Court Decision Restricts Ozempic Generics in Support of FDA and Novo Nordisk

April 26, 2025 TruthUSA

A Texas judge has rejected a motion from compounders, allowing the FDA to proceed with enforcement actions and lawsuits against them related to Ozempic and Wegovy.

A Texas federal court has ruled against a trade association for compounding pharmacies, backing the FDA and Novo Nordisk in a case concerning replicas of the widely used weight-loss and diabetes medications, Ozempic and Wegovy.

The ruling, made on April 24 by the U.S. District Court for the Northern District of Texas, declined a request from the Outsourcing Facilities Association (OFA) to prevent the FDA’s recent decision to remove semaglutide from its drug shortage roster.

This decision effectively terminated a temporary allowance that permitted pharmacies to compound medications based on semaglutide. Semaglutide serves as the active ingredient in both Ozempic and Wegovy. While court documents are sealed, the outcome has been confirmed by statements from both Novo Nordisk and the OFA.

According to a KFF study conducted last year, one in eight adults reported having taken one of these medications, with nearly four in ten individuals diagnosed with diabetes having used it.

With the removal of the shortage designation, pharmacies are restricted from producing compounded versions of semaglutide, save for rare circumstances. Smaller 503A pharmacies must cease operations immediately, whereas larger outsourcing facilities have until May 22 to comply before facing FDA enforcement.

The FDA announced in February that it had “determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved,” stating that the shortage had begun in 2022 due to “increased demand.”

Multiple additional lawsuits involving another well-known weight-loss drug, tirzepatide (marketed as Zepbound and Mounjaro), are also in progress, as its producer, Eli Lilly, has adopted a similar legal strategy to Novo Nordisk. The FDA has declared that the shortage of this medication was resolved in December.

In a statement emailed to The Epoch Times on Friday, the Outsourcing Facilities Association expressed their “deep disappointment” regarding the judge’s ruling.

“The U.S. District Court for the Northern District of Texas misunderstood or overlooked the clear evidence showing that the manufactured supply of semaglutide cannot meet the high demand in the U.S.,” said OFA Chairman Lee H. Rosebush.

“We anticipate the chance to present this evidence again through legal channels and discussions with the FDA. We will persist in our efforts to ensure that patients have access to this crucial medication.”

Novo Nordisk responded by stating that the ruling reinforces the FDA’s finding that the supply of its brand-name semaglutide products adequately meets U.S. demand.

“The court’s decision upheld the FDA’s previous determination that all dosages of Wegovy® and Ozempic® are abundantly available nationwide and that Novo Nordisk’s supply of these FDA-approved medications is satisfying or surpassing current and projected nationwide patient needs,” the company explained.

“With the FDA’s resolution of the shortage of Ozempic® and Wegovy®, as affirmed by this court ruling, it is unlawful under U.S. compounding laws to create or distribute counterfeit ‘semaglutide drugs,’ except in rare cases.”

The company highlighted that it has initiated 111 lawsuits across 32 states to halt the marketing and distribution of what it terms knockoff or misbranded compounded versions.

“We are pleased that the court has dismissed the compounders’ attempts to challenge the FDA’s data-driven conclusion that the shortage of Wegovy® and Ozempic® has been resolved,” remarked Steve Benz, Novo Nordisk’s general counsel.

“The FDA’s conclusion was based on an exhaustive evaluation of Novo Nordisk’s stable and expanding supply of these essential FDA-approved medications. With the shortage of Wegovy® and Ozempic® now over, no patient should face exposure to unsafe, unverified ‘semaglutide’ medications. Patient safety remains our top priority, and our extensive legal actions to shield Americans from the dangers posed by illegitimate ‘semaglutide’ drugs are effective.”

While brand-name drugs like Ozempic and Wegovy can exceed $1,000 per month without insurance, compounded alternatives have often been sold at lower rates, primarily through telehealth services. Critics argue that patients unable to afford brand-name options may lose access if compounders are compelled to discontinue their offerings.

Novo Nordisk emphasizes that its legal actions are intended to safeguard patients from unsafe or unregulated products, particularly those manufactured with synthetic semaglutide from unverified overseas suppliers, including manufacturers in China lacking FDA review.

Neither Novo Nordisk nor the FDA responded to further inquiries from The Epoch Times prior to publication.

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