The District Court of The Hague has granted Novo Nordisk a preliminary injunction against Ceban Ziekenhuisfarmacie B.V., ordering the Dutch company to immediately stop selling a compounded semaglutide nasal spray after finding that it infringed Novo Nordisk’s intellectual property rights.
Novo Nordisk said the ruling protects patients from unapproved formulations of semaglutide and reinforces the regulatory framework that ensures medicines meet established standards for quality, safety and efficacy.
The court found that Ceban infringed Novo Nordisk’s supplementary protection certificate for semaglutide and ordered it to cease the infringing activities. In addition, the company has been ordered to remove references to the product from relevant listings and websites, provide information regarding its commercial supply chain and reimburse Novo Nordisk’s legal costs.
“Protecting patients means protecting the integrity of the medicines they rely on,” said John F. Kuckelman, Group General Counsel, Novo Nordisk.
“This decision sends a clear message that intellectual property rights protecting pharmaceutical innovation will be enforced. We will continue to take decisive legal action against those who unlawfully exploit our innovations or market unapproved semaglutide products in ways that jeopardise patient safety and undermine the regulatory framework that protects patients,” he added.
Novo Nordisk noted that compounded medicines are pharmacy-prepared formulations that are not reviewed or approved by regulatory authorities such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). Unlike approved medicines, they do not undergo the clinical trials required to demonstrate safety, efficacy, quality, or consistent manufacturing standards.
The company also emphasised that it does not manufacture, distribute or endorse any compounded version of semaglutide and that no nasal spray formulation of semaglutide has been approved by any regulatory authority.
According to Novo Nordisk, its approved semaglutide medicines include Wegovy, Ozempic and Rybelsus. Wegovy (available in oral and injectable formulations in approved markets) is approved for chronic weight management in eligible adults, while Ozempic (semaglutide injection 1.0 mg) and Rybelsus (oral semaglutide 14 mg) are approved for the treatment of adults with type 2 diabetes.
