Novo Nordisk Let Canadian Ozempic Patent Extension Lapse: I-MAK

Novo Nordisk's patent on Ozempic in Canada could have been extended until 2028 but the company failed to renew it, according to Tahir Amin, CEO and founder of the Initiative for Medicines, Access & Knowledge (I-MAK), in comments to the BBC.

The missed extension

Amin told the BBC it is unclear why the Danish drugmaker did not pursue the extension, but said "somebody dropped the ball … that's why you've got generics in Canada sooner". The Canadian outcome contrasts with the United States, where Amin said Americans are not expected to see a generic version of semaglutide until 2032, when the main compound patent is set to expire.

In a statement to the BBC, Novo Nordisk described the arrival of generics in Canada as a "localized situation based on our specific patent timelines and regulatory environment" and said it does not reflect the U.S. situation, "where exclusivity remains intact".

A second $250 fee angle

The patent question sits alongside a separate regulatory fee issue previously reported by The BMJ, which noted that Canada became only the second country in the world to approve a generic form of semaglutide after Novo Nordisk did not pay a C$250 annual fee. Two generic versions of injectable semaglutide have since been approved by Health Canada – one from India's Dr. Reddy's Laboratories and one from Canadian manufacturer Apotex – with seven other applications still under review.

The Dr. Reddy's generic became available in Canada on May 15, according to The BMJ. Coverage of Ozempic and Wegovy pricing is tracked on GLP1Prices.ca, alongside Mounjaro and Zepbound.

Apotex eyes U.S. market

Apotex has secured a tentative approval from the U.S. Food and Drug Administration, though it cannot yet sell its generic semaglutide product there, the BBC reported. Martin Arès, CEO of Apotex, told the BBC he was exploring ways to bring the product to Americans now that it had received tentative FDA approval.

Arès said the product will not be on the U.S. market this year, adding: "But we remain committed to bringing this product as soon as possible". He said the company had experts working on identifying ways to make that happen.

Erez Israeli, CEO of Dr. Reddy's, told the BBC his company had applied for approval in more than 80 countries, including the U.S., and expects the generic to become available in South America, Africa and most of Asia, but not in the U.S., U.K. or Europe.

Novo Nordisk savings card response

In response to the arrival of generics, Novo Nordisk said starting Friday, eligible Canadians without public or private coverage would be able to buy Ozempic at a reduced price, "aligning their medication costs with generic alternatives". The savings card can be used at local pharmacies across Canada, excluding Quebec, and is applied automatically at Novo Nordisk Care Rx operated by Rexall.

Iain Graham, general manager at Novo Nordisk Canada, said: "We are dedicated to ensuring that eligible patients who choose Ozempic can stay on the brand because of these additional savings". Apotex has said its generic semaglutide will be approximately one-third the price of Novo Nordisk's brand-name Ozempic.

Context for Canadian buyers

Global News reported that Ozempic and Wegovy currently cost hundreds of dollars a month depending on dosage, in some cases more than $450. That figure sits within the current Canadian pharmacy price range tracked on GLP1Prices.ca. Readers can review pharmacy-level pricing on our Rybelsus page, the generic semaglutide tracker, the insurance coverage checker, and the FAQ.

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

Sources

• bbc.com
• bmj.com
• globalnews.ca