Novo Nordisk's Canadian data exclusivity on semaglutide expires

Novo Nordisk's data exclusivity for semaglutide in Canada expired on January 4, 2026, removing the last regulatory barrier to generic copies of Ozempic in that country ^[3]. Because Novo's core Canadian compound patent had already lapsed years earlier over an unpaid maintenance fee, the expiry left Canada open to generic semaglutide well before the United States ^[2][3].

The patent story is unusual. Canadian patent CA 2,601,784, covering "acylated GLP-1 compounds," lapsed after Novo Nordisk did not pay a CAD $250 maintenance fee in 2019 ^[4]. The Canadian Patents Database shows the last maintenance-fee payment was received October 23, 2018, and that the window to reverse the lapse closed August 31, 2020 ^[4]. With the late fee, reinstatement would have cost CAD $450, roughly $339 USD ^[4]. Canada's certificate of supplementary protection register lists a March 20, 2026 patent expiry that could have been extended to March 20, 2028 ^[4]. Novo Nordisk has said the lapse was a deliberate strategic decision rather than an error ^[3][4].

Because the compound patent is no longer on Canada's Patent Register, generic applicants are not subject to the usual linkage litigation under the Patented Medicines (Notice of Compliance) Regulations, including the typical 24-month stay on approvals ^[3]. That streamlined the path once data protection ran out.

What followed in Canada

In mid-January 2026, Health Canada had nine generic semaglutide applications under review ^[2]. Sandoz, which had aimed to launch in the first half of 2026, said it expected the Canadian generic market to take shape in the third quarter after it and Dr. Reddy's Laboratories were told to supply more data ^[2]. Sandoz had earlier committed to pricing up to 70% below the brand, which would cut a monthly cost of about CAD 1,000 to CAD 300 or less ^[3].

Health Canada authorized Dr. Reddy's generic semaglutide injection on April 28, 2026, making Canada the first G7 country to approve a generic version ^[4]. Apotex's generic Ozempic followed on May 1, with seven more submissions still under review ^[1][4]. Health Canada described the products as complex synthetic drugs that are pharmaceutically equivalent to the brand and said its review confirmed the differences do not affect safety, efficacy or quality ^[1]. The approvals cover once-weekly treatment of adults with type 2 diabetes ^[1]. Dr. Reddy's authorization covers 2 mg/pen and 4 mg/pen presentations at 1.34 mg/mL ^[4].

The stakes in Canada are large: Ozempic was the country's best-selling drug with $2.9 billion in 2025 sales, and more than a million Canadians use it ^[4]. Under Canadian pricing policy, once three generic competitors are on the market, list prices fall about 65% ^[2]. Health Canada says generics there are often 45% to 90% cheaper than brands ^[1].

Why it matters for patients

None of this changes US availability or pricing directly. Novo Nordisk's 2025 Form 20-F lists US compound patent expiry for Ozempic, Rybelsus and Wegovy as 2032, and 2031 in Japan and Europe ^[4]. Several manufacturers have filed US abbreviated new drug applications with Paragraph IV certifications, and Novo settled Ozempic patent litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy's, Mylan, Zydus and Apotex on confidential terms — so US generic timing is not public ^[4].

Canada is being watched as an early test of what generic pricing does to access, with possible spillover through US importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act ^[3]. IQVIA has also warned that as more manufacturers enter, "the dangers of counterfeiting and substandard quality are likely to be multiplied" ^[2].

What happens next

Health Canada says it expects decisions on more of the seven pending submissions "in the coming weeks and months" ^[1]. Sandoz points to the third quarter of 2026 for the Canadian generic market to take shape ^[2]. Whether and when any US generic launches remains unknown from these sources.