Health Canada approves Dr. Reddy's generic semaglutide, a first for the G7

Health Canada cleared a generic semaglutide injection from Dr. Reddy's Laboratories on April 28, 2026, the first copy of the drug approved by any G7 regulator ^[1][2]. Apotex won authorization for a second generic on May 1, 2026 ^[3].

The Dr. Reddy's product copies Ozempic, Novo Nordisk's brand-name semaglutide shot, and carries the same labeled use: once-weekly treatment for adults with type 2 diabetes to manage blood sugar ^[1]. Regulators described generic semaglutide injections as complex synthetic products that are pharmaceutically equivalent to the brand-name reference drug ^[1]. The approval covers 2 mg and 4 mg pens at 1.34 mg/mL, and the company said launch preparations were underway ^[3]. Dr. Reddy's makes the active ingredient in-house and relies on OneSource Specialty Pharma for finished manufacturing ^[3].

Canada's review finished inside the agency's 180-day target for generics. Time a company takes to supply required or missing data does not count against that clock, and a second review round then extends the total ^[1]. Eight other generic semaglutide applications were pending when the first approval was announced ^[1][2]; that number stood at seven after Apotex's clearance ^[3].

A missed fee undid the Canadian patent

In 2019 Novo Nordisk failed to pay a CAD $250 maintenance fee on Canadian patent CA 2601784, which covers acylated GLP-1 compounds ^[3]. The original amount owed was about US $188; with the late charge it came to CAD $450, roughly US $339 ^[3]. Records show the last payment arrived Oct. 23, 2018, that the window to reverse the lapse closed Aug. 31, 2020, and that the patent is listed as "Expired and beyond the Period of Reversal" ^[3]. A certificate of supplementary protection tied to the same patent listed a March 20, 2026 expiry and would have extended protection to March 20, 2028 ^[3]. Novo Nordisk later characterized the lapse as a deliberate choice ^[3].

Health Canada said cheaper generics should benefit patients and the health system, and that many generic medicines in the country sell for 45% to 90% less than brand-name versions ^[1][2]. No price for either Canadian generic has been reported.

Ozempic is Canada's top-selling medicine, with CAD $2.9 billion in 2025 sales, more than triple the next best-selling product, and more than a million Canadians take it ^[3].

India opened to semaglutide copies in March 2026, the first major market to do so, and Novo Nordisk responded by cutting prices for Ozempic and Wegovy there ^[2]. Dr. Reddy's and Novo Nordisk did not respond to Reuters requests for comment ^[2].

Why it matters for patients

Nothing changes for U.S. patients today. Novo Nordisk's 2025 Form 20-F puts U.S. compound patent expiry for Ozempic, Rybelsus and Wegovy in 2032, while the company's patent table lists 2031 for Japan and Europe ^[3]. BMO Capital Markets analyst Evan Seigerman called Canadian generic entry "likely to remain a localized headwind," saying strong U.S. intellectual property protections should prevent meaningful spillover ^[2].

Generic makers have filed abbreviated new drug applications for Ozempic, Wegovy and Rybelsus with Paragraph IV certifications, and Novo Nordisk has settled Ozempic patent litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy's, Mylan, Zydus and Apotex. Those settlement terms are confidential, so any earlier U.S. launch dates have not been disclosed ^[3].

U.S. access has instead run through compounding during shortages, direct-to-patient and payer programs, and Medicare drug-price negotiation ^[3]. The FDA determined in February 2025 that the shortage of semaglutide injection products had been resolved, after shortages dating to 2022, then set deadlines for compounders making products that were essentially copies of approved semaglutide ^[3].

For Canadians, the open questions are what the generics will cost and whether insurers will cover them; neither has been disclosed. The approved copies are versions of Ozempic for type 2 diabetes, and no generic Wegovy for weight management has been reported in Canada ^[1][3].

What happens next

Health Canada has said it expects to make decisions on more of the remaining submissions in the coming weeks and months ^[1]. Sandoz has said it plans to launch a generic version of Ozempic in Canada by June 2026 ^[2]. No earlier U.S. generic launch date has been announced ^[3].