Novo Nordisk (NYSE: NVO) has permanently forfeited Canadian patent protection for semaglutide—the blockbuster active ingredient in Ozempic and Wegovy—after failing to pay a routine $450 maintenance invoice in 2019.
Under Canada’s Patent Act, once a missed-fee grace period lapses, rights “cannot be revived,” formally clearing the way for rival filings.
Canadian maintenance charges start at $100 in year 3 and ratchet up annually. Novo last paid in 2018, then asked for a refund of its 2017 remittance “to buy time” before ultimately letting the patent die.
Ozempic alone generated around US$14 billion in global sales last year, roughly $2.5 billion of that in Canada—making it the nation’s top-selling drug. Analysts peg the Canadian GLP-1 receptor-agonist market at US$1.18 billion in 2023, set to compound 23 % annually to more than US$5 billion by 2030, with Ozempic capturing the lion’s share.
Because biologics enjoy eight years of data exclusivity in Canada, generic applications cannot obtain a Notice of Compliance until January 2026—exactly eight years after Ozempic’s approval on January 2018. Sandoz, Hikma Pharmaceuticals, and Aspen Pharmacare have all confirmed semaglutide dossiers “ready to go,” with Sandoz publicly targeting a Canadian launch once the clock hits zero.
Novo’s US patents run until at least 2032, yet Florida and several other states have Section 804 drug-import plans on the FDA’s desk. A validated Canadian biosimilar supply line could hand import advocates their best test case, dragging semaglutide prices southward well before Wall Street spreadsheets predict.
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