Health Canada approves the first generic semaglutide in the G7

Health Canada authorized a generic version of semaglutide injection on April 28, 2026, making Canada the first G7 country to approve a generic copy of the drug sold as Ozempic ^[1]. The approved product comes from Dr. Reddy's Laboratories and is cleared for the same use as the brand: once-weekly treatment of adults with type 2 diabetes to manage blood sugar ^[1].

Health Canada said it completed the review within its 180-day target for generic submissions and that the product met its criteria for safety, efficacy and quality ^[1]. The agency described generic semaglutide injections as "complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug" and said its review confirms that differences between products do not affect safety, efficacy or quality ^[1]. Dr. Reddy's authorization covers 2 mg/pen and 4 mg/pen presentations at 1.34 mg/mL, with launch preparations underway, according to the company ^[3]. Dr. Reddy's says it makes the semaglutide active ingredient entirely in-house, with finished product manufacturing handled by OneSource Specialty Pharma ^[3].

More approvals are coming. Health Canada said it was reviewing eight other generic semaglutide submissions from different companies and expected decisions "in the coming weeks and months" ^[1][2]. Apotex was approved on May 1, 2026, leaving seven submissions still under review ^[3]. Sandoz has said it plans to launch a generic version of Ozempic in Canada by June 2026 ^[2]. In Canada, many generic medicines sell for 45% to 90% less than the brand-name versions ^[1][2].

How a missed fee opened the door

The Canadian opening traces back to an unpaid bill. In 2019, Novo Nordisk did not pay a CAD $250 maintenance fee on Canadian patent CA 2601784, "Acylated GLP-1 compounds" ^[3]. With the late fee, the total would have come to CAD $450, roughly $339 USD ^[3]. The patent lapsed permanently; the Canadian Patents Database lists its last maintenance-fee payment as received Oct. 23, 2018, and the time limit for reversal as expired Aug. 31, 2020, with status "Expired and beyond the Period of Reversal" ^[3]. Canada's certificate of supplementary protection register listed semaglutide with that patent, a March 20, 2026 expiry and a protection term that would have run to March 20, 2028 ^[3]. Novo Nordisk later said the lapse was a strategic choice ^[3].

The stakes in Canada are large: Ozempic was the country's best-selling drug in 2025 at $2.9 billion in sales, more than three times the next-biggest product, and more than a million Canadians take it ^[3].

Why it matters for patients

For people in the United States, the practical answer is that nothing changes at the pharmacy counter. Novo Nordisk's 2025 Form 20-F lists US compound patent expiry for semaglutide products Ozempic, Rybelsus and Wegovy as 2032, with active-ingredient protection running to 2031 in Japan and Europe ^[3]. One BMO Capital Markets analyst told Reuters that Canadian generic entry is "likely to remain a localized headwind" and that strong US intellectual property protections should prevent meaningful spillover ^[2]. Some published patent listings point to specific US dates — compound protection into December 2031 and method-of-use claims into 2033 — that run slightly past the round "2032" figure Novo cites; the sources here do not resolve that difference, and the exact US expiration dates are not spelled out in them.

US generic entry also depends on litigation that is already underway. Novo disclosed that several manufacturers filed abbreviated new drug applications for generic Ozempic, Wegovy and Rybelsus with Paragraph IV certifications, and that it settled US Ozempic patent litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy's, Mylan, Zydus and Apotex ^[3]. Those settlement terms are confidential, so the dates when US generics could launch are not publicly known ^[3].

Buying a Canadian generic is not a simple workaround for US residents; the sources do not address importation rules or cross-border purchasing.

What happens next

Health Canada said more generic decisions are expected in the weeks and months after April 28, 2026 ^[1]. Sandoz has targeted a Canadian launch by June 2026 ^[2]. Analysts plan to watch Canada as a test case for whether generics can compete with branded peptide drugs on price ^[2].