Second Generic Semaglutide Cleared; 7 Submissions Still Pending

Health Canada authorized a second generic semaglutide injection on May 1, 2026, with the department confirming that seven additional generic semaglutide submissions remain under active review [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Apotex submission clears review

The second authorization went to a submission 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 drug met its criteria for safety, efficacy and quality for generic drugs after a thorough review of the evidence provided by the company [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Like the first generic semaglutide authorized April 28, 2026, the Apotex injection 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/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. The first authorization went to a submission filed by Dr. Reddy's Laboratories, making Canada the first G7 country to approve a generic version of semaglutide [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Queue drops from eight to seven

At the time of the first approval on April 28, Health Canada said it was reviewing eight other generic semaglutide submissions [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. Following the second authorization, the department now lists seven other submissions for generic semaglutide under review and said it expects to make regulatory decisions on more of these 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].

According to the GLP1Prices.ca generic semaglutide tracker, the active applicants in the Canadian pipeline include Sandoz Canada, Apotex (with three separate submissions), 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 [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026].

Pricing implications of a second generic

Health Canada said in its news release accompanying the first approval that many generic medications are 45 to 90 per cent cheaper than brand-name versions [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566]. Under the pan-Canadian Pharmaceutical Alliance pricing structure, the first generic medication could be priced at 75 to 85 per cent of the brand-name list price [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026]. Once a second generic enters the market, the price for both drops to 50 per cent of brand [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026]. When three or more generic products are available, prices fall to about 35 per cent of brand-name Ozempic [Source: glp1prices.ca/glp1-news/health-canada-reviewing-eight-more-generic-semaglutide-submissions-may-2026].

Mina Tadrous, an associate professor at the University of Toronto who researches drug policy, said two more generic approvals are needed before Canadians see major cost reductions [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566]. With three generics on the market, Tadrous projected the price could drop to about $100 per month or less, depending on dose [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566].

CBC News reported a monthly supply of Ozempic or Wegovy currently costs between $300 and $400, sometimes more depending on dose [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566]. Current pharmacy prices listed on GLP1Prices.ca range from $222 to $663 for Ozempic and $270 to $490 for Wegovy, depending on pharmacy and dose.

Tirzepatide products unaffected

The generic submissions under Health Canada review apply only to semaglutide. Eli Lilly's tirzepatide products Mounjaro and Zepbound remain on patent and are not part of the current generic pipeline. Patients can check the insurance coverage checker for plan-specific information.

Health Canada said it will continue to monitor the safety and effectiveness of all generic semaglutide products and will take appropriate action if any 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].

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