Canadians could save billions in next decade if off-patent drugs get to market quickly, report says

More than 300 drugs will go off-patent in Canada in the next decade, bringing potential savings of $94-billion to insurance plans – as long as red tape doesn’t get in the way, according to new estimates from Swiss generics giant Sandoz Group AZ SDZXF.

Sandoz’s Canadian branch released an analysis Wednesday that quantifies the market size of drugs losing their legal protections in the coming years and identifies some government and insurance bottlenecks that might keep those medicines from patients.

The speed of regulatory approvals has become a top concern for the generic drug industry in Canada. As The Globe and Mail reported in August, the backlog of generic submissions has doubled in the past year. Health Canada has a target of assessing submissions within 180 days, which was met only 72 per cent of the time in the 2025-26 fiscal year.

The Sandoz report’s modelling suggests that, without generic options, public and private payers would pay $183-billion on more than 300 drugs when they go off-patent – or $89-billion if cheaper off-patent drugs were promptly available when legal.

“This is a great opportunity to reduce health care costs,” said Michel Robidoux, president and general manager of Sandoz Canada.

In the analysis, the single biggest year for new generics becoming available was 2026, largely because the market protections expired for Ozempic, the blockbuster diabetes and obesity drug made by Danish drug maker Novo Nordisk, which contains the active ingredient semaglutide.

Opinion: The Ozempic era is bringing fatphobia back – and dividing my community

Although those protections expired on Jan. 4, and some drug companies applied to make generic forms of Ozempic nearly two years earlier, Health Canada did not approve the first generic until April 28. The products began to hit pharmacy shelves by the end of May.

Sandoz, which first applied to Health Canada to make generic semaglutide in late 2024, got its first approval in September and hopes the product will be in pharmacies in the coming weeks. This product is being made in India.

Mr. Robidoux said Sandoz is also working with a Canadian manufacturer to produce generic semaglutide in the country, but that application has yet to be approved.

In the meantime, the Canadian facility has already begun producing generic semaglutide, he said – and it is being shipped to Brazil, which has already approved it.

Brazil’s health authority, Mr. Robidoux said, “told the manufacturer community: Anyone who is going to submit a semaglutide dossier, you will be prioritized” in recognition of the high demand for the drug.

Health Canada, the regulator responsible for approving and authorizing the sale of new generics, has said its delays are a result of the increasing volume and complexity of generic drug submissions. The industry has said the department should hire more reviewers, and pointed to the fees that companies pay with their submission. The fee for the most common generic submission type is about $71,950 this year.

“What we’re telling Health Canada is, if you think you’re busy now, look at the the golden decade,” Mr. Robidoux said, referring to the analysis, which is titled “A Golden Decade of Loss of Exclusivity for Affordable Medicines in Canada.”

Fresh off an IPO and launching a generic GLP-1, Apotex CEO Jeff Watson has even bigger plans

Sandoz’s first recommendation is for the department to start hitting its timeline targets. The company also suggests Health Canada expand a new initiative, called a reliance order, to include generics. The government said in July it would start speeding up the review of some patented drugs that have been approved by selected foreign regulators, including the U.S. Food and Drug Administration and the European Medicines Agency. But so far the program is aimed just at certain pediatric and veterinary drugs.

Sandoz is also recommending private insurers adopt policies like many provincial health plans have to switch patients on costly biologic drugs to lower-cost biosimilar drugs when they become available.

Biosimilars are near-copies of the brand-name versions of biologics, a class of drugs made from living cells.

Biosimilar-switching policies were controversial when first introduced, but a review published in 2024 found British Columbia saved more than $730-million over five years through the program, which the province said it spent to expand drug coverage.

Health Canada did not respond to questions by deadline on Wednesday.

Generic drug prices in Canada are set out in an agreement between the industry and public health plans. When the first generic version of an off-patent drug is launched, it is priced at 75 per cent or 85 per cent of the brand-name list price. That eventually falls to 25 per cent or 35 per cent once three or more generic versions are on the market, with the price depending on the type of drug.

Generics and biosimilars made up nearly 80 per cent of prescriptions filled out in Canada in 2025, according to industry data cited in Sandoz’s report, but, because they are cheaper, only represented a quarter of the total money spent on prescription drugs that year.