BMJ reporting traces Canada's generic semaglutide to an unpaid C$250 patent fee

Canada has become only the second country in the world to approve a generic version of semaglutide, the drug sold as Ozempic and Wegovy, after Novo Nordisk stopped paying a C$250 annual patent maintenance fee starting in 2018 ^[1][2]. Health Canada has authorized two generic injectable versions, one from India's Dr Reddy's Laboratories and one from Canadian manufacturer Apotex, with seven more applications still under review ^[1]. The Dr Reddy's product became available on May 15, 2026, while Apotex has not announced a release date ^[1].

Under Canada's Patent Act, once a maintenance fee lapses, the patent cannot be revived ^[2]. That lapse combined with a separate regulatory data-protection period that expired on January 5, 2026, and both had to happen before competitors could file generic submissions ^[2]. Tahir Amin, CEO of the Initiative for Medicines, Access & Knowledge, told the BBC that Novo Nordisk's Canadian patent could have run until 2028 had the fee been paid, saying "somebody dropped the ball" ^[2]. Mina Tadrous, a pharmacist and drug policy researcher at the University of Toronto, told the BMJ the non-payment may have been "a strategy on their part," noting it happened before semaglutide's commercial boom ^[2].

Novo Nordisk has not explained why the fee went unpaid. The company told the BMJ only that "all intellectual property decisions are carefully considered at the global level" ^[2]. It told the BBC the situation is "localized based on our specific patent timelines and regulatory environment and does not reflect the situation in the United States, where exclusivity remains intact" ^[2]. According to the reporting, Novo Nordisk's US semaglutide patent protection runs until 2032, and its European and Japanese protection runs until 2033 ^[2].

Canada's generic pricing follows a tiered framework: prices fall to 75% of the brand list price with one generic on the market, 50% with two, and 35% with three or more, according to Tadrous ^[2]. He estimated that once three generics are available, out-of-pocket costs in Canada could reach roughly C$100 a month ^[2]. Novo Nordisk earned about $29 billion globally from semaglutide products in 2024, including $17.5 billion from Ozempic alone, and the company has since launched brand-name discount cards and an advertising campaign in Canada urging patients to request brand-name Ozempic ^[2].

Why it matters for patients

For US patients, the direct practical effect is limited. Novo Nordisk has stated that US semaglutide patent exclusivity is intact, and the sources describe the Canadian generic approval as tied to a Canada-specific patent lapse and a Canadian data-protection expiration, not a US regulatory event ^[2]. That means people filling prescriptions for Ozempic, Wegovy, or Rybelsus in the United States are not expected to see generic semaglutide options domestically because of this development.

The Canadian episode is still relevant background for US readers because it shows how administrative details, in this case an unpaid C$250 fee, can shift a drug's competitive landscape years before patents would otherwise expire ^[1][2]. It also illustrates how quickly prices can move once generics enter a market: Canadian pricing rules tie discounts directly to the number of generic manufacturers, with costs potentially falling toward roughly C$100 a month once three or more generics are available ^[2]. Whether similar generic competition affects the US market depends on separate US patent timelines, which the sources describe as intact through 2032 ^[2].

What happens next

Seven additional generic semaglutide applications remain under Health Canada review, and it is not yet known when they might be approved or when Apotex's product will reach pharmacies ^[1]. Novo Nordisk has forecast that 2026 global sales could fall between 5% and 13%, which the company's CEO described as reflecting "a year of unprecedented pricing pressure," though the sources do not specify how much of that guidance is tied to the Canadian generics specifically ^[2].