Copycat Wegovy Products Undermining Sales, Novo Nordisk Warns of Legal Action

 

Krissy Vann | Host, All Things Fitness and Wellness

Novo Nordisk stated Thursday that the growth of the U.S. compounding pharmacy industry is affecting sales of its weight-loss drug Wegovy and said it is considering legal action against companies it believes are infringing on its intellectual property.

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

Compounding pharmacies in the United States have been producing copies of Wegovy and the related diabetes medication Ozempic, both based on the active ingredient semaglutide, under an emergency exemption permitted by the U.S. Food and Drug Administration (FDA) due to supply shortages. However, the FDA lifted its shortage designation for Wegovy last month, with pharmacies given a deadline of May 22 to cease compounded versions. A similar designation was removed for Eli Lilly’s Zepbound in December.

Jørgensen told shareholders that Novo Nordisk is escalating its response. “We are also taking legal actions against these compounders because we believe they are violating our IP and, as such, damaging our business,” he said.

Novo Nordisk has not named specific targets of potential litigation but signaled increased scrutiny of entities it believes are distributing unauthorized versions of its patented medications.

The company also made changes this week to its Wegovy savings program for cash-paying patients. Previously available only through the NovoCare Pharmacy, the $499-per-month price is now available at retail pharmacies for eligible individuals. This move appears aimed at expanding access to the FDA-approved version of the drug amid ongoing concerns over unregulated compounded alternatives.

According to the company, the revised program offers a 28-day supply of Wegovy for $499 to cash-paying patients or those with commercial insurance that does not cover anti-obesity drugs. The prior cost under the program was $650 per month. Patients covered by government-funded healthcare programs are not eligible.

Novo Nordisk did not connect the expanded pricing offer directly to its comments about compounded drugs. However, in a separate press release earlier this week, Dave Moore, Executive Vice President of U.S. Operations and Global Business Development, said the program would “help avoid the significant risks that can be posed by the compounding marketplace.”

Moore added: “With the evolution of our Wegovy savings program, we continue to deliver options that empower people living with obesity to more easily pursue their weight management and health goals.”

The FDA has issued multiple warnings over the past year about the risks of compounded semaglutide products, noting that these versions are not subject to the same regulatory scrutiny as approved drugs and may differ in dosage or formulation.

Novo Nordisk has faced persistent demand and intermittent supply challenges for Wegovy since its approval, with some U.S. healthcare providers and patients turning to compounding pharmacies as a stopgap. With FDA shortages officially lifted, the company’s stance signals a new phase in the ongoing tension between drug manufacturers and compounders operating under prior legal exemptions.

 
 

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