Stocktwits - Novo Nordisk (CSE:NOVOb) (NVO) announced on Friday that it has secured a legal victory against compounders selling unauthorized versions of the company’s Wegovy and Ozempic drugs.
A Texas federal court denied a compounding trade association’s bid to freeze the U.S. Food and Drug Administration’s decision to halt the compounding of semaglutide, the active ingredient in Wegovy and Ozempic, on Thursday.
Compounders are allowed to produce copies of drugs only when they are declared to be in short supply by the FDA. In February, the FDA announced that the semaglutide injection product shortage had been resolved, preventing compounders from manufacturing copies of Wegovy and Ozempic.
The compounding trade association subsequently approached the court requesting a freeze on the FDA’s decision.
Semaglutide injection products were first added to the FDA’s drug shortage list in March 2022 for Wegovy and August 2022 for Ozempic, paving the way for compounders to replicate them.
Steve Benz, legal and US general counsel of Novo Nordisk, stated the company is “pleased” that the court rejected the compounders’ attempts to “undermine” the FDA’s decision that the shortages of Wegovy and Ozempic have been resolved.
"FDA’s determination was based on a thorough review of Novo Nordisk’s stable and growing supply of these important FDA-approved medicines. With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic ’semaglutide’ drugs,” he said.
He also added that the nationwide legal actions taken by the company against compounders are “working.”
“We will continue driving these actions forward and escalate our efforts as necessary, while closely engaging with regulators and law enforcement," he said.
Novo Nordisk has filed 111 lawsuits in federal courts across 32 states against entities that have unlawfully marketed and sold compounded semaglutide to date.
With the court ruling in favor of FDA’s determination that the semaglutide shortage in the U.S. is over, FDA may immediately take action against pharmacies compounding versions of Novo Nordisk’s FDA-approved semaglutide medicines, the company said.
Outsourcing facilities can continue to compound semaglutide injectable drugs until May 22, after which date the FDA may take action against them.
Recently, a separate federal court ruled in favor of Novo Nordisk against MediOak Pharmacy LLC, permanently prohibiting them from marketing or selling compounded "semaglutide" knockoff drugs.
On Stocktwits, retail sentiment around Novo Nordisk fell from ‘extremely bullish’ to ‘bullish’ territory over the past 24 hours while message volume dropped from ‘high’ to ‘normal’ levels.
NVO’s Sentiment Meter and Message Volume as of 1:00 p.m. ET on April 25, 2025 | Source: StocktwitsNVO stock is down by over 29% so far this year and by about 51% over the past 12 months.
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