Apotex Wins US Tentative Nod for Generic Semaglutide, Canada Waits

Canada-based Apotex Inc. has won tentative approval from the U.S. Food and Drug Administration for a generic injectable version of semaglutide, while its three Canadian applications remain under Health Canada review more than three months after the Canadian patent expired [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Tentative US approval well ahead of patent expiry

Apotex said its injectable semaglutide product was developed with Indian pharmaceutical company Orbicular Pharmaceutical Technologies [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. An FDA tentative approval means the regulator has completed a scientific assessment, but the product cannot be sold until legal protections expire; the main U.S. patent held by Novo Nordisk expires in 2032 [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Being the first generic to launch in the U.S. market comes with 180 days of market exclusivity [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Novo Nordisk reported 2025 sales of 309-billion Danish krone, about $67-billion, more than half of which came from selling Ozempic and Wegovy in the United States [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Canadian applications still pending

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/]. 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 are 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/]. The company has not disclosed how those applications differ or whether they are in partnership with Orbicular, like the U.S. application [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Apotex spokesperson Catherine Thomas declined to comment on the Canadian applications [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Health Canada's public tracker lists Apotex Inc. among sponsors with submissions under review across multiple product categories [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html].

Health Canada says it remains on target

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/]. Health Canada spokesperson Marie-Pier Burelle wrote in a March 25 email that reviews may take longer when data is missing or additional data are required, and that the agency pauses its review while awaiting additional information from the manufacturer [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, said there appears to have been a lot of back-and-forth discussions between the regulator and drug manufacturers given the timelines [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/].

Patients waiting on cost relief

Dr. David Macklin, director of the Medcan Weight Management Program in Toronto, said a monthly supply of Ozempic or Wegovy costs between $300 and $400, sometimes more depending on the dose [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339]. Current pharmacy prices tracked on GLP1Prices.ca show Ozempic ranging from $222 to $663 CAD and Wegovy from $270 to $599 CAD per month, broadly consistent with that physician estimate.

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, and that once enough generics come online, prices could be around $100 a month or less depending on the dosage [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339].

Global generic wave

Generic semaglutide became legal in India on March 23, and a number of companies announced regulatory approval to begin selling their products that day, including two drug makers with applications pending with Health Canada [Source: theglobeandmail.com/business/economy/article-apotex-fda-approval-generic-ozempic-drug-health-canada-decisions/]. Novo Nordisk is expected to lose patent protection in countries home to 40 percent of the world's population, with generics anticipated in the coming months in China, Canada, Brazil, Turkey and South Africa [Source: nytimes.com/2026/03/19/health/ozempic-wegovy-generic-india-china-canada.html].

Readers can follow progress through our generic semaglutide tracker, the insurance coverage checker, and our FAQ. Comparable brand drugs including Mounjaro, Zepbound, and Rybelsus remain under brand-name sale in Canada.

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