Editor’s Note: This story has been updated to include comments from a Novo Nordisk spokesperson

Danish pharma giant Novo Nordisk A/S (NYSE:NVO) faces potential financial losses related to its blockbuster weight-loss and diabetes drug, Ozempic, due to a regulatory issue.

What Happened: About a week ago, Sandoz Group AG (OTC:SDZNY) CEO Richard Saynor, in an interview with EndPoint News, highlighted an administrative misstep by Novo in Canada that could have major ramifications for the Denmark-based company.

According to Saynor, “Novo never filed a patent in Canada,” and he says he has no idea why, since “It's the second-largest semaglutide market in the world,” which is the name of the compound that is sold under the brand names Ozempic, Rybelsus, and Wegovy.

Discussing the debacle, Saynor believes “someone's lost their job” over it, since there is the longstanding issue of Americans purchasing prescription drugs from Canada at lower prices, especially hormones such as Insulin.

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“There's clearly a dynamic, like insulin, with cross-border business. It's going to be interesting to see how that evolves,” he said.

According to the Canadian Patent Database, patent number CA-2601784 concerning Novo Nordisk’s GLP-1 compounds is currently “expired and beyond the Period of Reversal,” following multiple failures to make the payment, resulting in late fees that eventually amounted to $450.

“It's inaccurate to state that the reason generic competitors can launch in Canada next year is due to a mistake concerning payment of a maintenance fee,” said a Novo Nordisk spokesperson.

“All intellectual property decisions are carefully considered at a global level. Periods of exclusivity for pharmaceutical products end as part of their normal lifecycle and generic treatments may become available over time.”

The spokesperson told Benzinga that “no Health Canada-approved generic versions of semaglutide exist.”

Why It Matters: The launch of GLP-1 drugs by Novo Nordisk have had a big impact on the health, fitness and weight loss industries, even pushing the likes of weight-loss industry pioneer WW International Inc. (OTC:WGHTQ) into bankruptcy in recent weeks.

However, the company itself has since been hit with a series of setbacks, starting with President Donald Trump’s decision to ensure drug pricing in the U.S. is at par with those of the lowest priced nations.

Price Action: Shares of Novo were down 1.51% on Friday, trading at $79.83, and are up 0.45% after hours.

Novo Nordisk stock scores are all over the place in Benzinga’s Edge Stock Rankings, but it has a favorable price trend in the short and medium terms. You can find deeper insights into the stock, its peers and competitors here.

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