Apotex wins Health Canada approval for generic semaglutide injection
Canada now has two approved generic versions of Ozempic's semaglutide three days apart, but the approvals do not change what US pharmacies stock.
Apotex said on May 1, 2026 that Health Canada approved Apo-Semaglutide Injection, making it the second generic version of Ozempic (semaglutide) cleared for sale in Canada in three days [1].
Two approvals, three days apart
Dr Reddy's Laboratories announced on April 29, 2026 that it was the first company to receive Health Canada approval for a generic semaglutide injection [1]. That approval is for the treatment of type 2 diabetes in adults and covers two formulations: a 2 mg pen and a 4 mg pen, both at a concentration of 1.34 mg/mL [1]. The company has not announced a launch date, but says it has launch plans underway [1].
Apotex's approval covers two prefilled pen formats: one containing 2 mg of semaglutide at 0.68 mg/mL for 0.25 mg or 0.5 mg doses, and one containing 4 mg at 1.34 mg/mL for 1 mg doses [1]. Apotex says the product was developed through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India, and describes itself as the first Canadian-based global pharmaceutical company to receive Health Canada approval for a generic equivalent of Ozempic [1].
Whether Apotex's approval covers weight management or other uses beyond type 2 diabetes has not been reported. Dr Reddy's approval is specifically for type 2 diabetes in adults [1]. Neither company has disclosed pricing for the Canadian products.
Both companies are already competing in the broader generic semaglutide market. Dr Reddy's was among the first to win approval for and launch a generic semaglutide in India in March 2026, under the name Obeda, alongside Zydus, Alkem, Sun Pharma and Glenmark [1]. Apotex received the first US Food and Drug Administration tentative approval for its generic semaglutide application on April 10, 2026, and the company says that positions it to be one of the first to launch a generic Ozempic in the United States once Novo Nordisk's exclusivity and patents expire [1].
Why it matters for patients
These are Canadian decisions. They do not change which semaglutide products are available at US pharmacies, and no generic semaglutide has been cleared for sale in the United States [1]. A tentative FDA approval is not a full approval. The only thing it changes for now is timing: Apotex has an early place in line whenever US exclusivity and patents lapse [1].
For patients in Canada, two approved products create the possibility of competition on price, but prices have not been disclosed for either one, so any savings are not yet known [1]. The approvals also cover injectable semaglutide only. Oral semaglutide (Rybelsus) and the higher-dose Wegovy products are separate presentations, and the announcements do not address whether generic versions of those are approved [1].
Semaglutide is the molecule in Ozempic, Wegovy and Rybelsus. Tirzepatide, sold as Mounjaro and Zepbound, is a different drug and is not affected by these approvals [1].
What happens next
Health Canada is reviewing a number of other generic semaglutide submissions, including applications from Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz, which has said it plans a 2026 generic semaglutide launch in Canada [1]. Further Canadian approvals are expected in the coming weeks and months [1].
No date has been reported for when either approved product will reach Canadian pharmacies, and no date has been reported for a US generic launch [1].
Sources
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