Health Canada Pausing Generic Semaglutide Reviews, Spokesperson Confirms

Regulator's Statement

In a March 25 email to The Globe and Mail, Health Canada spokesperson Marie-Pier Burelle said reviews may take longer when data is missing or additional data are required, and that during such pauses the time does not count toward the 180-day target [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. Burelle added that once new information is received, further review is required, and that the agency is on track to meet review targets for generic semaglutide drug submissions [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions].

Nine Applications Under Review

There are currently nine applications to make generic semaglutide sitting with Health Canada, some filed as early as February 2024 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. Three of those applications come from Ozempic generic challenger Apotex Inc., filed in January, April and November of 2025 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. Apotex spokesperson Catherine Thomas declined to comment on the company's Canadian applications [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions].

The CBC reports that Health Canada says nine generic semaglutide medications are under review, and that the agency's target timeline for initial review of a generic drug is 180 days [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339].

Academic Concern About Back-and-Forth

Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, said that, given the timelines, there appears to have been a lot of back-and-forth discussions between the regulator and drug manufacturers [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. Law said it is not clear yet if the delays are because of manufacturers taking too long to gather responses, or if Health Canada is requesting data that requires the companies to carry out new studies [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions].

The Globe and Mail previously reported that generic drugs were taking longer to be assessed by Health Canada, and that in most cases applications were being rejected just a few days before the deadline with a request for more information [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions].

Patent Status and First-Mover Stakes

Canada was the first major market where generic forms of semaglutide, the country's best-selling drug, became legal as of January 5 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. According to the Canadian Medical Association, Novo Nordisk's regulatory exclusivity for semaglutide ended on January 4, 2026 in Canada [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

Apotex on Friday announced it had won tentative approval from the U.S. Food and Drug Administration for a generic injectable form of semaglutide, developed with Indian pharmaceutical company Orbicular Pharmaceutical Technologies [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions]. The main U.S. patent on Ozempic, held by Novo Nordisk, expires in 2032 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions].

What Patients Are Watching

The CMA notes that Canadians may start seeing generic GLP-1 drugs around mid-2026, but not immediately, and that before any generic reaches a pharmacy, Health Canada must carefully review it to ensure it works the same way, is just as safe, and meets the same quality standards [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

Mina Tadrous, associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto, estimates generics might be available by this summer or early fall [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339].

• Track current branded prices for Wegovy, Mounjaro, Zepbound and Rybelsus.
• Follow the generic semaglutide tracker for filing-by-filing updates.
• Use the insurance coverage checker to review private and public plan rules.