Novo Nordisk expands lawsuits in U.S. against weight-loss drug compounders

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Danish drugmaker Novo Nordisk NVO-N said on Tuesday it has filed 14 new lawsuits in the U.S. against the sale of unapproved versions of semaglutide, the main ingredient in its popular weight-loss and diabetes drugs, Wegovy and Ozempic.

The new lawsuits target companies producing compounded versions of semaglutide “under the fake guise of personalization,” Novo said.

Novo told Reuters its filing lawsuits against telehealth firms, compounding pharmacies and medical spas, including Prism Aesthetics, Mochi Health and Fella Health.

Some of these companies have also been named in Eli Lilly’s lawsuits, which accuse them of selling knockoff versions of tirzepatide, the active ingredient in Lilly’s weight loss drug Zepbound.

However, Novo has not filed a lawsuit against major telehealth firm Hims & Hers HIMS-N, which extended its losses nearly 11 per cent in afternoon trade after reporting weaker-than-expected quarterly revenue.

Compounders copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand.

These companies were temporarily allowed to produce compounded doses of Novo’s obesity and diabetes drugs when the Food and Drug Administration declared them in short supply.

When the agency later banned the sale of these copies, Hims and Hers shifted to creating versions of semaglutide in personalized doses not offered by branded manufacturers.

Novo’s lawsuits allege that telehealth providers violate state corporate practice of medicine laws by improperly influencing doctors’ decisions and steering patients toward knockoff compounded “semaglutide” under the guise of personalized medicine.

Novo said these are unapproved knockoffs, often made with illicit foreign active pharmaceutical ingredients (API), and have not been proven safe or effective.