Novo Nordisk Wins Case Against Compounded Wegovy and Ozempic Drugs

Introduction to Novo Nordisk’s Legal Victory

Novo Nordisk scored a huge legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker’s blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to keep making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds.

Background of the Case

That came in response to a February lawsuit from a compounding trade group against the Food and Drug Administration’s determination that the active ingredient in those drugs, semaglutide, is no longer in shortage in the U.S. Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn’t have insurance coverage for the costly treatments.

FDA Regulations and Compounding Pharmacies

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth companies, such as Hims & Hers, also offered those copycats. But drugmakers and some health experts have pushed back against the practice because the FDA does not approve compounded drugs, which are essentially custom-made copies prescribed by a doctor to meet a specific patient’s needs.

Reaction from Novo Nordisk

"We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage" of semaglutide is resolved, said Steve Benz, Novo Nordisk’s corporate vice president, legal and U.S. general counsel, in a statement. "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," he said, referring to the company’s more than 100 lawsuits against compounding pharmacies and other entities across 32 states.

Court Decision

On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association’s bid for a preliminary injunction that would have prevented the FDA from taking action against its members for making copies of semaglutide. That decision upholds the FDA’s previous determination that the semaglutide shortage in the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient.

Impact of the Decision

Those pharmacies are largely regulated by states rather than the FDA. The decision also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency’s actions can include product seizures and warning letters to pharmacies.

Recent Developments

The decision on Thursday follows another win for Novo Nordisk. A different federal judge in Texas earlier this week ruled in favor of the drugmaker against a 503A pharmacy, MediOak Pharmacy, permanently prohibiting the business from marketing or selling compounded semaglutide. Novo Nordisk and Eli Lilly have aggressively cracked down on compounding pharmacies over the last two years as they benefit from the soaring popularity of their weight loss and diabetes drugs.

Conclusion

In conclusion, the recent court decision marks a significant victory for Novo Nordisk in its efforts to restrict compounding pharmacies from marketing or selling cheaper, unapproved versions of its blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. The decision upholds the FDA’s determination that the semaglutide shortage in the U.S. is over and allows the FDA to take action against compounding pharmacies that continue to make copies of the drug.

FAQs

Q: What is the significance of the court decision for Novo Nordisk?
A: The court decision marks a significant victory for Novo Nordisk in its efforts to restrict compounding pharmacies from marketing or selling cheaper, unapproved versions of its blockbuster weight loss drug Wegovy and diabetes treatment Ozempic.
Q: What is the FDA’s role in regulating compounding pharmacies?
A: The FDA regulates compounded drugs, but compounding pharmacies are largely regulated by states rather than the FDA.
Q: What is the impact of the decision on 503A and 503B pharmacies?
A: The decision allows the FDA to immediately go after 503A pharmacies that are making compounded versions of semaglutide according to individual prescriptions for a specific patient, and to start targeting federally regulated 503B pharmacies after May 22.
Q: How have Novo Nordisk and Eli Lilly responded to the practice of compounding pharmacies?
A: Novo Nordisk and Eli Lilly have aggressively cracked down on compounding pharmacies over the last two years as they benefit from the soaring popularity of their weight loss and diabetes drugs.