Health Canada reviewing eight more generic semaglutide files

Health Canada is reviewing eight additional generic semaglutide submissions as of September 8, 2026, according to an approval tracker that lists three of nine generic semaglutide products as approved ^[1]. The authorized products described in reporting are generic semaglutide injections from India-based Dr. Reddy's Laboratories and Canadian manufacturer Apotex ^[2].

The counts in the two accounts do not match. A September 1 report said Health Canada had authorized two generic semaglutide injections, with seven other applications still under review ^[2]. The tracker lists eight files still under review as of September 8 and counts three of nine generic semaglutide products as approved ^[1]. The tracker separately notes that Aspen-Semaglutide and Sevmia were listed as approved but not marketed as of July 28, 2026 ^[1], which may account for part of the difference. No decision dates for the pending files have been reported ^[1][2].

Dr. Reddy's generic became available in Canada on May 15, 2026 ^[2]. Apotex has not announced a release date, and the tracker says its offering has full SKU parity with Ozempic, meaning the same range of package sizes and strengths ^[1][2].

How the price is set

Canadian generic pricing follows a framework tied to the number of manufacturers selling. Tadrous, a pharmacist and drug policy researcher at the University of Toronto, told CBC News that with one generic, prices fall to 75% of the brand list price; with two, to 50%; and with three or more, to 35% ^[2]. The tracker describes the first entrant at 75% to 85% of brand and the same 35% level once three or more generics reach the market ^[1].

Tadrous estimated to The BMJ that out-of-pocket costs should reach around C$100 per month once three generics are on the market ^[2]. Brand Ozempic prices tracked in Canada range from C$86.40 to C$663, and Wegovy from C$270 to C$550 ^[2].

The Canadian approvals followed two events described in BMJ reporting: Novo Nordisk stopped paying a C$250 annual patent maintenance fee starting in 2018, and a separate regulatory approval requirement expired on January 5, 2026 ^[2]. Tahir Amin, CEO of the Initiative for Medicines, Access & Knowledge, told the BBC the Canadian patent could have been extended until 2028 but was not renewed. "Somebody dropped the ball ... that's why you've got generics in Canada sooner," Amin said ^[2].

Novo Nordisk has not publicly explained the lapse, telling The BMJ that "all intellectual property decisions are carefully considered at the global level" ^[2]. The company told the BBC that Canada is "a localized situation based on our specific patent timelines and regulatory environment and does not reflect the situation in the United States, where exclusivity remains intact" ^[2]. Novo Nordisk earned roughly US$29 billion from semaglutide products in 2024, including US$17.5 billion from Ozempic ^[2].

Novo Nordisk is offering brand-name discount cards to cover the price gap and has launched a Canadian advertising campaign encouraging patients to ask for brand-name Ozempic ^[2]. Tadrous told The BMJ he expects the company to retain more market share than is typical after generic entry ^[2]. Novo Nordisk forecast that 2026 sales would fall 5% to 13%; its share price fell 17% on the day the guidance was announced, and CEO Mike Doustdar described 2026 as "a year of unprecedented pricing pressure" ^[2].

Why it matters for patients

The Canadian changes do not alter what is available or what it costs in the United States. Novo Nordisk retains semaglutide patent protection in the US until 2032 and in Europe and Japan until 2033 ^[2], and the company says US exclusivity remains intact ^[2].

For patients in Canada, the practical trigger is the third generic. Canadian benefits plans face a 65% list-price cut once a third generic semaglutide launches ^[1], and the C$100-a-month estimate applies only at that point, not with two products selling ^[2].

Generic competition in Canada is so far limited to semaglutide, the molecule in Ozempic, Wegovy and Rybelsus. Tirzepatide, sold as Mounjaro and Zepbound, is projected to overtake semaglutide as the leading GLP-1 product within the next few years, per The BMJ ^[2]. Sandoz has estimated its proposed generic tirzepatide at C$200 to C$400 per month in Canada ^[1].

What happens next

Apotex has given no release date for its generic semaglutide ^[2]. The tracker lists Sandoz targeting the third quarter of 2026 and Aspen going Canada-first ^[1]. As of early August, the Canadian Generic Pharmaceutical Association said more than 500 generic submissions sat with Health Canada, with more than 100 backlogged, while seven generic semaglutide files awaited decisions ^[1]. It has not been reported when Health Canada will rule on the eight files now under review ^[1][2].