Oldest Generic Semaglutide Filing Dates to February 2024

Health Canada is working through nine generic semaglutide applications, some filed as early as February 2024, more than two years before any decision has been issued [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Nine pending files, multiple applicants

The regulator currently has nine applications to make generic semaglutide, the active ingredient in Novo Nordisk's Ozempic and Wegovy, according to a count published by The Globe and Mail [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. CBC News reported the same nine-submission tally, citing the Submissions Under Review list maintained by Health Canada [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498].

Three of those filings belong to Canada's largest drug manufacturer, Apotex Inc., which submitted applications 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 how those three Canadian applications differ from one another or whether any of them involve the company's Indian partner Orbicular Pharmaceutical Technologies [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

The 180-day target versus the calendar

Health Canada's stated assessment target for generic drug applications is 180 days [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. With the earliest semaglutide file dating to February 2024, the elapsed calendar time now exceeds that target by a wide margin, although the regulator has said it pauses the clock when additional data are required.

In a March 25 email, Health Canada spokesperson Marie-Pier Burelle wrote that reviews may take longer if data is missing, and that paused 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 to date, Health Canada is on track to meet review targets for generic semaglutide submissions [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Another Health Canada spokesperson, Mark Johnson, told CBC that evaluating generic semaglutide is more complex than many other medication approvals because semaglutide was originally developed using biological processes, while the generic versions can be made using simpler chemical means [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498].

Why the filing dates matter

Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, said the timelines suggest significant back-and-forth 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 whether delays stem from manufacturers taking time to respond or from Health Canada requesting data that requires new studies [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Mina Tadrous, an associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto, told CBC he does not expect cheaper versions to be approved in January or February, suggesting summer would be more likely [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498]. The Canadian Medical Association has told patients they may start seeing generic GLP-1 drugs in Canada around mid-2026 [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

Context on exclusivity and applicants

Novo Nordisk's regulatory exclusivity for semaglutide ended January 4, 2026, in Canada, making the country the first major market where generic forms of semaglutide became legal [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada][Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Companies with pending Canadian applications include Apotex, and two unnamed drug makers that also received regulatory approval to sell generic semaglutide in India on March 23 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Health Canada publishes its queue on the Submissions Under Review list [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html]. Patients tracking availability can follow our generic semaglutide tracker or check coverage details through the insurance coverage checker. Branded comparators remain the only options in Canadian pharmacies today, including Rybelsus and tirzepatide-based Mounjaro.

What to watch

• Whether Health Canada issues its first Notice of Compliance for a generic semaglutide product this summer, consistent with expert projections [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498].
• Whether Apotex discloses how its three 2025 Canadian filings relate to its Orbicular partnership [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].
• Updates on the Submissions Under Review list maintained by Health Canada [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html].

This article is for informational purposes only and does not constitute medical advice.