Novo Nordisk Wins Legal Battle To Curb Unsafe Knockoff Versions Of Ozempic, Wegovy

A federal court in Texas ruled in favor of Novo Nordisk A/S (NYSE:NVO) and the U.S. Food and Drug Administration (FDA), rejecting an attempt by a compounding pharmacy trade group to halt the FDA’s decision declaring that there is no longer a shortage of semaglutide injectable drugs.

In February, the compounding groups filed a lawsuit challenging the FDA’s decision to remove semaglutide from the drug shortage list.

The plaintiffs argue that this action was arbitrary, unlawful, and detrimental to patients who rely on compounded semaglutide for type 2 diabetes, obesity, and cardiovascular disease.

Also Read: Counterfeit Ozempic Identified in US Supply Chain With Fake Labels And Needles, FDA Alerts

The ruling reinforces the FDA’s position that Novo Nordisk’s Ozempic and Wegovy supplies meet or exceed national demand.

Following the court’s decision, the FDA is now authorized to take enforcement action against 503A pharmacies that continue to compound unauthorized versions of semaglutide drugs.

Additionally, the ruling sets May 22, 2025, as the deadline for 503B outsourcing facilities to stop producing compounded semaglutide injectables.

“We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage of Wegovy and Ozempic is resolved,” said Steve Benz, Corporate Vice President, Legal and US General Counsel, Novo Nordisk.

“With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic ‘semaglutide’ drugs,” Benz added.

The ruling also addresses growing concerns about compounded semaglutide products made using synthetic active pharmaceutical ingredients (APIs) imported overseas.

A Brookings Institute report warned that some Chinese manufacturers supplying these APIs operate without FDA inspection or compliance with good manufacturing practices.

The report identified six Chinese firms responsible for 65% of the semaglutide imported into the U.S. between March 2023 and September 2024—three of which have never been inspected and three others cited for violations.

Novo Nordisk has been aggressively pursuing legal action nationwide, filing 111 federal lawsuits in 32 states against entities selling unauthorized semaglutide.

Some compounded products contained high impurity levels—up to 33%—or lacked semaglutide altogether.

Courts have issued injunctions against numerous pharmacies and marketers, with some judgments exceeding $8 million.

The Federal Bureau of Investigation also recently warned the public about safety concerns related to fraudulent compounding practices associated with weight loss drugs, warning that “[s]ome healthcare providers are using compounded mixtures of unknown drugs that do not contain semaglutide, drugs with high levels of impurities, and unsafe or unapproved drugs.”

Price Action: NVO stock is down 1.23% at $61.86 at the last check Friday.

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