FDA & regulation

Patent expert says Novo Nordisk could have extended its Canadian Ozempic patent to 2028

A patent expert says Novo Nordisk could have kept its Canadian Ozempic patent alive until 2028 but let it lapse, a mistake that helped make Canada the first G7 country with generic semaglutide.

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's Canadian patent covering semaglutide could have been extended to 2028 but was not renewed [1][2]. "Somebody dropped the ball … that's why you've got generics in Canada sooner," Amin said [2].

The patent lapsed after Novo Nordisk stopped paying a C$250 annual maintenance fee starting in 2018 [2]. A separate regulatory protection that blocks generic applications also expired, on January 5, 2026 [2]. Together, the two lapses cleared the way for generic makers to enter the Canadian market, making Canada the first G7 country to authorize a generic version of semaglutide [2].

Health Canada has since authorized two generic semaglutide injections, one from Dr Reddy's Laboratories and one from Apotex, with several more applications still under review [1][2]. Dr Reddy's product became available in Canadian pharmacies on May 15, 2026 [2]. Novo Nordisk has not explained why it stopped paying the fee. The company told the BBC the situation is "a localized situation based on our specific patent timelines and regulatory environment" that "does not reflect the situation in the United States, where exclusivity remains intact" [2]. Mina Tadrous, a pharmacist and drug policy researcher at the University of Toronto, told the BMJ the non-payment might have been "a strategy on their part," noting the decision predated semaglutide's full commercial boom [2]. Novo Nordisk earned roughly $29 billion from semaglutide products in 2024, including $17.5 billion from Ozempic alone [2].

Why it matters for patients

For patients in the United States, this development does not change what's available at the pharmacy counter right now. Novo Nordisk's U.S. patent protection for semaglutide remains intact until 2032, and protection in Europe and Japan runs until 2033 [2]. The Canadian lapse was tied to a specific fee and a Canada-only regulatory clock, not a broader legal weakness in Novo Nordisk's patent portfolio [2].

Still, the Canadian episode is a real-world example of how a single missed administrative step, a $250 annual fee, can open a market to lower-cost generic competition years earlier than expected [2]. Canadian pricing rules tie generic prices to how many competitors are on the market: one generic brings prices to about 75% of the brand price, two brings it to 50%, and three or more brings it down to 35% [2]. Tadrous estimated that once three generics are available, Canadian patients could pay around C$100 a month out of pocket [2]. Novo Nordisk has responded in Canada with brand-name discount cards and an ad campaign urging patients to ask for brand-name Ozempic, and Tadrous expects the company to keep more market share than is typical after a generic launch [2].

What happens next

Health Canada was still reviewing seven additional generic semaglutide applications as of the reporting [2]. Apotex had not yet announced a release date for its product [2]. Novo Nordisk has forecast that its 2026 global sales could fall between 5% and 13%, a sharp reversal after years of double-digit growth, and its share price dropped 17% on the day that guidance was announced [2]. The BMJ also reported that Eli Lilly's tirzepatide products, sold as Mounjaro and Zepbound, are projected to overtake semaglutide as the leading GLP-1 medications within the next few years [2]. Whether the Canadian patent lapse has any bearing on future U.S. pricing or exclusivity timelines is not addressed in the available reporting.

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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