The flags with the logos of the Danish drug manufacturer Novo Nordisk, manufacturer of the successful diabetes and the weight loss treatments Ozempic and Wogovy are images, while the company presents the annual report in Novo Nordisk in Bagsvaerd, Denmark, on February 5, 2025.
Mads Claus Rasmussen | AFP | Getty images
Novo Nordisk It obtained a great legal victory that largely restricts the marketing compound pharmacies or the sale of cheaper and unveiled versions of the successful medicine to lose weight of the Ozempic drug addict.
A federal judge in Texas on Thursday night rejected an offer by aggravating pharmacies to continue making copies of Ozempic and Wogovy, while a legal challenge about the shortage of those drugs is developed. That came in response to a February demand from a commercial group composed of the determination of food and medicines administration that the active ingredient in those drugs, Semaglutide, is no longer scarcity in the United States.
The patients mass the cheapest imitators when Ozempic and Wogovy were scarce in the last two years due to the demand triggered, or if they did not have insurance coverage for expensive treatments.
During FDA's shortage, pharmacists can legally make compound versions of brand medications. Many Telesalud companies, such as Hims and hersHe also offered those imitators. But drug manufacturers and some health experts have rejected the practice because the FDA does not approve compound medications, which are essentially tailored copies by a doctor to meet the needs of a specific patient.
“We are happy that the Court has rejected the attempts of the compounds of undermining the decision based on FDA data that the scarcity of Semaglutida is resolved, said Steve Benz, the corporate vice president of Novo Nordisk, general legal advisor and the United States, in a statement.
“Patient safety remains a priority for Novo Nordisk and the extensive national legal actions that we have taken to protect Americans from the health risks raised by illegitimate drugs of 'Semaglutida' are working,” he said, referring to the more than 100 demands of the company against pharmacies and other entities in 32 states.
On Thursday, the United States District Judge, Mark Pittman, specifically denied the offer of the Association of Outsourcing Facilities for a preliminary court order that would have prevented the FDA from taking measures against its members for making copies of Semaglutide.
This decision defends the previous determination of the FDA that the scarcity of semaglutidas in the US. UU. It has ended and means that the FDA can now go immediately after the so -called 503a pharmacies that are making versions composed of semaglutida according to the individual prescriptions for a specific patient.
These pharmacies are largely regulated by states instead of the FDA.
The decision also means that the FDA can begin to go to Pharmacies 503B regulated by the federal government, which manufacture bulk compound medications with or without recipes, after May 22. Agency's actions may include seizures of products and warning letters to pharmacies.
Thursday's decision follows another victory for Novo Nordisk. A different federal judge in Texas earlier this week failed in favor of the drug manufacturer against a 503A pharmacy, Pharmacy Mediak, permanently prohibiting the marketing business or sale of compound semaglutida.
Novo Nordisk and Eli Lilly They have taken energetic measures aggressively in compound pharmacies in the last two years, since they benefit from the very high popularity of their weight loss and diabetes medications.
Eli Lilly has gone through a similar legal process with Tirzepaturo, the active ingredient in its medication to lose weight at zero and treatment of Mounjaro diabetes. The FDA declared the American shortage of Tirzepatide during the last year, which led to the same commercial group composed to demand the FDA for the drug.
In March, a federal judge denied the application of the group composed of a preliminary court order on the application of the FDA against its members for making copies of Mounjaro and Zepbound. The compound group has appealed.
