Generic Semaglutide Filing Dates: How Long Apps Have Waited

Health Canada is reviewing nine generic semaglutide submissions, with the oldest pending applications dating back to February 2024 — more than two years before the regulator has issued any approval [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

What the public tracker shows

Health Canada's Submissions Under Review list discloses generic submissions that have been accepted for review, but the regulator does not confirm exact filing dates publicly for every product [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498]. According to The Globe and Mail, nine applications to make generic semaglutide are currently 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/].

Apotex filed three separate submissions

Three of the nine pending applications come from Apotex, 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 company has not disclosed how the three filings differ from each other, or whether any are tied to its U.S. partnership with Orbicular Pharmaceutical Technologies, which produced the version that won tentative FDA approval [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Other applicants in the queue

According to GLP1Prices.ca's generic semaglutide tracker, seven submissions have been confirmed under Health Canada review from five companies as of January 2026: Sandoz Canada, Apotex (three separate submissions), Taro Pharmaceuticals, Aspen Pharmacare, and Teva Canada [Source: glp1prices.ca/generic-alert]. PharmaTher announced on February 2, 2026 a strategic initiative to pursue Health Canada approval for generic semaglutide, targeting broad dose coverage from 0.25 mg to 2.4 mg [Source: glp1prices.ca/generic-alert].

The 180-day target and clock-stopping

Health Canada has a target of 180 days to assess generic drug applications [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Spokesperson Marie-Pier Burelle wrote in a March 25 e-mail that reviews may take longer if data is missing or additional data are required, and that when this happens, Health Canada pauses its review while awaiting additional information from the manufacturer — time that does not count toward the 180-day target [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Burelle stated that, to date, Health Canada 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/].

Why generic semaglutide reviews are complex

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

Brand-name strategy in the meantime

Canada was the first major market where generic forms of semaglutide became legal as of January 5 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Ahead of that date, Health Canada approved Plosbrio and Poviztra on December 22, 2025 — Novo Nordisk's lower-cost rebrands of Ozempic and Wegovy, respectively — as a strategy to compete with upcoming generics [Source: glp1prices.ca/generic-alert]. Novo Nordisk also continues to sell Rybelsus, an oral semaglutide pill approved by Health Canada [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498]. Eli Lilly's tirzepatide products, Mounjaro and Zepbound, are not affected by the semaglutide patent expiry.

What's next

The earliest Health Canada decisions on generic semaglutide approvals are expected in Q3 2026, per Sandoz and industry estimates, though Health Canada's review backlog may extend timelines [Source: glp1prices.ca/generic-alert]. Patients tracking availability can monitor our generic semaglutide tracker, check the insurance coverage checker, or visit our FAQ for more information.

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