Health Canada approves a second generic semaglutide, from Apotex

Health Canada authorized a second generic semaglutide injection on May 1, 2026, this one from the Canadian generic maker Apotex ^[1]. The approval came three days after Canada cleared the first generic version of semaglutide on April 28, 2026, making it the first G7 country to do so ^[1]. Seven more generic semaglutide submissions from other companies are still under Health Canada review, and the agency said it expects to decide on more of them "in the coming weeks and months" ^[1].

The Apotex product is a generic version of Ozempic, the once-weekly semaglutide injection ^[1]. Health Canada said it approved the drug after reviewing evidence that it meets the agency's criteria for safety, efficacy and quality for generic drugs ^[1]. Like the brand-name product it copies, the generic is indicated for once-weekly treatment of adults with type 2 diabetes to manage blood sugar — not for weight loss ^[1].

Health Canada described these generics as "complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug," and said its review confirms that differences between the products do not affect safety, efficacy or quality ^[1]. The agency said it will keep monitoring all generic semaglutide products and will act if unexpected safety or effectiveness concerns come up ^[1].

Why the patents lapsed in Canada

According to a BMJ news report, the openings for generic competition followed a paperwork lapse: Novo Nordisk did not pay a C$250 annual fee, which cleared the way for Canadian approvals ^[2]. The BMJ reported that two injectable semaglutide generics have been approved in recent weeks — one from India's Dr Reddy's Laboratories and one from Apotex — with seven other applications still pending ^[2].

The two sources frame Canada's status slightly differently. Health Canada called the country the first G7 nation to approve a generic semaglutide ^[1]. The BMJ described Canada as "only the second country in the world" to approve a generic form of Ozempic, without naming the first in the text available ^[2].

Timing of actual availability also differs between the two approved products. The Dr Reddy's version became available in Canada on May 15, while the Apotex version does not yet have a release date ^[2]. Erez Israeli, chief executive of Dr Reddy's, said in a press release that as the first company to win market authorization for generic semaglutide injection in Canada, the company remains "dedicated to expanding access to innovative, high-quality, affordable GLP-1 [glucagon-like peptide-1] treatments for patients with diabetes in the country" ^[2].

Why it matters for patients

For people in the United States, the direct effect is none: these approvals are Canadian, and the sources do not describe any change to US availability, pricing or regulatory status of semaglutide. Nothing in Health Canada's announcement addresses cross-border purchasing, and US readers cannot assume a Canadian generic is legally or practically available to them.

What the news does show is what generic competition can do to price once it arrives. Health Canada noted that in Canada, many generic medicines cost 45% to 90% less than the brand-name versions, and said broader generic availability is expected to bring potential cost savings for patients and the health system ^[1]. Whether Canadian generic semaglutide lands anywhere in that range is not stated in the sources.

It also matters which product is being copied and for what use. Both approvals cover semaglutide injection as a generic of Ozempic for adults with type 2 diabetes ^[1]. The sources do not describe approval of a generic version of Wegovy, the higher-dose semaglutide approved for weight management, or of oral semaglutide (Rybelsus). How Canadian prescribers or insurers will treat off-label use is not covered in the sources.

One more detail worth noting: Health Canada said its review target for generic drug submissions is shorter than that of many international regulators ^[1]. That is one reason Canada moved before larger markets, but it says nothing about when, or whether, other countries will follow.

What happens next

• April 28, 2026: Health Canada approves the first generic semaglutide injection ^[1].
• May 1, 2026: Health Canada approves the Apotex generic; seven more submissions remain under review ^[1].
• May 15, 2026: The Dr Reddy's generic reaches the Canadian market; the Apotex launch date has not been announced ^[2].
• Coming weeks and months: Health Canada expects decisions on more of the seven pending generic semaglutide submissions ^[1].