Health Canada Reviewing 8 More Generic Semaglutide Submissions

Health Canada says it is currently reviewing eight additional generic semaglutide submissions from other companies and expects to issue decisions on them in the coming weeks and months, following its first generic semaglutide approval announced April 28, 2026 [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/].

Eight applications still in queue

The department confirmed that beyond the first generic semaglutide approval granted to Dr. Reddy's Laboratories, eight other generic semaglutide submissions remain under active review [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566]. Health Canada said it expects to make decisions on those remaining files in the next few weeks and months [Source: cbc.ca/news/health/ozempic-generic-health-canada-9.7180566].

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/generic-alert]. 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/generic-alert].

Six-month review target

Health Canada said the Dr. Reddy's submission, which was filed in early 2024, met its target review timeline of six months because the timeline excludes periods when the department is awaiting additional data or information from the applicant [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/]. The department described generic versions of semaglutide as complex synthetic products that are pharmaceutically equivalent to the brand-name biologic drug [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/].

Canada is the first G7 country to authorize a generic semaglutide product, according to Health Canada [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/]. The Dr. Reddy's product, which is sold in India under the brand name Obeda, is approved in Canada for the once-weekly treatment of Type 2 diabetes in adults [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/].

Pricing implications

Health Canada said in its news release that many generic medications are 45 to 90 per cent cheaper than brand-name versions [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/]. 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: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/]. Once a second generic enters the market, the price for both drops to 50 per cent of brand. When three or more generic products are available, prices fall to about 35 per cent of brand-name Ozempic [Source: globalnews.ca/news/11821381/health-canada-generic-ozempic-semaglutide-approval/].

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 $200 to $663 for Ozempic and $270 to $550 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.

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