The flag of the Danish drug maker logo will present the flag of Novo Nordisk, the manufacturer of blockbuster diabetes and weight loss treatments, and the annual report will be presented at Novo Nordisk in Bucksveld, Denmark on 5 February 2025, and the annual report at Bucksveld, Denmark on 5 February 2025.
Mads Klaus Rasmussen | AFP | Getty Images
Novo Nordisk From drugmakers’ big hit weight loss drug Wegovy and diabetes treatment Ozempic marketing or selling cheaper and less approved versions, they won a big legal victory that largely limits the dispensaries to formulate.
A federal judge in Texas refused a bid late Thursday for consolidating pharmacies and continuing to produce copies of Ozenpic and Wegovi, but the legal challenges for these drug shortages unfolded. It came in response to a February lawsuit from the compounding trade group, contrary to the Food and Drug Administration’s decision that semaglutide, the active ingredient in these drugs, is no longer in the US.
Patients flocked to cheaper copycats when Ozempic and Wegovy were short on the past two years due to spikes in demand or lack of insurance coverage for expensive treatments.
During the shortages occupying the FDA, pharmacists can legally create compound versions of branded drugs. Many telehealth companies such as Hims & Hersalso provided imitations of them. However, drug makers and some medical professionals opposed the practice because the FDA does not approve combined drugs, custom-made copies set by doctors to meet the needs of specific patients.
“We are pleased that the court has rejected Compargies’ attempt to undermine the FDA’s database’s decision to resolve the semaglutide shortage,” Steve Benz, vice president of law and corporate vice president of Nord Nordisk, said in a statement.
“Patient safety is Novo Nordisk’s number one priority, and the widespread nationwide legal action we have taken to protect Americans from the health risks posed by illegal “semaglutide” drugs is working,” he said, referring to the company’s more than 100 lawsuits against 32 states’ combined pharmacies and other entities.
On Thursday, US District Judge Mark Pittman specifically denied the Outsourcing Facility Association’s interim injunction bid that would have prevented the FDA from taking action against its members to make copies of Semaglutide.
That decision supports the FDA’s previous decision that the US semaglutide deficiency has ended, meaning that the FDA can quickly kick out the so-called 503A pharmacies making composite versions of semaglutide according to the individual prescriptions of a particular patient.
These pharmacies are primarily regulated by the state, not the FDA.
The decision also means that the FDA can begin targeting federal regulatory 503B pharmacies from May 22nd that produce complex drugs in large quantities with or without prescription. Agency actions can include product seizures and warning letters to the pharmacy.
Thursday’s decision follows another victory for Novo Nordisk. Earlier this week, another federal judge in Texas favored drugmakers against Medioak Pharmacy, a 503A pharmacy, and permanently banned the marketing or sale of their business.
Novo Nordisk and Eli Lily Over the past two years, they have been actively cracking down on combined pharmacies to benefit from weight loss and the growing popularity of diabetes medications.
Eli Lily went through a similar legal process to Tilzepatide, the active ingredient in weight loss drug Zepbound and diabetes treatment Munjaro. The FDA declared a shortage of US tilzepatide last year, urging that the same combined trade group should sue the FDA via drugs.
In March, a federal judge rejected a combined group’s request for preliminary injunctions regarding FDA enforcement against members to make copies of Mounjaro and Zepbound. The combined group sued.
