Health Canada Backlog Pushes Generic Semaglutide Past Jan. 4

Sandoz Canada says the arrival of generic versions of Ozempic will likely slip past the January 4 patent expiry because of a continuing backlog of new drug submissions at Health Canada.

Seven filers, one backlog

Seven drug manufacturers have filed generic semaglutide submissions with Health Canada, the first in February 2024. Canada is the first major market in the world where generic semaglutide will be legal, with market exclusivity for the molecule ending January 4.

Sandoz Canada Inc., a subsidiary of Sandoz Group AG, filed its application in November 2024 and, a year later, is still answering questions from Health Canada about its submission. Michel Robidoux, general manager of Sandoz Canada, said the road to approval is probably longer than expected and that the industry is not expecting generic semaglutide to have a major place in the Canadian market until mid-2026.

Health Canada's 180-day target

Health Canada has a target of responding to all generic submissions within 180 days but hit that target only 84 per cent of the time in the fiscal year that ended March 31. In most cases where the target was met, the applications were rejected within days of the 180-day deadline and then accepted after further review.

The Canadian Generic Pharmaceutical Association reported earlier in November that more than 500 generic submissions were under review, of which more than 100 were backlogged. Association president Jim Keon said every day of delay in approving these medicines costs the health care system millions and denies drug plans the savings needed to fund new treatments.

Complex molecule, extra data

Robidoux acknowledged that chemical complexity is adding to regulatory complications for the synthesized versions of semaglutide that Sandoz and other companies are proposing, and that Health Canada has requested more data than it would on a more standard generic submission.

Indian pharmaceutical company Dr. Reddy's Laboratories Ltd., which submitted to Health Canada in February or March last year, recently disclosed that it had received a notice of non-compliance indicating the company still had further questions to answer about its submission.

By contrast, Brazil's health regulator proactively notified drugmakers three months ago that it would prioritize generic semaglutide submissions ahead of Ozempic's patent expiry there in March.

Market context in Canada

According to Novo Nordisk, more than a million people in Canada currently take a semaglutide product. Health Canada confirmed on January 27, 2025 that the supply of Ozempic and other GLP-1 receptor agonists had stabilized and was available across the country, resolving an earlier supply notice first published in April 2023.

The supply notice listed Ozempic (semaglutide), Trulicity (dulaglutide) and Mounjaro (tirzepatide) among the affected products.

Government response

Health Minister Marjorie Michel's office said it is working on the issue, with spokesperson Guillaume Bertrand stating that the approval process currently takes too long and that bureaucracy is getting in the way of delivering essential medications to Canadians. Prime Minister Mark Carney's election platform in April promised to speed up drug approvals in Canada, though the federal budget tabled this month did not mention the issue.

Readers tracking brand-level pricing for Wegovy, Rybelsus and Zepbound can follow updates on our generic semaglutide tracker and check plan details through our insurance coverage checker.

This article is for informational purposes only and does not constitute medical advice.

Sources

• Health Canada approval backlog expected to push back ...
• Supply of Ozempic and other GLP-1 receptor agonists: Notice