Generic Semaglutide Queue: Health Canada vs CMA Application Counts

Health Canada says it is currently reviewing eight additional generic semaglutide submissions following its April 28, 2026 authorization of a generic semaglutide injection filed by Dr. Reddy's Laboratories [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. The Canadian Medical Association, citing a late-December 2025 snapshot, reported that Health Canada had nine active applications from companies seeking to sell generic semaglutide [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

What the regulator's tracker shows

Health Canada maintains a public list of generic submissions under review, and the agency confirmed in its April 28, 2026 announcement that the Dr. Reddy's submission was the first generic semaglutide it had authorized [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 it expects to make regulatory decisions on more of the eight pending 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].

The submissions list is published on the Health Canada portal that tracks generic drug applications by active ingredient, applicant company, therapeutic class, and filing month [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html].

The CMA count and the timing gap

The CMA's consumer-facing explainer states that, as of late December 2025, Health Canada had nine active applications from companies that want to sell generic semaglutide [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada]. The difference between that figure and the eight pending submissions referenced by Health Canada on April 28 is consistent with the Dr. Reddy's application moving out of the "under review" queue when it received authorization [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

The CMA notes that before any generic reaches a pharmacy, Health Canada must confirm that it works the same way, is just as safe, and meets the same quality standards, and that the review takes time [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

How Health Canada describes the generic product

The agency described the Dr. Reddy's submission as a generic version of the brand-name drug Ozempic, 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]. Health Canada said the generic versions of semaglutide are complex synthetic products that are pharmaceutically equivalent to the brand-name biologic drug, and that its review ensures differences between these products do not affect safety, efficacy, or quality [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Obesity Canada's Scientific Director Dr. Sanjeev Sockalingam wrote that Canada is now the first G7 country to approve a generic version of semaglutide, with additional generic submissions under review as of writing on April 28, 2026 [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

Coverage rules unchanged by the approval

The CMA reiterated that Canadians still need a prescription from a licensed health care provider to obtain a GLP-1 drug, whether brand-name or generic [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada]. Coverage rules vary by province or territory:

• In Ontario, the Ontario Drug Benefit Program lists Ozempic as a Limited Use drug, meaning a doctor has to confirm it meets specific medical rules [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].
• In Alberta, the Alberta Drug Benefit List treats Ozempic as a step therapy/special authorization drug, and patients usually need to try other treatments first [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

The CMA also notes that if an insurance plan already approved Ozempic, it will usually cover the generic automatically once available, and that patients who choose to stay on the brand-name drug instead of the generic will typically pay the price difference out of pocket [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

What patients are watching

Patients and prescribers tracking the queue can consult our generic semaglutide tracker, our insurance coverage checker, and our FAQ for current information. Pricing for related products including Wegovy, Rybelsus, Mounjaro, and Zepbound is unaffected by the semaglutide-specific patent and regulatory exclusivity changes, the CMA notes, because only semaglutide is off-patent in this cycle [Source: cma.ca/healthcare-for-real/can-you-get-glp-1-drugs-canada].

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