Canada in May became the first G7 country to approve a generic version of the blockbuster GLP-1 drug semaglutide, the active ingredient in Ozempic and Wegovy, creating a sharp pricing divide with the United States where patent protections are expected to block low-cost alternatives until 2032.
Health Canada has approved generic semaglutide injections from two manufacturers — India-based Dr Reddy’s Laboratories and Canadian drugmaker Apotex. The discounted medications are expected to be available in pharmacies across Canada as of June at less than a third of the brand-name price, according to the companies. The arrival of generics has already forced Novo Nordisk to lower prices on its brand-name Ozempic and Wegovy in Canada, patients and company officials told the BBC.
“Somebody dropped the ball” on renewing Novo Nordisk’s Canadian patent on Ozempic, which could have been extended until 2028, said Tahir Amin, CEO and founder of the Initiative for Medicines, Access & Knowledge (I-MAK), a US-based group that advocates for drug patent reform. Amin told the BBC it was unclear why the company failed to renew it, but the lapse opened the door for generic competition.
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.”
Erez Israeli, CEO of Dr Reddy’s, told the BBC that his company had applied for approval in more than 80 countries including the US. He said he expects the generic to be available soon in South America, Africa and most of Asia — but not in the US, the UK or Europe.
Apotex has secured “tentative approval” from the US Food and Drug Administration for its generic semaglutide but is not yet able to sell it in the US. Martin Arès, Apotex’s CEO, told the BBC the company was exploring ways to bring its product to Americans and had experts working on identifying a path forward, though he said it “definitely will not be on the US market this year.”
US and European countries allow pharmaceutical companies to extend patents for several years to compensate for regulatory delays, Amin explained. The main compound patent protecting semaglutide is not expected to expire until 2032 in the US, meaning American patients will not see a generic alternative until then, he said.
The pricing disparity is substantial. Uninsured Americans face costs upwards of $1,000 per month for Ozempic, according to the BBC report. More than 15 million American adults are estimated to take GLP-1 medications, a class that includes semaglutide as well as drugs from Eli Lilly and others.
For Canadians paying out of pocket, the generics represent a significant change. Elizabeth Doran, a 69-year-old retired Ottawa resident, told the BBC she was paying between C$350 and C$500 per month for Wegovy to reverse prediabetes and high blood pressure after being diagnosed as “one decimal point away from being diabetic.” She said she picked up substitute teaching shifts to afford the medication. With the generics, she said, she expects to maintain her weight loss at a fraction of the cost.
Esther Linetsky, another Canadian patient prescribed Ozempic for weight loss, told the BBC the high cost forced her to temporarily stop taking the drug and later ration free samples provided by her doctor. “My doctor wanted me to go up to the next dose, but going up to the next dose meant increasing my cost, and I couldn’t afford to do it,” she said. With generics available, she said she hoped to use the drug as intended and at a more affordable price.
The patent gap between Canada and the US has precedent for drawing American patients north. In 2019, a self-described “caravan” of Americans bused to Canada to purchase cheaper insulin for type 1 diabetes. In 2023, British Columbia restricted cross-border Ozempic purchases after finding 15% of the province’s prescriptions for the drug came from the US, mostly through Canada-based online pharmacies. Former provincial health minister Adrian Dix said at the time, “The purpose of procuring Ozempic for British Columbia patients is not to turn around and export it right back to the United States.”
Amin told the BBC he expected conversations were already underway among Americans about how to access low-cost generic Ozempic from Canada. He described changing the US patent system as an “uphill battle,” calling it the “Golden Egg” of the pharmaceutical industry, which he said had aggressively lobbied and litigated to maintain the status quo. He added that higher US prices meant GLP-1 drugs had mostly been accessed by wealthier Americans, leaving people who need the medication to manage diabetes unable to secure it.
Novo Nordisk recently took American online pharmacy Hims and Hers to court over selling compounded versions of semaglutide at lower cost, the BBC reported. The legal battle was dropped in March after the pharmacy agreed to stop advertising the compounds and sell semaglutide under the Ozempic and Wegovy brands. The company has also fought to extend its patents in China and Brazil.