Did Novo open the Canadian market to GLP-1 generics?

In 2020, Novo Nordisk’s Canadian patent for semaglutide, the active ingredient in its blockbuster GLP-1 drugs Ozempic and Wegovy, quietly expired. The reason? A small missed maintenance fee, reportedly around  1,200 Canadian dollars. The lapse went largely unnoticed until it was recently highlighted by Derek Lowe in Science, where he described it as an eyebrow-raising moment for a company with so much at stake.

With no other semaglutide-related patents listed in Canada’s Patent Register, the path now appears clear for generic and biosimilar competitors to enter the market as early as January 2026. And this is what sparked Lowe’s attention as Sandoz’s chief executive officer (CEO), Richard Saynor, told Endpoint News that the company was planning to launch a GLP-1 generic in Canada as soon as governmental protection of semaglutide expires in 2026, because, according to him, Novo didn’t have the patent to protect it further.

For a drug projected to generate tens of billions in annual revenue globally, that kind of exposure, even in a single market, carries real consequences. The case raises broader questions about how companies manage intellectual property across jurisdictions, and what biotech firms of any size can learn from this slip.

GLP-1 patent expiration: Mistake or strategic decision from Novo Nordisk?

This raises the key question: Was the lapse a genuine oversight or a calculated move based on patent timelines?

On one hand, Steven Shape, partner and intellectual property (IP) Chair at Omnus Law, noted: “I am surprised that Novo did not pay the relatively insignificant maintenance fee to keep its issued Canadian patent alive… In Canada, the main protection for semaglutide is set to expire on January 4, 2026. This may have been the main impetus of Novo’s decision not to make the payment and allow the particular patent to lapse, likely not an oversight.”

In this view, letting the patent lapse might have simply been a low-cost calculation, especially if Novo believed their core IP protection was set to expire soon.

Shape confirmed this was likely not a mistake but a clear decision by Novo. “While oversights happen in IP services and third-party fee payment entities, oversights in fee payments are very rare… In this situation, it is more likely that the realization that this patent was expiring in January of 2026 and Novo was not giving up much by deciding not to pay this fee.”

To simplify, think of Novo’s drugs as being protected by two locks in Canada. The first is data exclusivity, a governmental rule that prevents anyone from even trying to copy the drug for eight years following the drug’s approval. This first lock started to be effective in 2018 and will naturally end in 2026. 

The second is the patent that Novo either overlooked or decided not to maintain. If maintained properly, this patent would have expired in March 2026, but it expired in 2020 instead.

At first glance, it looks like the patent was unnecessary since semaglutide was already protected by data exclusivity, and both were ending in early 2026. However, when data exclusivity ends, it ends for good, which isn’t necessarily the case for the patent. In many jurisdictions, including Canada, the protection of a patent can be extended by a certificate of supplementary protection (CSP). The extension granted by a valid CSP starts when the patent it is tied to expires, if it was adequately maintained.

What is surprising is that Novo did file a CSP for the semaglutide patent, and it was even granted by the Canadian authorities. It is still in the Canadian CSP register, scheduled to take effect in March 2026 and last until March 2028. 

But here’s the twist: the CSP is tied to the very patent Novo let expire in 2020, meaning the CSP would be invalid. “The CSP is only enforceable if the underlying patent is valid and in force at the time the CSP is set to take effect. If the patent lapses before the CSP’s start date, due to non-payment of maintenance fees or other reasons, the CSP cannot legally take effect or be enforced”, explained Shape

This is where the decision feels odd. Even if the decision wasn’t accidental, most large pharma companies wouldn’t let a patent lapse so quietly in Canada, one of Novo’s largest semaglutide markets, over a relatively small amount. Novo clearly saw some value in post-2026 protection; why else file the CSP? So, why abandon the underlying patent over a small fee?

If the CSP is invalid, it makes Novo’s decision not to maintain the patent questionable, to say the least, as it is losing two additional years of exclusivity on the Canadian market.

And according to Shape, the CSP is indeed as invalid as the Novo GLP-1 patent. “The Canadian CSP Register may list a CSP even if the underlying patent has lapsed, but this does not mean it is enforceable. Health Canada’s registers may not always be updated in real-time to reflect patent status changes.”

