Court Ruling Limits Ozempic Copies in Favor of FDA, Novo Nordisk

A Texas judge denied a motion from compounders to keep making versions of Ozempic and Wegovy, clearing the way for FDA enforcement and other lawsuits.

The injectable drug Ozempic in Houston on July 1, 2023. David J. Phillip/AP Photo

A federal court in Texas has ruled against a trade group representing compounding pharmacies, siding with the Food and Drug Administration (FDA) and pharmaceutical company Novo Nordisk in a dispute over copies of the popular weight-loss and diabetes drugs Ozempic and Wegovy.

The ruling, issued April 24 in the U.S. District Court for the Northern District of Texas, denied a request from the Outsourcing Facilities Association (OFA) to block the FDA’s recent decision to remove semaglutide from its drug shortage list.

That decision effectively ended a temporary allowance for pharmacies to compound semaglutide-based drugs for patients. Semaglutide is the active ingredient in Ozempic and Wegovy. Court documents remain sealed, but the outcome was confirmed by two related parties from a Novo Nordisk statement and an OFA statement.

According to a KFF study last year, one in eight adults say they have taken one of the drugs before, and as many as four in 10 of those who have been told by a doctor they have diabetes have taken it.

Without the shortage designation, pharmacies may no longer produce compounded versions of semaglutide except in rare circumstances. Smaller 503A pharmacies must stop immediately, while larger outsourcing facilities have until May 22 before facing FDA enforcement.

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

Several other lawsuits regarding another popular weight loss medication called tirzepatide [brand name Zepbound and Mounjaro] are also ongoing, as its manufacturer, Eli Lilly, has taken a similar legal approach as Novo Nordisk. The FDA declared that the drug’s shortage was resolved in December.

In an emailed statement to The Epoch Times on Friday, the Outsourcing Facilities Association said it was “deeply disappointed” by the court’s decision.

“The U.S. District Court for the Northern District of Texas misapprehended or failed to take into consideration the clear and convincing evidence that demonstrates that the manufactured supply of semaglutide is not able to meet the enormous demand in the U.S.,” said OFA Chairman Lee H. Rosebush.

“We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA. We will not stop in our efforts to ensure that patients can get access to this vital medication.”

Novo Nordisk said the ruling supports the FDA’s conclusion that the supply of its brand-name semaglutide products is sufficient to meet U.S. demand.

“The court’s ruling left in place FDA’s prior determination that all doses of Wegovy® and Ozempic® are fully available nationwide and that Novo Nordisk’s supply of these FDA-approved medicines is meeting or exceeding current and projected nationwide patient demand,” the company said in the statement.

“With the FDA’s resolution of the shortage of Ozempic® and Wegovy®, as left in place by this court ruling, it is illegal under U.S. compounding laws to make or sell knockoff ‘semaglutide drugs,’ with rare exceptions.”

The company said it has filed 111 lawsuits in federal courts across 32 states to stop the marketing and sale of what it describes as knockoff or misbranded compounded versions.

“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, Novo Nordisk’s general counsel.

“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. Patient safety remains a top priority for Novo Nordisk, and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate ‘semaglutide’ drugs are working.”

While brand-name drugs such as Ozempic and Wegovy can cost more than $1,000 per month without insurance, compounded versions have been sold at lower prices, often through telehealth providers. Critics argue that patients who can’t afford the brand-name medications may lose access if compounders are forced to stop.

Novo Nordisk says its legal efforts are aimed at protecting patients from unsafe or unregulated products, including those made with synthetic semaglutide from overseas suppliers, such as manufacturers in China that have not been reviewed by the FDA.

Novo Nordisk and the FDA did not respond to additional questions from The Epoch Times before publication time.