Novo Nordisk Legal Win Bars Many reinforced Wortovy, Ozempische Drugs
Flags with the logos of the Danish drug maker Novo Nordisk, manufacturer of the blockbuster diabetes and weight loss treatments Ozempic and Wegovy are pictures, while the company introduces the annual report at Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.
Mads Claus Rasmussen | AFP | Getty pictures
Novo Nordisk achieved a great legal victory in which the mediation of pharmacies by marketing or selling cheaper, non -approved versions of the blockbuster weight loss drug for active ingredients and diabetes treatment Ozempic.
A federal judge in Texas late Thursday declined an offer by putting pharmacies together to continue to make copies of Ozempic and Wegovy, while a legal challenge for the lack of these medication unfolds. This came in response to a lawsuit in February of a compound trading group against the determination of the Food and Drug Administration that the active ingredient in these medication, Semaglutide, is no longer poor in the USA
The patients flocked to the cheaper imitators when Ozempic and Wegovy were poor in the past two years due to the increasing demand or if they had no insurance cover for the costly treatments.
In the case of FDA-declaring lack of pharmacists, pharmacists can legally produce versions of branded medication. Many telemedicine companies like Hims & Heinalso offer these imitators. However, drug manufacturers and some health experts are committed to the practice, since the FDA does not agree with increased medication that are essentially tailor -made copies that are prescribed by a doctor to meet the needs of a specific patient.
“We are pleased that the court has rejected the attempts at the connections to undermine the FDA's data-based decision that the deficiency” des Semaglutids “has” solved “, said Steve Benz, Corporate Vice President of Nordisks Corporate Vice, Legal and US General Counsel.
“For Novo Nordisk, patient safety is still a top priority and the extensive nationwide legal measures that we have taken to protect the Americans from the health risks by illegitimate 'Semaglutide' medication,” he was based on the more than 100 complaints from the company against the integration of pharmacies and other ideas in 32 states.
On Thursday, the US district judge Mark Pittman expressly attended the offer of the Outsourcing Facilities Association for an injunction that would have prevented the FDA from taking measures against its members to make copies of Semaglutid.
This decision keeps the earlier determination of the FDA that the semaglutide deficiency in the United States is over and means that the FDA can now immediately pursue according to so-called 503a pharmacies, which according to the individual prescriptions for a certain patient produce versions of Semaglutide.
These pharmacies are largely regulated by states as the FDA.
The decision also means that the FDA can start with the focus on Föderal -regulated 503b pharmacies, which after May 22nd produces increased medicines in large quantities with or without recipes. The agency's measures can include product attacks and warning letters to pharmacies.
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The decision on Thursday will follow another victory for Novo Nordisk. Another federal judge in Texas decided at the beginning of this week in favor of the drug maker against a pharmacy of 503a, Medioak Pharmacy, and permanently prohibited the business from marketing or selling Semaglutid.
Novo Nordisk and Eli Lilly have summarized compounding pharmacies aggressively in the past two years because they benefit from the increasing popularity of their weight loss and their diabetes medication.
Eli Lilly has undergone a similar legal process with Tirepatide, the active ingredient in its weight loss medication zepound and diabetes treatment Mounjaro. The FDA explained the US deficiency in Tirzatide last year and prompted the same composite trading group to sue the FDA via the medication.
In March, a federal judge denied the application of the Compounding Group at an injunction when enforcing the FDA against its members because they made copies of Mounjaro and Zepbound. The Compounding Group has appealed.
