Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic semaglutide in the US, the first semaglutide generics have now been approved in Canada.
On 29 April 2026, Dr Reddy’s Laboratories announced that it was the first company to receive approval from Health Canada for its generic semaglutide injection for the treatment of type 2 diabetes in adults. The approval covers two formulations: 2mg/pen (1.34mg/mL) and 4mg/pen (1.34mg/mL). While no launch date has been announced, Dr Reddy’s has “launch plans underway”.
Days later, on 1 May 2026, Apotex announced that its Apo-Semaglutide Injection™ was approved by Health Canada. The approval covers two prefilled pen formats: 0.25 mg or 0.5 mg doses (containing 2 mg of semaglutide 0.68mg/mL) and 1 mg doses (containing 4 mg of semaglutide 1.34 mg/mL). Apo-Semaglutide Injection™ was developed by Apotex through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India.
Dr Reddy’s and Apotex are active in the generic semaglutide space, with Dr Reddy’s one of the first companies to receive approval for, and launch, generic semaglutide in India (under the name Obeda™) and Apotex receiving the first US FDA Tentative Approval for its generic semaglutide ANDA, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.
It has previously been reported that Health Canada is reviewing numerous submissions for generic semaglutide, including applications by Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz (which is planning a 2026 generic semaglutide launch in Canada). Further generic semaglutide approvals are therefore expected in Canada in the coming weeks and months.