Dr. Reddy's, Apotex Eye Global Export of Canada-Approved Generics

Canada's status as only the second country worldwide to approve a generic version of semaglutide is drawing pharmaceutical exporters toward its market, with Dr. Reddy's Laboratories confirming filings in more than 80 countries and Apotex holding a tentative U.S. Food and Drug Administration approval it hopes to convert into a launch.

Canada as launch pad

Health Canada authorized two generic semaglutide injection products in recent weeks, from India's Dr. Reddy's Laboratories and Canadian manufacturer Apotex, making Canada only the second country in the world to approve a generic form of semaglutide. Seven other applications remain under review at Health Canada. The Dr. Reddy's product became available in Canada on 15 May.

Erez Israeli, chief executive of Dr. Reddy's, told the BBC that his company had applied for approval in more than 80 countries, including the United States. Beyond Canada, he expects the company's generic GLP-1 to soon be available in South America, Africa and most of Asia — but not in the US, UK or Europe.

Apotex targets the US market

Apotex has secured a tentative approval from the U.S. Food and Drug Administration, though it cannot yet sell its generic semaglutide product in the United States. Martin Arès, chief executive of Apotex, said the company is exploring ways to bring its generic product to Americans now that it has been tentatively approved by the FDA, but confirmed it will not be on the U.S. market this year.

Apotex began shipping its Canadian product on Tuesday, according to Global News, and has said its generic semaglutide will be approximately one-third the price of Novo Nordisk's brand-name Ozempic. A Dr. Reddy's spokesperson did not disclose pricing details except to say that it will be "competitive".

Why Canada opened first

Tahir Amin, chief executive and founder of the U.S.-based Initiative for Medicines, Access & Knowledge (I-MAK), told the BBC that Novo Nordisk's patent on Ozempic could have been extended until 2028 in Canada but the company failed to renew it. Amin said the main compound patent protecting semaglutide is expected to expire in the United States in 2032. Novo Nordisk has stated that patent protection for semaglutide remains in place in Europe and Japan until 2033, and in the US until 2032.

Novo Nordisk said in a statement that the introduction of generics in Canada was 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".

Brand response in Canada

Novo Nordisk Canada said that starting Friday, eligible Canadians without public or private coverage will be able to buy Ozempic at a reduced price, "aligning their medication costs with generic alternatives," through a Novo Nordisk Savings Card. The discount is applied automatically at Novo Nordisk Care Rx operated by Rexall and can be used at pharmacies across Canada, excluding Quebec. Iain Graham, general manager at Novo Nordisk Canada, said the company is "dedicated to ensuring that eligible patients who choose Ozempic can stay on the brand because of these additional savings".

Revenue outlook for Novo Nordisk

Novo Nordisk has forecast that sales this year will fall between 5% and 13%, ending years of double-digit growth. Chief executive Mike Doustdar said the company's "2026 guidance reflects a year of unprecedented pricing pressure". The share price fell 17% on the day of the announcement.

By contrast, Eli Lilly — maker of Mounjaro and Zepbound — estimates 2026 sales at $80 billion to $83 billion, compared with $65 billion last year.

Canadian pricing context

The CBC has reported that patients can pay $400 a month for brand-name semaglutide products in Canada, and that the arrival of three or more generic manufacturers could bring the price down to under $100 for the same strength. Current pharmacy prices tracked on GLP1Prices.ca show Ozempic listings ranging from $86.40 to $663 CAD and Wegovy from $270 to $550 CAD across Canadian pharmacies. Consumers can compare current listings, use the insurance coverage checker, or follow filings via the generic semaglutide tracker.

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

Sources

• Why Canadians can now get cheaper generic Ozempic
• Ozempic generic approved in Canada after Novo Nordisk ...
• Novo Nordisk will slash Ozempic price for some, 'aligning' ...
• Wegovy and Ozempic maker forecasts sharp drop in ...
• Canadians could get more affordable version of Ozempic ...