“If companies like Sandoz are not acting as if the CSP is enforceable, it is likely because they are aware the underlying patent has lapsed and thus the CSP is invalid. Novo’s decision not to maintain the patent indeed forfeits the additional two years of exclusivity the CSP would have provided had the patent remained in force,” said Shape

I reached out to Canada Health to confirm whether the CSP was invalid, but I am still waiting for an answer. In any case, 2026 will come very soon, and it will be very interesting to see how the situation unfolds. Will it be the beginning of a new IP war for Novo, like the one it is currently fighting on the Indian market?

What Novo Nordisk stands to lose in Canada and beyond

The expiry of Novo Nordisk’s semaglutide patent in Canada might look small on paper, but the consequences could be substantial. “There is no question that generic manufacturers are preparing for launch as soon as the Novo data exclusivity expires in January 2026. Once the protection expires, Novo Nordisk will lose its exclusive rights to sell semaglutide-based drugs in Canada, including Ozempic and Wegovy. This will open the market to generic and biosimilar competitors, likely driving prices down and increasing patient access,” said Shape.

As soon as January 2026, companies like Sandoz and Apotex are expected to launch generic versions of semaglutide in Canada, where protections from data exclusivity will come to an end. Sandoz has been especially vocal: its CEO Richard Saynor told Bloomberg the company would use Canada as a launchpad, citing the absence of a valid Novo GLP-1 patent as a clear green light.

The financial implications for Novo could be significant. “I am aware that analysts expect prices of Ozempic and Wegovy to drop by as much as 50 to 80% compared to the brand-name versions. Novo’s market shares will likely decline as healthcare providers and patients shift toward more affordable generic alternatives. Novo may focus on differentiating its products, such as with new formulations or combinations, but the core semaglutide market will face increased competition,” explained Shape.

For a drug that generates tens of billions annually, even partial loss of market share in a single country can be painful, and Canada happens to be Novo’s second-largest market for semaglutide. Once generics hit, public systems are likely to pivot quickly, switching patients to cheaper versions.

The situation may not stop at Canada’s borders. “These issues are not unique to Canada. Similar waves of generic filings are expected or already underway in other countries where semaglutide patents are expiring, such as China, India, and Brazil,” explained Shape.

However, Novo might have a few tricks up its sleeve, as its experimental obesity drug Amycretin could potentially surpass Wegovy and is set to start phase 3 trials in 2026.

Lesson learned from the Novo Nordisk IP case?

While we don’t know for sure if this GLP-1 patent lapse was a deliberate decision from Novo or a mistake, the case does shed light on the complexity of dealing with multiple jurisdictions. 

“Filing and maintaining patents in multiple countries is expensive. Fees for application, examination, grant, and annual maintenance can quickly add up, especially for companies with large portfolios. The administrative burden of tracking deadlines, fee payments, and compliance requirements across dozens or hundreds of patents is significant and requires robust intellectual property and document management systems,” said Shape.

For large firms, those systems exist, and yet even they can slip. For smaller biotech companies, the stakes are higher. A single missed deadline or unnecessary filing in a low-value jurisdiction can drain resources or create legal vulnerabilities.

So what’s the smarter path forward for leaner IP teams or biotechs with no IP teams at all?

According to Shape, key strategies for managing global IP maintenance costs include:

• Filing and maintaining rights only in jurisdictions where they offer a strategic or commercial advantage
• Regularly reassessing the value of each right and abandoning those that no longer align with business objectives
• Implementing a tiered maintenance strategy based on business importance
• Using analytics to assess market potential, competitor activity, and revenue impact
• Allowing rights to lapse in regions where they no longer provide value

The GLP-1 patent case may or may not reflect a costly mistake on Novo’s part, but it’s a reminder that IP isn’t static. For companies chasing global expansion or preparing for partnerships or acquisitions, clean, well-prioritized IP portfolios can make or break a deal. And in a world where even billion-dollar drugs can see their protection questioned over a missed fee, the lesson is clear: track and question everything.