Canada approves generic semaglutide after Novo Nordisk lets a C$250 patent fee lapse
Canadian pharmacies now have generic semaglutide because of an unpaid C$250 fee, but Novo Nordisk says US exclusivity lasts until 2032, so American patients are unlikely to see a generic soon.
Canada has approved two generic versions of injectable semaglutide, the medicine sold there as Ozempic, after Novo Nordisk stopped paying a C$250 annual patent maintenance fee beginning in 2018, according to reporting by The BMJ [1][2].
Health Canada cleared the products from Dr Reddy's Laboratories, based in India, and Apotex, a Canadian manufacturer [1]. Dr Reddy's began selling its version on 15 May 2026; Apotex has not announced a release date [1][2]. Seven more generic applications are still being reviewed [1][2]. The BMJ, which published its account on 19 May 2026, called Canada only the second country in the world to authorise a generic form of the drug [1]. GLP1Prices.ca described it as the first G7 nation to do so [2].
"As the first company to receive market authorisation for generic semaglutide injection in Canada, we remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes in the country," Dr Reddy's chief executive Erez Israeli said in a press release [1].
Two separate events had to line up before competitors could file, GLP1Prices.ca reported: the patent lapsed once the annual fee went unpaid, which under Canada's Patent Act cannot be undone, and a data protection requirement ran out on 5 January 2026 [2].
Novo Nordisk has not explained the missed payment. The company told The BMJ only 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 choice may have been "a strategy on their part," made before semaglutide became a blockbuster [2]. Tahir Amin, chief executive of the Initiative for Medicines, Access & Knowledge, told the BBC the Canadian patent could have run until 2028 had it been kept up. "Somebody dropped the ball … that's why you've got generics in Canada sooner," he said [2].
Novo Nordisk took in about US$29bn from semaglutide products in 2024, $17.5bn of it from Ozempic [2]. The company told the BBC that what happened in 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]. Novo Nordisk holds semaglutide patent protection in the US until 2032 and in Europe and Japan until 2033 [2].
Why it matters for patients
Americans should not expect a generic semaglutide any time soon. Novo Nordisk says its US exclusivity is intact through 2032, and nothing reported indicates that Canadian generics can be shipped into or sold in this country [2].
Inside Canada, the price picture depends on how many manufacturers compete. Tadrous told CBC News that one generic brings prices to 75% of the brand list price, two brings 50%, and three or more brings 35% [2]. He estimated to The BMJ that once three are available, patients paying cash should reach roughly C$100 a month [2]. Canadian pharmacy listings tracked by GLP1Prices.ca currently show brand Ozempic at C$86.40 to C$663 and Wegovy at C$270 to C$550 [2]. Those are Canadian figures and do not reflect US prices.
Novo Nordisk is pushing back with discount cards and an advertising campaign in Canada that asks patients to request brand-name Ozempic [2]. Tadrous told The BMJ he expects the brand to hold more market share than is usual after generics arrive [2].
What is still unknown: how the fee was overlooked, and whether maintenance fees on Novo Nordisk's other patents are current. That has not been reported [1][2].
What happens next
No decision dates have been set for the seven generic applications still with Health Canada, and Apotex has not said when its product will ship [1][2]. The steepest Canadian price tier requires at least three competitors on the market [2].
Novo Nordisk has separately forecast that 2026 sales will drop between 5% and 13%, ending years of double-digit growth; the shares fell 17% the day that guidance came out, and chief executive Mike Doustdar called 2026 "a year of unprecedented pricing pressure" [2]. The BMJ also reported that Eli Lilly's tirzepatide brands, Mounjaro and Zepbound, are expected to overtake semaglutide as the leading GLP-1 products within a few years [2].
Sources
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