Seven weeks after a federal judge dismissed (PDF) a Novo Nordisk’s lawsuit, which accused a Florida pharmacy of selling unauthorized knockoffs of its GLP-1 drugs Wegovy, Ozempic and Rybelsus, Novo has sued the same company.
Brooksville Pharmaceuticals is the target of a refiled Novo lawsuit, this one claiming there are impurities in the company’s compounded versions of the popular diabetes and weight-loss treatments. Earlier this month, Florida judge William Jung gave Novo three weeks to renew its complaint against Brooksville.
In addition, Novo is suing another Florida company, Wells Pharmacy. In both complaints, Novo says that the companies are selling adulterated versions of the treatments that contain BPC-157, a peptide that promotes gastrointestinal healing but has not been sanctioned for use in compounded products because of safety risks.
In September, the FDA clarified its ban on BPC-157, saying it would “consider taking action against a compounder” for using it or other bulk drug substances in its classification.
Novo also says that the compounded versions from Wells and Brooksville contain at least 19% less semaglutide—the active ingredient in Wegovy, Ozempic and Rybelsus—than promised on their labels.
“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’s executive director of medical affairs, said in a release.
The complaints continue a feud between Novo Nordisk and companies accused of selling unauthorized versions of GLP-1 drugs. In June, Novo filed lawsuits against five companies in four states, charging them with false advertising, trademark infringement and unlawful sales. A month later, Novo alleged that four more companies, including Brooksville, were doing the same.
In September, Eli Lilly got into the act, filing lawsuits against eight companies in the U.S. who are accused of producing or selling compounded versions of the popular GLP-1/GIP drug Mounjaro. A month later, Lilly went after 11 online pharmacies, including several overseas, that are allegedly importing, selling or distributing unauthorized versions of Mounjaro.
In May, in warning consumers about unauthorized versions of the weight loss drugs, the FDA explained that some pharmacies are permitted to make compounded versions of treatments that are having supply shortages. But in the rush to provide these highly demanded medications, some pharmacies are making versions with unauthorized ingredients.
As demand has increased for the weight loss drugs, sales have skyrocketed. In the third quarter, Lilly (38%) and Novo (29%) posted the largest year-over-year revenue increases in the industry. During the period, Ozempic and Wegovy combined for $4.7 billion in sales, which accounted for 57% of Novo’s revenue. Meanwhile, Mounjaro’s sales reached $1.4 billion in the quarter.