Health Canada Approves First Generic Version of Ozempic

Health Canada Approves First Generic Version of Ozempic
Boxes of the diabetes drug Ozempic rest on a pharmacy counter in Los Angeles, on April 17, 2023. Mario Tama/Getty Images
|Updated:
0:00

Health Canada has approved the first generic version of Ozempic, the brand-name diabetes drug made by Danish pharmaceutical company Novo Nordisk.

The department said in a news release that it authorized a generic semaglutide injection submitted by Dr. Reddy’s Laboratories after reviewing evidence showing the product met Health Canada’s requirements for safety, efficacy, and quality for generic drugs.

According to the department, it is the first generic semaglutide approved in Canada and the first authorized in any G7 country.

Health Canada said it is also reviewing eight other generic semaglutide submissions from different companies and expects to make additional regulatory decisions in the coming weeks and months.

Semaglutide is a GLP-1 receptor agonist that mimics a naturally occurring hormone to help regulate blood sugar, reduce appetite, and slow gastric emptying. It is sold under various brand names for the treatment of Type 2 diabetes, chronic weight management, and the reduction of cardiovascular risk in some adults.

The approval comes amid strong demand for semaglutide-based medicines in Canada and globally, driven by their growing use in diabetes treatment and weight management. It also follows the expiry of Ozempic’s main data exclusivity and patent protections in Canada on Jan. 4, 2026.

Health Canada said generic medicines in Canada are typically 45 to 90 percent less expensive than brand-name equivalents, offering the potential for savings for patients and the health care system.

According to the Canadian Institute for Health Information (CIHI), Ozempic became the largest single contributor to growth in publicly funded drug spending in Canada in 2024, accounting for 8.5 percent of the overall 9.2 percent increase in public drug plan costs.

“It’s rare that we see a single medication shift prescribing and public spending growth trends the way that Ozempic has so quickly,” Tracy Johnson, CIHI’s director of health spending, said in a statement. “This drug is changing how chronic conditions like diabetes and obesity are managed and shows how rapidly new therapies can reshape both treatments and cost pressures on health systems.”

The World Health Organization (WHO) has also addressed semaglutide medicines in recent years, warning in 2024 about counterfeit Ozempic products and issuing a 2025 safety alert concerning a rare vision-loss risk associated with semaglutide drugs. The WHO later endorsed GLP-1 therapies such as semaglutide as a treatment option for obesity under medical supervision.

Health Canada did not specify when the generic version would become commercially available or what price it would carry in Canada.