Novo Nordisk legal win bars many compounded Wegovy, Ozempic drugs
Novo Nordisk Wins Legal Battle: Compounded Wegovy and Ozempic Drugs Restricted
In a landmark legal decision, Novo Nordisk has secured a significant victory that restricts compounding pharmacies from marketing or selling unapproved versions of its blockbuster weight loss drug Wegovy and diabetes treatment Ozempic.
Novo Nordisk headquarters in Bagsvaerd, Denmark (Image Credit: Mads Claus Rasmussen | AFP | Getty Images)
Federal Court Ruling Impacts Drug Access
A federal judge in Texas has rejected a bid by compounding pharmacies to continue manufacturing copies of Ozempic and Wegovy while a legal challenge over drug shortages unfolds. This decision comes in response to a February lawsuit from a compounding trade group against the Food and Drug Administration’s determination that the active ingredient in these drugs, semaglutide, is no longer in short supply in the U.S.
Key Implications of the Ruling
- FDA can now immediately target 503A pharmacies making compounded semaglutide
- 503B pharmacies face enforcement actions after May 22
- Patient access to compounded versions will be significantly reduced
- Novo Nordisk’s market position strengthened
Patient Safety and Market Impact
“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. The company has filed over 100 lawsuits against compounding pharmacies and other entities across 32 states to protect patient safety.
Regulatory Landscape and Future Implications
The ruling upholds the FDA’s authority to regulate compounded medications and sets a precedent for similar cases in the pharmaceutical industry. This decision follows another victory for Novo Nordisk against MediOak Pharmacy, which was permanently prohibited from marketing or selling compounded semaglutide.
Industry Response
Eli Lilly has pursued similar legal actions regarding tirzepatide, the active ingredient in its weight loss drug Zepbound and diabetes treatment Mounjaro. The FDA declared the U.S. shortage of tirzepatide over last year, leading to similar legal challenges from the compounding industry.
Looking Ahead
This legal victory for Novo Nordisk represents a significant shift in the pharmaceutical landscape, particularly for weight loss and diabetes treatments. The ruling emphasizes the importance of FDA-approved medications and patient safety while potentially limiting access to more affordable alternatives.
The decision may have far-reaching implications for the pharmaceutical industry, patient access to medications, and the future of compounded drugs in the United States.
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