Oops-zempic? Novo Nordisk opens the door to early Ozempic generics in Canada

It has emerged that Novo Nordisk missed the payment of the maintenance (renewal) fee on their Canadian Ozempic patent, resulting in its irrevocable lapse in 2020. The missed maintenance fee of ~$250 CAD quietly clears the way for earlier-than-expected generic competition in Canada, a top five market for the high-demand weight-loss and diabetes drug. 

Ozempic (also marketed under the brand names Rybelsus and Wegovy) is the brand name for semaglutide, a GLP-1 receptor agonist. Originally prescribed for the treatment of type 2 diabetes, Ozempic has surged in popularity as a weight-loss drug following viral attention on social media. 

There has been speculation whether the missed maintenance fee was a strategic decision or a mistake on the part of Novo Nordisk. 

Novo Nordisk enjoyed marketing Ozempic exclusively in Canada due to two mechanisms. The first, a Canadian patent set to expire in March 2028 (inclusive of the patent Certificate of Supplementary Protection term). The second, an 8-year term of regulatory exclusivity, which is due to expire in January 2026.

While the patent would have extended the term of protection by two years, it brought Ozempic under the jurisdiction of the Canadian Patented Medicine Prices Review Board (PMPRB). This independent board has the authority to review and potentially lower the price of patented medicines to ensure the prices are not excessive. This invites the question - did Novo Nordisk miss the maintenance fee in error or did they intentionally abandon the patent to avoid Ozempic price regulation under the PMPRB and maintain a higher market price during the exclusivity period? Although relinquishing the patent would allow generics to enter the market sooner (i.e., after regulatory exclusivity ends in 2026), it may have been seen as a worthwhile trade-off for preserving premium pricing in the meantime. 

Presently, the rationale behind the lapse remains unknown. However, the patent lapse does certainly provide an opportunity for generic companies to access the substantial and growing Canadian Ozempic market earlier than anticipated. Indeed, one estimate values the Canadian semaglutide market at $1.18 billion USD in 2024 with an annual growth rate of 22.9% (Grand View Research, Canada Semaglutamide Size & Outlook, 2024-2035). Although no generic companies have received marketing approval for a generic version of Ozempic, we anticipate that they will move quickly to submit their applications to Health Canada once the exclusivity period ends in January 2026.

Looking beyond Canada, this development could also impact Novo Nordisk's position in the U.S. market. Once the U.S. patent expires in 2032 (assuming all maintenance fees are paid), we foresee that generic companies will be well-positioned to enter the U.S. market immediately upon patent expiration. 

While we don’t know for certain if the Ozempic patent lapse was a costly oversight or a deliberate decision from Novo Nordisk, the case provides a good reminder to always use a robust and reliable service provider for managing patent maintenance fees to ensure the full potential of your intellectual property is realized.