Generic Ozempic by two manufacturers has already been approved by Health Canada – one by India-based pharmaceutical company Dr Reddy’s and another by Canadian company Apotex.
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. In addition to Canada, he expects Dr Reddy’s generic GLP-1 will soon be available in South America, Africa and most of Asia – but not in the US, UK or Europe.
Meanwhile, Apotex has secured a tentative approval by the US Food and Drug Administration (FDA), though it is not able to sell its generic semaglutide drug there yet.
US and European countries allow for companies to extend their patents for several years as a way to compensate them for regulatory delays, explained Tahir Amin, CEO and founder of US-based group the Initiative for Medicines, Access & Knowledge (I-MAK), which advocates for drug patent reform.
Amin said Americans would not see a generic until 2032, when the main compound patent protecting semaglutide is expected to expire.
Novo Nordisk’s patent on Ozempic could have been extended until 2028 in Canada but the company failed to renew it, Amin said. It is unclear why, he added, but “somebody dropped the ball … that’s why you’ve got generics in Canada sooner”.
Novo Nordisk said in a statement that the introduction 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”.
Amin said there were likely conversations already swirling among Americans on how they could access low-cost generic Ozempic from Canada.
It wouldn’t be the first time Americans sought access to lower cost drugs north of the border. In 2019, a self-described “caravan” of Americans bused to Canada to purchase cheaper insulin for type 1 diabetes – and to protest the costs in the US for the life-saving medication.
In 2023, the province of British Columbia put restrictions on Americans purchasing its Ozempic after it found that 15% of prescriptions for the drug came from the US, mostly through Canada-based online pharmacies.
The practice was condemned by the former provincial health minister 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,” said then-health minister Adrian Dix.