Novo Nordisk Loses Semaglutide Patent In Canada Due To Unpaid Fee

Novo Nordisk, a prominent pharmaceutical company, has lost its patent protection for semaglutide, the active ingredient in its widely used diabetes and weight loss medications Ozempic and Wegovy, in Canada. This loss of protection is due to the company's failure to pay a nominal maintenance fee of 450 Canadian dollars. The expiration of the patent allows generic versions of semaglutide to be produced and sold in Canada, potentially increasing competition and reducing Novo Nordisk's market share for its branded products.

Years before semaglutide became a blockbuster drug for Novo Nordisk, the company had the opportunity to maintain its patent in Canada but did not pay the required fee. The drug, sold as Ozempic and Wegovy, has generated billions of dollars in revenue for Novo Nordisk, significantly impacting Denmark’s economy. To keep the semaglutide patent in Canada, the company was required to pay an annual fee of 250 Canadian dollars. While Novo Nordisk paid this amount in 2018, it failed to do so the following year. The Canadian government offered Novo Nordisk another chance to retain its patent, this time with an additional charge that brought the total to 450 Canadian dollars. However, the company did not take advantage of this opportunity, leading to the lapse of the patent.

The loss of patent protection is a significant setback for Novo Nordisk, as semaglutide is a crucial component of its diabetes and weight loss drug portfolio. The company has invested heavily in the development and marketing of these drugs, and the loss of patent protection could impact its revenue and market position. However, it is important to note that the loss of patent protection in Canada does not necessarily mean that Novo Nordisk will lose its market share in other regions, as patent protections and regulatory environments vary by country.

Makers of generic drugs have taken notice of the situation. Sandoz, a company that produces generic drugs, has filed to launch a generic GLP-1 in Canada next year and expects approval sometime in the first quarter when exclusivity expires. The CEO of Sandoz, Richard Saynor, commented on the situation, stating that it is an interesting market and that Novo Nordisk never filed a patent in Canada. He also noted that Canada is the second-largest semaglutide market in the world.

In a statement, Novo Nordisk said there was no mistake regarding its patent maintenance fee in Canada and declined to comment on other drug manufacturers’ plans. The company added that all intellectual property decisions are carefully considered at a global level and that periods of exclusivity for pharmaceutical products end as part of their normal lifecycle, allowing generic treatments to become available over time. The company confirmed that protection for semaglutide regulatory submissions in Canada will expire in 2026. Meanwhile, Ozempic patents expire several years later in other major markets, such as the U.S. (2032), Japan (2031), and Europe (2031).

Last year, Novo Nordisk generated about $19 billion in global Ozempic sales and about $9 billion in Wegovy sales. In Canada, retail pharmacies booked Ozempic sales of 2.5 billion Canadian dollars. The situation highlights the importance of compliance with regulatory requirements and the potential consequences of failing to do so. Companies must ensure that they are aware of and comply with all relevant regulations and fees in the countries where they operate, as failure to do so can result in significant financial and reputational damage. In this case, the loss of patent protection for semaglutide in Canada serves as a reminder of the importance of regulatory compliance and the potential risks associated with non-compliance.