Novo Nordisk has reached confidential settlements with two Florida sellers of compounded versions of the mega-blockbuster semaglutide treatments Ozempic and Wegovy, the company said on Friday.
In June of last year, Novo filed trademark infringement lawsuits against five sellers of knockoff versions of the GLP-1 drugs, which have seen skyrocketing demand to combat weight loss. Ekzotica Corp.’s Cosmetic Laser Professionals Med Spa in Miami and Effinger Health’s Nuvida Rx Weight Loss in Tallahassee are the first two companies to have resolved their cases.
According to permanent injunction orders, the sellers will stop using Novo trademarks and have agreed to disclose for 12 months that compounded versions of the drugs have not gone through the safety and efficacy standards required by the FDA for approved drugs.
“The defendants’ unlawful marketing practices, including the use of misleading advertising and Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception, as well as potential safety concerns,” Novo Nordisk said in a statement. “Consistent with our commitment to patient safety, Novo Nordisk will continue to pursue legal action against other entities engaged in similar conduct.”
Still outstanding are 10 legal actions against medical spas and weight loss clinics that sell the knockoff products and pharmacies that produce compounded versions of the treatments.
In May of last year, the FDA warned consumers that compounding pharmacies—which are permitted to make copycat versions of drugs that are in shortage—were producing Ozempic and Wegovy knockoffs that did not contain approved ingredients.
In some cases, compounders were found using salt forms of semaglutide which have not been proven to be safe or effective.
In September, Eli Lilly filed eight lawsuits in five states against companies that it claimed are selling or producing compounded versions of tirzepatide, the active ingredient in its top-selling obesity treatments Mounjaro and Zepbound.