On 18 September 2026, Sandoz announced that Health Canada has approved Sandoz® Semaglutide, a generic version of Novo Nordisk’s Ozempic® (semaglutide). This is in line with Sandoz’s expectations for a 2026 launch of the product.
Sandoz® Semaglutide is approved as a subcutaneous injection in a pre-filled pen (2 mg/pen; 1.34mg/mL; and 4 mg/pen; 1.34 mg/mL). It is indicated for once-weekly treatment of adult patients with type-2 diabetes mellitus to improve glycaemic control.
Generic semaglutide products have previously been approved in Canada for the treatment of type 2 diabetes. Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched on 14 May 2026.
On 29 June 2026, Apotex’s Sevmia™, generic version of Novo Nordisk’s Wegovy®, became the first approved generic semaglutide product in Canada indicated for weight loss.
Generic semaglutide products have also launched in India (from March 2026) and have been approved in South America (July 2026). Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, 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.
Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026. Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.