Novo Nordisk filed suit against another semaglutide compounder on Friday, bringing its total number of cases to 50.
Both Novo Nordisk and Eli Lilly have launched legal campaigns against medical spas, weight loss clinics and compounding pharmacies marketing their own versions of blockbuster weight loss and diabetes drugs. In a win for compounders last week, the FDA said it will reconsider removing Lilly’s tirzepatide from its national shortage list, reopening the door for some compounders to sell their own copies while the agency assesses.
Compounding is allowed when a drug needs to be altered in some way to meet the needs of a patient, or in certain circumstances when there is a shortage. Novo continues to experience “limited availability” for one dose of its weight loss drug Wegovy, according to the FDA’s shortage database. But the company continues to fight compounders in court, alleging that deceptive marketing may lead some patients to believe the compounded products are FDA-approved, or that they are authentic Novo products.
In September and October alone, Novo Nordisk filed 18 new lawsuits against compounders. The latest suit targets Advanced Vitality HRT, a Cincinnati-based medical clinic. Advanced Vitality was not available for immediate comment.
“As the FDA has cautioned, unapproved compounded ‘semaglutide’ drugs do not have the same safety, quality, and effectiveness assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded drug if an approved drug is available,” a Novo Nordisk spokesperson told Endpoints News on Monday.
The company added that increases in the use of compounded semaglutide products have been followed by an uptick in adverse event reports. The spokesperson said Novo will “continue to pursue legal action against other entities engaged in similar conduct.”