Novo Nordisk secured a Dutch court injunction against an unapproved compounded semaglutide nasal spray, reinforcing patent rights and patient safety.
Written By: Amit Kumar Bharti, BPharm
Reviewed By: Pharmacally Editorial Team
Novo Nordisk has secured a preliminary injunction from the District Court of The Hague after a Dutch court ruled that a compounded semaglutide nasal spray sold by Ceban Ziekenhuisfarmacie B.V. infringed the company’s supplementary protection certificate (SPC) covering semaglutide. The ruling requires the company to immediately cease its infringing activities and reinforces Novo Nordisk’s efforts to protect its intellectual property and combat the distribution of unapproved compounded semaglutide products.
A supplementary protection certificate (SPC) is a form of intellectual property protection in Europe that extends patent rights for certain pharmaceutical products to compensate for time spent obtaining regulatory approval.
Court orders immediate halt to infringing activities
According to Novo Nordisk, the District Court of The Hague found that Ceban Ziekenhuisfarmacie B.V. had infringed Novo Nordisk’s SPC covering semaglutide by marketing a compounded nasal spray formulation. In addition to prohibiting further sales, the court ordered Ceban to remove references to the product from relevant websites and product listings, disclose information regarding its commercial supply chain, and reimburse Novo Nordisk’s legal costs.
Novo Nordisk said the judgment reinforces intellectual property protections while supporting regulatory frameworks designed to ensure medicines meet established standards of quality, safety, and efficacy.
Company emphasizes patient safety and regulatory oversight
Novo Nordisk stated that the injunction aims to protect patients from unapproved compounded semaglutide products, which have not been reviewed or approved by regulatory authorities such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA). The company noted that compounded medicines have not undergone the rigorous clinical development and regulatory review required for approved medicines to demonstrate their safety, efficacy, quality, or manufacturing consistency.
The company also reiterated that no semaglutide nasal spray has been approved by any regulatory authority and confirmed that it does not manufacture, distribute, or endorse any compounded semaglutide products.
Novo Nordisk reaffirms commitment to protecting innovation
John F. Kuckelman, Group General Counsel at Novo Nordisk, said the court’s decision sends a clear message that intellectual property rights protecting pharmaceutical innovation will be enforced. He added that the company will continue taking legal action against parties that unlawfully exploit its innovations or market unapproved semaglutide products in ways that could jeopardize patient safety and undermine the regulatory framework.
Novo Nordisk stated that protecting intellectual property remains essential to supporting continued investment in research and development while fostering future medical innovation. The company described the judgment as an important step in safeguarding its semaglutide-related intellectual property and maintaining the regulatory standards that support patient care.
Approved Novo Nordisk semaglutide medicines
Semaglutide, a GLP-1 receptor agonist discovered and developed by Novo Nordisk, is the active ingredient in four approved medicines:
- Wegovy® injection for chronic weight management.
- Oral Wegovy®, approved in certain markets for chronic weight management.
- Ozempic® for adults with type 2 diabetes and, in certain markets, to reduce the risk of major adverse cardiovascular events.
- Rybelsus® for the treatment of adults with type 2 diabetes.
Novo Nordisk reiterated that patients seeking semaglutide therapy should consult licensed healthcare professionals and use only medicines approved by their national regulatory authority.
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About the Writer
Amit Kumar Bharti (LinkedIn) is a pharmacy graduate from DPSRU, Delhi and healthcare writer with a strong interest in pharmaceutical research, medical writing, and evidence-based healthcare communication. He is passionate about translating complex scientific and medical information into clear, accurate, and engaging content for healthcare professionals and the pharmaceutical industry. His focus includes emerging therapies, clinical research, and recent advances in medicine.