Drug manufacturers in Canada will be allowed to produce lower-cost generic versions of Ozempic starting next week, but experts say patients should not expect the medication to reach pharmacies for several months.
As of Dec. 29, Health Canada had received nine submissions seeking approval to manufacture semaglutide, the active ingredient in the brand-name diabetes and weight-loss drugs Ozempic and Wegovy, both produced by Novo Nordisk.
“Health Canada understands that there is considerable interest in lowering costs associated with this highly prescribed drug by introducing generic versions,” said spokesperson Mark Johnson in an email to The Canadian Press.
According to Health Canada’s list of generic submissions, Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals, and Aspen Pharmacare Canada have all applied for authorization. Other applicants were not named because their submissions were filed before April 1, 2024, when Health Canada began requiring disclosure of sponsor names.
Sandoz Canada and Teva Canada said they could not comment on expected timelines for their products. The remaining companies did not respond to requests for comment.
Approval still months away
Mina Tadrous, a pharmaceutical policy expert at the University of Toronto, said generic semaglutide is unlikely to be approved before late spring or early summer.
“Canadians should not be expecting a product in January,” Tadrous said.
Health Canada’s target timeline for reviewing generic drug submissions is 180 days, Johnson said, though that clock can be extended if regulators request additional information from manufacturers.
Reviewing generic semaglutide is more complex than many other drugs because the original medication was developed using biological processes, while generic versions may be synthesized chemically.
“Generic semaglutide products are complex synthetic products that are pharmaceutically equivalent to the brand-name drug, but with possible differences that could impact safety and efficacy,” Johnson said. Manufacturers must demonstrate that any differences do not affect the drug’s quality, safety, or effectiveness.
Lower prices expected
Tadrous said generic pricing models suggest semaglutide could eventually cost as little as 35 per cent of the brand-name price, which currently runs several hundred dollars per month. Multiple generic manufacturers entering the market are expected to further drive down prices.
Dr. Ehud Ur, an endocrinologist in Vancouver, said access to generic semaglutide would be a major development for patients who currently cannot afford the medication.
“The biggest barrier to Ozempic is not side effects or doubts about effectiveness—it’s cost,” Ur said. “When you’re talking about two, three, four hundred dollars a month, that’s simply not possible for many people.”
Ur noted that while generic medications are expected to work the same as brand-name drugs, some patients may respond differently and choose to remain on the original version.
Patent expiry unique to Canada
Canada is the only country where Novo Nordisk allowed the patent on its semaglutide drugs to expire, bringing an end to regulatory exclusivity on Jan. 4 and opening the door to generic competition.
In a December interview with The Canadian Press, Vince Lamanna, president of Novo Nordisk Canada, declined to comment on details of the patent lapse but said more than one million Canadians currently use Ozempic or Wegovy.
“Irrespective of what happens in January or through 2026, we’re committed to supporting patients on semaglutide,” Lamanna said, adding that the company will continue to offer financial assistance to some patients without insurance coverage who choose to remain on brand-name products.
Competition remains limited
Novo Nordisk’s main competitor, Eli Lilly, still holds patent protection in Canada for its diabetes and weight-loss drugs Mounjaro and Zepbound, which contain the active ingredient tirzepatide.
Tirzepatide targets both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptors. Eli Lilly said it remains confident in the benefits of its dual-action drug but did not comment on whether it would offer price reductions to compete with generic semaglutide.
While generic Ozempic may still be months away, experts say its arrival could significantly improve affordability and access for Canadians living with Type 2 diabetes and obesity.