Novo Nordisk, the Danish pharmaceutical giant behind the blockbuster diabetes and weight loss drugs Ozempic and Wegovy, has lost its patent protection for semaglutide in Canada after failing to pay a maintenance fee. The oversight comes as the company faces increasing competition from generic drugmakers, including Sandoz, which plans to launch its own version of the medication in early 2026. The loss of patent protection in Canada, a key market for the drug, could have significant financial implications for Novo Nordisk as it navigates the shift to a more competitive landscape in the diabetes and weight loss therapy space.
The patent lapse was triggered by the company’s failure to pay a $450 maintenance fee for the semaglutide patent in 2019. Despite having a one-year grace period after the fee became due, Novo Nordisk did not make the payment. Canadian patent authorities confirmed that the patent cannot be revived once it has lapsed, leaving the company with no legal protection for the drug in the country. The decision highlights the importance of patent maintenance in the pharmaceutical industry and underscores the financial risks associated with regulatory compliance.
Canada represents the world’s second-largest market for semaglutide, with annual sales in the billions of dollars. The loss of patent protection means that generic manufacturers, such as Sandoz, can now enter the market and compete with Novo Nordisk’s brand-name drugs. While the company still holds U.S. patent protection for semaglutide until at least 2032, the loss in Canada marks a significant setback for its market dominance. Novo Nordisk will now have to contend with lower prices and potential loss of market share in one of its most important markets.
The incident also raises questions about the broader implications for the pharmaceutical industry. As companies face increasingly complex regulatory requirements and higher costs associated with maintaining patent protections, the risk of losing critical market advantages grows. This situation may prompt other pharmaceutical firms to be more vigilant in their compliance strategies. Additionally, it is expected that the entry of generic versions of semaglutide will impact both Novo Nordisk and patients, potentially reducing the cost of these medications in the long run.