Novo Nordisk Sues Over Generic Wegovy, Citing Safety Concerns

Novo Nordisk, a prominent pharmaceutical company, has announced its intention to take legal action against companies that it alleges are infringing on its intellectual property rights related to its flagship product, Wegovy. The company has cited the impact of compounding pharmacies, which have been allowed to produce generic versions of Wegovy and Ozempic due to drug shortages, as a significant factor in the decline of its sales.

The U.S. Food and Drug Administration (FDA) had previously permitted compounding pharmacies to produce these generic versions to address the shortages. However, with the shortages now resolved, the FDA has mandated that these pharmacies cease production. Novo Nordisk has expressed concern that these compounded versions are not equivalent to the original product, potentially compromising patient safety and efficacy.

Novo Nordisk's CEO, Lars Fruergaard Jørgensen, emphasized that the true version of semaglutide, the active ingredient in Wegovy, is unique and that patients should be aware of the differences between the original product and the compounded versions. He stated that the company is taking legal action against these compounding manufacturers because they believe their intellectual property has been infringed upon, which has negatively impacted their business.

This dispute has sparked a legal battle between the two pharmaceutical giants and the compounding pharmacy industry organization, the Outsourcing Facilities Association (OFA). The OFA is attempting to retain the right to produce these profitable drugs. The OFA has criticized the FDA's decision to end the drug shortage designation as "reckless and arbitrary," claiming that it will "deprive patients of key treatment options for type 2 diabetes, obesity, cardiovascular disease, and other serious conditions."

In response to the high cost and limited supply of branded drugs, there has been a surge in demand for compounded weight loss medications, including from remote healthcare providers such as Hims & Hers. However, these products have not been approved by the FDA, meaning that their safety, efficacy, and quality have not been reviewed before they hit the market.

Jørgensen revealed that Novo Nordisk's analysis has found that some compounded products contain "impurities and even illegal ingredients," although he did not name specific manufacturers. He advised patients to carefully check the product before injecting it, stating that "this is not the real semaglutide. The real semaglutide has only one form, and patients should really check the product before injecting it."

Earlier this year, the FBI issued a warning about counterfeit compounded weight loss medications containing semaglutide, stating that they are "mixtures of unknown composition that do not contain semaglutide and contain high levels of impurities as well as unsafe or unapproved drugs."

Jørgensen expressed optimism that as supplies become more abundant, patients will return to using the branded drugs Wegovy and Ozempic. Earlier this month, the Danish pharmaceutical company launched an online pharmacy aimed directly at consumers, offering Wegovy at less than half its original price to attract users back to the genuine product.

Novo Nordisk has been working to reassure investors of its market leadership position amid intense competition and a series of disappointing weight loss drug trials that have impacted its once-high stock price. Last month, the company reported better-than-expected fourth-quarter net profits due to surging demand for Wegovy, but also forecasted a slight slowdown in sales for 2025.