Health Canada accepted submissions from the Canadian company Apotex in January and from Switzerland-based Sandoz in November, according to the regulator’s website.Hollie Adams/Reuters
Generic versions of Ozempic could be available in Canada as early as next year, making Canadians among the first in the world to get cheaper copies of the type 2 diabetes drug that has become a sales and cultural juggernaut because of its weight-loss benefits.
At least four companies have applied to Health Canada to sell copies of Ozempic after its market exclusivity expires on Jan. 4, 2026. Health Canada accepted submissions from the Canadian company Apotex in January and from Switzerland-based Sandoz in November, according to the regulator’s website.
Health Canada also accepted applications from two other unnamed companies in the first quarter of last year, before the regulator enacted a policy naming the manufacturers behind generic drug submissions on April 1, 2024.
Apotex and Sandoz declined interview requests, but Sandoz’s chief executive officer Richard Saynor told Bloomberg in December that his company plans to use the Canadian market as a trial balloon for generic versions of semaglutide, the active ingredient in Ozempic. In the United States and Europe, Ozempic remains on patent for several years.
“If the price comes down from, I don’t know, a few hundred or a thousand dollars a month to a few tens of dollars a month, the patient population’s size is insane,” Mr. Saynor told the business news outlet.
The market for Ozempic in Canada is already huge: Just more than $2.5-billion worth was sold through Canadian retail pharmacies last year, according to the life-science analytics company IQVIA – making Ozempic far and away the best-selling prescription drug in the country. (IQVIA’s figures include markups and dispensing fees.)
Ozempic reached that high-water mark despite Canadian public and private drug plans generally declining to cover it for weight loss, an off-label use.
That means an untold number of Canadians are already using their own money to buy the drug, and more may be willing to do so if the price drops, according to University of British Columbia professor Michael Law, who holds a Canada Research Chair in Access to Medicines.
“We have good evidence that folks are price responsive when it comes to prescription drugs,” he said. “If the price goes down to 35 per cent of what it is now, it’s likely that there will be more people willing to pay for it out of pocket.”
Canada’s tiered pricing framework for generics dictates that injectable drugs such as Ozempic be sold at 35 per cent of the branded product’s list price if there are three or more generic competitors, as there likely would be for such a lucrative market.
Ozempic’s Canadian list price is $218 for four weekly doses, which means generic copies should sell for $76 for a four-week supply before markups and dispensing fees. The list price in the United States is a little less than US$1,000, although, as Novo Nordisk, the drug’s Danish maker, points out, American diabetics with health insurance rarely pay that amount.
Novo Nordisk also makes a higher-dose version of semaglutide called Wegovy that is approved in Canada for weight loss and cardiovascular protection. The company announced last week that it was cutting the price of Wegovy for U.S. patients who pay out of pocket to US$499 a month. The list price for Wegovy in Canada is $388.64, according to Novo Nordisk.
It is more difficult to say how generic Ozempic may affect the bottom lines of provincial and territorial drug plans, which generally cover prescription medications for seniors, people with low incomes and patients who require very high-priced drugs.
New figures from the Canadian Institute for Health Information, set to be released Tuesday, show that overall spending by public drug plans hit $18.4-billion in 2023, a 6.7-per-cent increase over the year before. Much of that increase was driven by drugs for diabetes. Public spending on Ozempic rose to $662-million in 2023, up from $434-million in 2022.
“It’s the kind of exponential rise that is driving all of the increases in costs,” said Tracy Johnson, director of pharmaceuticals at CIHI.
However, CIHI’s figures don’t take into account the confidential discount deals that governments routinely sign with drug makers. The true prices provinces pay for brand-name drugs is a closely guarded secret.
Novo Nordisk’s patent for semaglutide in Canada expired in 2020, a spokesman for Health Canada confirmed. However, another route to market exclusivity for pharmaceuticals known as data protection does not expire in Ozempic’s case until January of next year.
The company’s Canadian branch declined an interview request. “Patent expiry is a natural part of a pharmaceutical product lifecycle and biosimilar and generic treatments may become available over time,” Kate Hanna, a spokeswoman for Novo Nordisk Canada, said in a statement.
Prof. Law said he expects that if generic Ozempic is approved in Canada, “there will be a lot of mail-order pharmacies [in Canada] that are going to get a lot of phone calls.”
In 2023, British Columbia restricted online sales of less-expensive Canadian semaglutide to foreigners after a dramatic spike in mail-order purchases from Americans. A Texas-based doctor had his Nova Scotia medical licence suspended after it was revealed he wrote thousands of Ozempic prescriptions, which were filled by a pair of Vancouver-area pharmacies, for U.S. patients.