovy.

Under federal law, compounding pharmacies are permitted by the FDA to prepare compounded versions of medications currently listed in short supply.

However, the agency recently emphasized that compounded semaglutide is neither FDA-approved or evaluated for safety, effectiveness or quality, and that there are only three authorized products available by prescription only: injectables Ozempic and Wegovy, and oral tablet Rybelsus.

Doug Langa, executive vice president, North America operations and president of Novo Nordisk, said in a June 20 statement, “Our priority is to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines, and these actions are a direct reflection of that focus.”

Earlier this month, Novo Nordisk told NJBIZ it was considering legal action against companies over the off-brand versions, noting that, as the sole patent holder of semaglutide, it does not sell that ingredient to outside entities. The drugmaker is also ramping up efforts to reinforce the responsible use of its FDA-approved medicines, which includes a newly launched resource hub with information on semaglutide that offers ways to spot a counterfeit injectable product.

“We believe it’s important to provide additional tools and education to support the proper use of our approved semaglutide products and create broad public awareness regarding the difference between our FDA-approved medicines and other products being labeled as semaglutide,” Langa stated.