Apotex Has Three Separate Generic Semaglutide Filings in Canada

Canadian generic drug giant Apotex Inc. has three separate generic semaglutide applications sitting with Health Canada, filed in January, April and November of 2025, The Globe and Mail reported. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Three filings, undisclosed differences

Apotex spokesperson Catherine Thomas declined to comment on how the company's three Canadian applications differ from one another, or whether any of them are filed in partnership with Indian pharmaceutical company Orbicular Pharmaceutical Technologies, the partner on Apotex's U.S. submission. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

The disclosure comes alongside news that Apotex won tentative approval from the U.S. Food and Drug Administration for a generic injectable form of semaglutide — the active ingredient in Ozempic, Wegovy and Rybelsus — six years before the U.S. patent expires. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Nine applications in the Canadian queue

Health Canada currently has nine generic semaglutide applications under review, some filed as early as February 2024. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/] The regulator's target turnaround is 180 days for an initial review of a generic drug submission. [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339]

Apotex's three filings, if counted individually, account for a third of the known pending applications. Health Canada's public generic submissions tracker lists Apotex Inc. as an applicant for multiple drug classes, including other complex molecules. [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html]

Why Apotex matters

Apotex is the largest drug manufacturer in Canada. It was founded in 1974 by Barry Sherman and sold to U.S. private equity firm SK Capital Partners LP in 2022 by Mr. Sherman's family, after Mr. Sherman and his wife were killed. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/] The Globe and Mail has reported that Apotex's owners are planning an initial public offering for the company this year. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, told the Globe that being first to market with a generic carries "an enormous first-mover advantage, as it would allow the first company to establish contracts and supply chains." [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Delays and back-and-forth

No generic semaglutide has been approved in Canada since the country became the first major market where generic semaglutide became legal on Jan. 5. [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Health Canada spokesperson Marie-Pier Burelle told the Globe 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. This time does not count toward the 180-day target." She said 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/]

Prof. Law said the timelines suggest "a lot of back-and-forth discussions between the regulator and drug manufacturers," adding: "We have no idea of what the nature of the requests are and the level of burden being put on manufacturers in this case." [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]

Current Canadian pricing

A monthly supply of brand-name semaglutide in Canada costs between $300 and $400, sometimes more depending on the dose, according to Dr. David Macklin, director of the Medcan Weight Management Program in Toronto. [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339] Current pharmacy prices tracked on GLP1Prices.ca show Ozempic ranging $222–$663, Wegovy $270–$599, and tirzepatide products Mounjaro and Zepbound in similar ranges.

Readers can follow ongoing approval updates via our generic semaglutide tracker, check plan details with our insurance coverage checker, or consult the FAQ.

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