BMJ: Canada Is Only the Second Country to Clear Generic Semaglutide
Canada has become only the second country in the world to approve a generic form of semaglutide, the active ingredient in Novo Nordisk's Ozempic, according to a report published in The BMJ on May 19, 2026 [Source: bmj.com/content/393/bmj-2026-597166].
What The BMJ reported
Writing from St Stephen, New Brunswick, BMJ correspondent Brian Owens reported that two generic versions of injectable semaglutide have been approved by Health Canada in recent weeks β one from India's Dr. Reddy's Laboratories and one from Canadian manufacturer Apotex [Source: bmj.com/content/393/bmj-2026-597166]. Seven other generic semaglutide applications are still under review by Health Canada, according to the same report [Source: bmj.com/content/393/bmj-2026-597166].
The BMJ also reported that the situation was made possible after Novo Nordisk did not pay a C$250 annual maintenance fee, a decision that ended Canadian patent protection earlier than in most other markets [Source: bmj.com/content/393/bmj-2026-597166].
How Health Canada framed the decision
Health Canada said in an April 28, 2026 announcement that it had authorized the first generic semaglutide injection, calling it the first such approval in the G7 [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. The department said the Dr. Reddy's submission is a generic version of brand-name Ozempic and is indicated for the once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].
At the time of the April 28 announcement, Health Canada said it was reviewing eight other submissions for generic semaglutide from different companies and expected to make regulatory decisions on more of these submissions in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].
Market availability
According to The BMJ, the Dr. Reddy's generic semaglutide became available in Canada on May 15, 2026, while the Apotex version did not yet have a release date as of the BMJ report [Source: bmj.com/content/393/bmj-2026-597166]. The BMJ quoted Erez Israeli, chief executive of Dr. Reddy's, who said in a press release: "As the first company to receive market authorisation for generic semaglutide injection in Canada, we remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 [glucagon-like peptide-1] treatments for patients with diabetes in the country" [Source: bmj.com/content/393/bmj-2026-597166].
The broader Canadian patent picture
Benefits and Pensions Monitor reported that the core patent for semaglutide lapsed in Canada after missed maintenance fee payments and the expiry of data exclusivity on January 4 [Source: benefitsandpensionsmonitor.com/benefits/pharma/ozempic-generics-set-to-test-canadas-drug-budgets/392976]. The publication noted that once three generic competitors are on the market, Canadian policy will drive list-price discounts of about 65 percent [Source: benefitsandpensionsmonitor.com/benefits/pharma/ozempic-generics-set-to-test-canadas-drug-budgets/392976].
Benefits and Pensions Monitor also reported that Sandoz had originally aimed to launch in the first half of 2026 but now expects the Canadian generic market to take shape in the third quarter of 2026, according to Sandoz CEO Richard Saynor, after both Sandoz and Reddy's Laboratories were told they must provide more data to meet regulatory standards [Source: benefitsandpensionsmonitor.com/benefits/pharma/ozempic-generics-set-to-test-canadas-drug-budgets/392976].
Current Canadian price landscape
For Canadians comparing retail options, current pharmacy prices on GLP1Prices.ca show Ozempic ranging from approximately C$215 to C$663 per pen, and Wegovy ranging from approximately C$270 to C$550 per pen, based on listings across Canadian pharmacies. Brand tirzepatide products Mounjaro and Zepbound remain under patent in Canada and are not affected by the semaglutide ruling.
- BMJ report date: May 19, 2026 [Source: bmj.com/content/393/bmj-2026-597166]
- Health Canada first generic authorization: April 28, 2026 [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]
- Dr. Reddy's pharmacy availability: May 15, 2026 [Source: bmj.com/content/393/bmj-2026-597166]
- Other applications under Health Canada review at time of BMJ report: seven [Source: bmj.com/content/393/bmj-2026-597166]
Readers can follow ongoing approvals through our generic semaglutide tracker, check plan status with our insurance coverage checker, or review common questions in the FAQ.
This article is for informational purposes only and does not constitute medical advice.
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