Novo Nordisk says copycat compounders are hurting Wegovy sales, may take legal action

Copenhagen, DENMARK — Obesity drug giant Novo Nordisk said Thursday that the rampant growth of the U.S.’ compounded drug industry was hurting Wegovy sales, and warned it was considering legal action against companies it believes to be violating its intellectual property.

U.S. compounding pharmacies have been allowed to make legal copies of Novo’s Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, under a drug shortage ruling by the Food and Drug Administration.

The FDA last month declared the shortage over, however, giving compounding pharmacies until May 22 to cease selling copies of the drug. It follows the lifting of a similar shortage label on rival Eli Lilly’s Zepbound in December.

CEO Lars Fruergaard Jørgensen said that efforts to bolster supply of the wildly popular weight-loss drug had resulted in the drug’s removal from a drug shortage list.

“Given the significant growth of compounding in the U.S., it appears to impact Wegovy prescription uptake in 2025 so far,” Fruergaard Jørgensen told shareholders at the firm’s Annual General Meeting in Copenhagen, Denmark.

“We are also taking legal actions against these compounders because we believe they are violating our IP [intellectual property] and, as such, damaging our business,” he added.

The debate has sparked a legal battle between the two pharma giants and drug compounders trade group Outsourcing Facilities Association (OFA), which is seeking to retain rights to produce the lucrative drugs.

The OFA dubbed the FDA’s decision to declare the end of the shortage “reckless and arbitrary,” adding that it would “deprive patients of a vital treatment for type 2 diabetes, obesity, cardiovascular disease, and other serious medical conditions.” 

Demand for compounded obesity drugs, including from the likes of teleheath firm Hims & Hers, has ballooned amid the high costs and short-supply of branded treatments. Such products are not FDA approved, however, meaning the agency does not review them for safety, effectiveness or quality before they are marketed.   

Fruergaard Jørgensen said Thursday that Novo Nordisk analysis had detected “impurities and even banned products” in some compounded products, without naming any specific producers.

“This is not semaglutide,” he said, referring to compounded alternatives. “There’s only one semaglutide, and patients should really check the products before they inject them.”

It follows an FBI warning in February that counterfeit compounded weight loss drugs claiming to contain semaglutide had instead been found to include “compounded mixtures of unknown drugs that do not contain semaglutide, drugs with high levels of impurities, and unsafe or unapproved drugs.”

Fruergaard Jørgensen said he was optimistic that patients would return to branded Wegovy and Ozempic treatments as supply becomes increasingly available. Earlier this month, the Danish pharmaceutical firm launched a new direct-to-consumer online pharmacy offering Wegovy for less than half price in a bid to lure users back from cheaper compounded copycats.

“We have scaled supply so we are now off the FDA’s shortage list. I sincerely hope many of those patients will then come back to Novo Nordisk,” Fruergaard Jørgensen said.

Novo Nordisk has been seeking to reassure investors of its continued market lead amid increased competition and a series of disappointing obesity drugs trials that have battered the firm’s once sky-high share price.

Last month, the company reported better-than-expected net profit in the fourth quarter amid soaring demand for its Wegovy obesity drugs, but forecast a slight slowdown in sales for 2025.

Novo Nordisk shares closed down 3.8% Thursday following the AGM.