Apotex CEO Says US Launch of Generic Semaglutide Not in 2026

Apotex CEO Martin Arès told the BBC that the Canadian generic manufacturer's semaglutide product will not reach the United States market in 2026, even though the company has secured a tentative approval from the US Food and Drug Administration [Source: bbc.com/news/articles/c142y4p2eyxo].

Apotex confirms no 2026 US launch

Arès, chief executive of the Canadian pharmaceutical company Apotex, said his company was exploring ways to bring its generic semaglutide to American patients now that the product has been tentatively approved by the FDA [Source: bbc.com/news/articles/c142y4p2eyxo]. He said the product "definitely will not be on the US market this year" and that Apotex had experts working on identifying ways to make a US launch happen [Source: bbc.com/news/articles/c142y4p2eyxo].

Apotex began shipping its generic semaglutide in Canada in the weeks after Health Canada authorization, and the company has said its product will be priced at approximately one-third the price of Novo Nordisk's brand-name Ozempic [Source: globalnews.ca/news/11863331/novo-nordisk-slash-ozempic-price-generics/].

Dr Reddy's targeting 80-plus countries

Erez Israeli, chief executive of Dr Reddy's Laboratories, told the BBC that his company had applied for approval in more than 80 countries, including the United States [Source: bbc.com/news/articles/c142y4p2eyxo]. Israeli said Dr Reddy's generic GLP-1 is expected to become available in South America, Africa and most of Asia in addition to Canada, but not in the US, UK or Europe [Source: bbc.com/news/articles/c142y4p2eyxo].

Dr Reddy's generic semaglutide became available in Canada on May 15, 2026, according to reporting in The BMJ [Source: bmj.com/content/393/bmj-2026-597166]. The Canadian approval made Canada only the second country in the world to authorize a generic form of Ozempic [Source: bmj.com/content/393/bmj-2026-597166].

Patent commentary points to 2032 for US generics

Tahir Amin, chief executive and founder of the US-based Initiative for Medicines, Access & Knowledge (I-MAK), told the BBC that Americans would not see a generic semaglutide until 2032, when the main compound patent protecting the molecule is expected to expire in the United States [Source: bbc.com/news/articles/c142y4p2eyxo]. Amin said US and European countries allow companies to extend patents for several years as compensation for regulatory delays [Source: bbc.com/news/articles/c142y4p2eyxo].

Amin also said Novo Nordisk's patent on Ozempic could have been extended until 2028 in Canada but that the company failed to renew it [Source: bbc.com/news/articles/c142y4p2eyxo]. He said it was unclear why, adding that "somebody dropped the ball … that's why you've got generics in Canada sooner" [Source: bbc.com/news/articles/c142y4p2eyxo].

The Canadian approval was made possible after Novo Nordisk did not pay a C$250 annual fee, according to The BMJ [Source: bmj.com/content/393/bmj-2026-597166]. Novo Nordisk said in a statement to the BBC 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" [Source: bbc.com/news/articles/c142y4p2eyxo].

Cross-border interest anticipated

Amin told the BBC that conversations were likely already swirling among Americans about how they could access low-cost generic Ozempic from Canada [Source: bbc.com/news/articles/c142y4p2eyxo]. The BBC noted that in 2023, the province of British Columbia put restrictions on Americans purchasing its Ozempic after finding that 15% of prescriptions for the drug came from the US, mostly through Canada-based online pharmacies [Source: bbc.com/news/articles/c142y4p2eyxo].

Then-BC 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" [Source: bbc.com/news/articles/c142y4p2eyxo].

Canadian pricing context

Novo Nordisk said that starting the Friday following its announcement, eligible Canadians without public or private coverage would be able to buy Ozempic at a reduced price aligned with generic alternatives, using a Novo Nordisk Savings Card at pharmacies across Canada excluding Quebec, with automatic application at Novo Nordisk Care Rx operated by Rexall [Source: globalnews.ca/news/11863331/novo-nordisk-slash-ozempic-price-generics/]. Iain Graham, general manager at Novo Nordisk Canada, said the company was dedicated to ensuring eligible patients who choose Ozempic can stay on the brand [Source: globalnews.ca/news/11863331/novo-nordisk-slash-ozempic-price-generics/].

Canadian shoppers comparing options can review current listings for Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound, use the insurance coverage checker, follow the generic semaglutide tracker, or consult the FAQ.

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