Canada has approved its first generic versions of Novo Nordisk A/S's Ozempic, marking a significant step toward more affordable access to popular diabetes medications. On Tuesday, Health Canada assigned drug identification numbers to semaglutide injections produced by India-based Dr. Reddy's Laboratories Ltd., according to the regulator's drug product database. Semaglutide is the active ingredient in Ozempic, and Novo's patent protection for the drug expired in Canada on January 4.
Health Canada Reviews Additional Submissions
Health Canada is currently reviewing eight other submissions for generic semaglutide from various companies, the agency stated in a Tuesday announcement. The regulator noted that it completed its review of Dr. Reddy's submission within the target timeline of 180 days. Many generic medications in Canada are 45% to 90% cheaper than their brand-name counterparts, offering substantial savings for patients.
Dr. Reddy's Launch Preparations Underway
Dr. Reddy's confirmed that the Canadian approval covers two milligram and four milligram pens. The company said launch preparations are underway but did not provide a specific timeframe. “Canada remains a priority market for us,” said Chief Executive Erez Israeli, pledging to ensure a “consistent supply” of GLP-1 treatments for diabetic patients.
Global Competition Drives Down Costs
Dozens of manufacturers have been preparing knockoff versions of Ozempic, with competition potentially slashing monthly costs to as low as US$14 for users in some countries. In March, India became the first major market to roll out generic semaglutide products, prompting Novo Nordisk to cut prices for Ozempic and Wegovy in that country. Canada had been viewed as a testing ground and a significant market in its own right. For instance, telehealth company Hims & Hers Health Inc. expanded into Canada in December, anticipating generic approvals.
Patent Expiry and Approval Delays
The gap between patent expiry and drug approval is partly due to a backlog of application reviews at Health Canada. Between 2016 and 2025, the regulator experienced a 43% increase in generic drug submissions filed, according to spokesperson Mark Johnson. The complexity of submissions has also risen, leading to a 30% increase in the average number of hours needed for review.
