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Health Canada has authorized Dr. Reddy’s Laboratories’ generic semaglutide injection, making Canada the first G7 country to approve a generic version of the GLP-1 drug. The move gives Canadian patients a regulated copy of Novo Nordisk’s Ozempic years before U.S. generic entry is expected. The authorization covers 2 mg/pen and 4 mg/pen presentations at 1.34 mg/mL, with launch preparations underway, Dr. Reddy’s said.
The generic debut comes after Novo Nordisk, in 2019, failed to pay a $250 CAD maintenance fee on Canadian patent CA 2601784. For context, the initial amount due was about $188 USD. With the late fee, the total came to $450 CAD or about $339 USD. The patent lapsed permanently. Novo Nordisk later claimed this was a strategic choice. Derek Lowe at Science first flagged it publicly.
The Canadian authorization comes amidst a broader effort to extend access to semaglutide. In the U.S., access has moved through several channels, including compounding during shortages, direct-to-patient and payer programs and Medicare drug-price negotiation. FDA determined in February 2025 that the shortage of semaglutide injection products had been resolved. Before that, the drugs had been in shortage since 2022 because of sustained heightened demand. The agency then set deadlines for compounders making products that were essentially copies of FDA-approved semaglutide products.
Health Canada reviewed Dr. Reddy’s submission as a generic version of Ozempic and reasoned that the product met its criteria for safety, efficacy and quality. The agency also described generic semaglutide injections as complex synthetic products that are pharmaceutically equivalent to the brand-name reference product.
The Canadian Patents Database lists Novo Nordisk’s CA 2601784, “Acylated GLP-1 compounds,” as expired. The same record shows the patent’s last maintenance-fee payment was received Oct. 23, 2018, and that the time limit for reversal expired Aug. 31, 2020. Canada’s certificate of supplementary protection register lists semaglutide with patent 2601784, a March 20, 2026 patent expiry date and a CSP term that would have extended to March 20, 2028. That sequence left Canada open to generic competition far earlier than other major markets. Canadian Patents Database notes the status as: “Expired and beyond the Period of Reversal.”
In the U.S., Novo Nordisk said in its 2025 Form 20-F that U.S. compound patent expiry for semaglutide products Ozempic, Rybelsus and Wegovy is 2032. Novo also disclosed that several manufacturers filed abbreviated new drug applications for generic versions of Ozempic, Wegovy and Rybelsus with Paragraph IV certifications. It settled U.S. Ozempic patent litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy’s, Mylan, Zydus and Apotex. The settlement terms are confidential.
For Dr. Reddy’s, the approval boosts its position in complex generics and peptide therapeutics. The company said the semaglutide active pharmaceutical ingredient is produced entirely in-house, with finished product manufacturing handled by OneSource Specialty Pharma. For the broader GLP-1 market, Canada’s first generic semaglutide approval shows how the access debate is shifting from shortage-era workarounds to formal generic competition, with each country’s patent rules determining the pace.
Semaglutide has become one of the most consequential molecular franchises in pharma in recent memory. Across Ozempic, Wegovy and Rybelsus, Novo Nordisk reported FY2025 sales of more than DKK 228 billion, including DKK 127.1 billion for Ozempic and DKK 22.1 billion for Rybelsus, while obesity-care sales, driven largely by Wegovy, reached DKK 82.3 billion. The molecule also validated GLP-1 drugs at a commercial scale that helped define the market now contested by Lilly’s tirzepatide, a dual GIP/GLP-1 receptor agonist. Canada became the first G7 country to approve a generic semaglutide in April 2026, after Novo Nordisk failed to maintain a key Canadian patent covering acylated GLP-1 compounds. Health Canada authorized Dr. Reddy’s generic semaglutide injection after reviewing the submission as a generic version of Ozempic, while Dr. Reddy’s said it was the first company to receive Canadian marketing authorization for generic semaglutide injection. In the U.S., Japan and Europe, Novo’s own patent table lists active-ingredient protection for Ozempic, Wegovy and Rybelsus running to 2032 in the U.S. and 2031 in Japan and Europe.
Health Canada has already approved two generics (Dr. Reddy’s on April 28, Apotex on May 1) and is reviewing seven more submissions
Filed Under: Metabolic disease/endicrinology, Uncategorized
