Regulation

Patent expert says Novo Nordisk let an Ozempic patent extension lapse in Canada

A patent expert says Novo Nordisk could have kept its Canadian Ozempic patent alive until 2028 but let it lapse, opening Canada to generic semaglutide while US exclusivity runs to 2032.

By the Semaglutides news desk··Ozempic
The $250 Fee: How a Lapsed Patent Opened Canada's Generic Market
Image: glp1prices.ca

Tahir Amin, chief executive of the Initiative for Medicines, Access & Knowledge, told the BBC that Novo Nordisk held a Canadian patent on semaglutide, the molecule in Ozempic, Wegovy and Rybelsus, that could have run until 2028, and did not renew it [2]. In his words, "Somebody dropped the ball … that's why you've got generics in Canada sooner" [2].

Canada went on to become the first Group of Seven country to authorize a generic version of the drug [2]. Two events had to line up before competitors could file: the patent lapsed after Novo Nordisk stopped paying a C$250 annual maintenance fee beginning in 2018, and a separate regulatory approval requirement ran out on January 5, 2026 [2].

Health Canada has cleared generic semaglutide injections from Dr Reddy's Laboratories, based in India, and from the Canadian manufacturer Apotex [2]. The Dr Reddy's product reached the Canadian market on May 15, 2026; Apotex has not said when its version will ship [2]. Published counts differ. A notice on one Canadian price-tracking site says three of nine generic semaglutide products have been approved by Health Canada [1], while an article on the same site counts two authorizations with seven more applications still under review [2].

Novo Nordisk has not said publicly why the maintenance fee went unpaid. The company told The BMJ that "all intellectual property decisions are carefully considered at the global level" [2]. Mina Tadrous, a pharmacist and drug policy researcher at the University of Toronto, told The BMJ the missed payment may have been "a strategy on their part," noting it came before semaglutide's commercial boom [2]. Novo Nordisk took in about US$29 billion from semaglutide products in 2024, $17.5 billion of it from Ozempic alone [2].

Novo Nordisk's public position is that Canada is "a localized situation based on our specific patent timelines and regulatory environment and does not reflect the situation in the United States, where exclusivity remains intact" [2]. The company is offering discount cards for its brand-name product and running Canadian advertising that urges patients to ask for brand-name Ozempic [2].

Why it matters for patients

For anyone filling a prescription in the United States, the Canadian patent outcome does not change what is on the shelf. According to The BMJ, semaglutide exclusivity in the US runs to 2032, and to 2033 in Europe and Japan [2]. Whether cheaper Canadian generics influence US list prices, insurer coverage or supply has not been reported.

Canada is the first G7 market where generic competition is testing what happens to GLP-1 prices. Tadrous told CBC News that Canadian prices step down as competitors arrive: 75% of the brand list price with one generic, 50% with two, and 35% with three or more [2]. He estimated to The BMJ that once three generics are selling, patients paying cash could be looking at roughly C$100 a month [2]. Pharmacy prices tracked by GLP1Prices.ca currently list brand Ozempic from $86.40 to $663 CAD and Wegovy from $270 to $550 CAD [2]. A separate page on that site describes a pCPA framework that sets the first generic at 75% to 85% of brand and drops to 35% once three or more are on the market [1].

Eli Lilly's tirzepatide brands, Mounjaro and Zepbound, are projected to pass semaglutide as the leading GLP-1 products within a few years, per The BMJ [2].

Novo Nordisk has said it expects 2026 sales to fall between 5% and 13%, its first such decline after years of double-digit growth [2]. Its share price dropped 17% on the day it gave that guidance, and chief executive Mike Doustdar called 2026 "a year of unprecedented pricing pressure" [2].

What happens next

Seven more generic semaglutide applications are pending at Health Canada, and Apotex has not announced a release date for its authorized product [2]. The next pricing step in Canada is expected when a third generic reaches the market [1][2]. Outside Canada, the exclusivity dates that matter are 2032 in the United States and 2033 in Europe and Japan [2].

Sources

  1. https://glp1prices.ca/glp1-news
  2. https://glp1prices.ca/glp1-news/novo-nordisk-250-dollar-patent-fee-lapse-canada-generics-september-2026

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