Health Canada Queue: 7 Semaglutide Generics Await Decisions

Health Canada said it is currently reviewing seven additional generic semaglutide submissions from different companies after authorizing its second generic semaglutide injection on May 1, 2026 [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Two approvals, seven still pending

The May 1 announcement confirmed that the department had cleared a generic semaglutide injection filed by Canadian-based Apotex, a generic version of the brand-name drug Ozempic [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. Health Canada said the department expects to make regulatory decisions on more of the remaining submissions in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

The Apotex authorization followed Health Canada's first generic semaglutide approval, granted to Dr. Reddy's Laboratories on 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]. At that time, eight other submissions were under review [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. With the Apotex file now cleared, seven semaglutide generic submissions remain in the queue [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Same indication, complex synthetic equivalence

Both authorized generic semaglutide products are indicated for the once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels, the same indication held by existing products [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. Health Canada described the generic versions of semaglutide as complex synthetic products that are pharmaceutically equivalent to the brand-name biologic drug [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 its review ensures that differences between these products do not affect the safety, efficacy, or quality of the drug, and that Health Canada will continue to monitor authorized generic semaglutide products and take action if unexpected safety or effectiveness concerns arise [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Active applicants in the Canadian pipeline

According to GLP1Prices.ca's generic semaglutide tracker, active applicants in the Canadian pipeline include Sandoz Canada, Apotex (with three separate submissions originally filed), Taro Pharmaceuticals, Aspen Pharmacare, and Teva Canada [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026]. Novo Nordisk's data exclusivity for semaglutide expired in Canada on January 4, 2026, opening the door for generic competition against Ozempic, Wegovy, and Rybelsus [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026].

Tirzepatide products from Eli Lilly — Mounjaro and Zepbound — are not part of the current generic semaglutide pipeline [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026].

Coverage conversation in focus

Obesity Canada noted 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/]. Scientific Director Dr. Sanjeev Sockalingam wrote that lower-cost, Health Canada-approved options may help reduce one of the most persistent barriers in obesity care [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

Obesity Canada said fewer than 20 per cent of Canadians with private drug benefit plans have access to Health Canada-approved obesity treatment medications, and called on governments, insurers, and employers to revisit how care is covered if lower-cost approved options become available [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/]. The organization also stated it does not endorse specific medications, brands, or manufacturers [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

What patients can do now

Patients tracking the broader pipeline can monitor Health Canada's public list of generic submissions under review, which the department updates as files are added or cleared [Source: canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html]. Plan-specific information for currently authorized products is available through the insurance coverage checker and the FAQ.

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