Health Canada's 73% Initial-Rejection Rate Shapes Generic Queue

Health Canada issued initial rejections on 73 per cent of generic drug submissions in the 2024-25 fiscal year, though 90 per cent were eventually approved, a pattern now shaping the pace at which generic semaglutide applicants reach Canadian pharmacy shelves.

The notice-of-non-compliance pattern

Dr. Reddy's Laboratories disclosed in regulatory filings that Health Canada issued a notice of non-compliance on its semaglutide submission, with company secretary K Randhir Singh writing to shareholders that the notice "outlines requests for additional information and clarifications on specific aspects of the submission". Dr. Reddy's chief executive officer Erez Israeli said on a July 23 earnings call that the company had been prioritizing a Canadian launch in January 2026, ahead of its home market in India where the semaglutide patent expires in March.

The Globe and Mail reported that the initial-rejection pattern has been part of what generic drug manufacturers describe as a slowdown in getting products to market in Canada. Health Canada's target review time for generic submissions is 180 days, which does not include extra time if the regulator requests more data.

Why semaglutide submissions take longer

Health Canada views semaglutide generics as more complex to assess because they are "complex synthetic products" that must still match the brand on safety, efficacy and quality. Under the standard pathway, companies file an Abbreviated New Drug Submission (ANDS) demonstrating bioequivalence; if the Health Products and Food Branch review confirms all regulatory requirements are met, the drug is issued a Notice of Compliance and a Drug Identification Number.

Novo Nordisk's data exclusivity for semaglutide expired on January 4, 2026, opening the pathway for generic approvals of Ozempic, Wegovy and Rybelsus equivalents.

The queue so far

As of December 29, Health Canada had nine generic semaglutide submissions on file, including filings from Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada. A new Canadian company, Vimy Pharma, founded by two former Novo Nordisk Canada executives, has also said it plans to launch a generic semaglutide.

Health Canada authorized the first generic semaglutide injection on April 28, 2026, filed by Dr. Reddy's Laboratories, and authorized a second generic semaglutide injection filed by Apotex on May 1, 2026. At the time of the first authorization, eight other submissions remained under review.

Pricing framework behind the queue

Generic prices for semaglutide will depend on how many competitors reach the market. Under the agreement between the pan-Canadian Pharmaceutical Alliance and the Canadian Generic Pharmaceutical Association, a single generic injectable is listed at 85, 75 or 55 per cent of the brand price depending on provincial listing agreements, two generics bring a 50 per cent discount, and three or more set the injectable price at 35 per cent of brand.

The current list price of Ozempic in Canada is $223 for a four-week dose, before markups from pharmacies and wholesalers. Current pharmacy prices tracked on GLP1Prices.ca range from $86.40 to $663 for Ozempic across 87 listings. Health Canada has stated that many generic medicines in Canada are 45% to 90% cheaper than their brand-name counterparts.

What remains outside the queue

Only semaglutide has lost regulatory exclusivity in Canada. Eli Lilly still holds its Canadian patent for Mounjaro and Zepbound, with no imminent patent expiry.

Canadians tracking pending Health Canada decisions can follow our generic semaglutide tracker, review plan options through our insurance coverage checker, or review background questions in our FAQ.

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

Sources

• Indian pharma giant says Health Canada rejected its ...
• Generic semaglutide shift tests benefit plans as Canada ...
• Access to Generic Drugs in Canada
• Generic Ozempic coming to Canada: what the patent ...