Novo Nordisk has successfully halted the sale of compounded, unapproved versions of its popular drugs Ozempic and Wegovy, marking a crucial step in protecting its intellectual property and ensuring patient safety. A Texas federal court ruling has backed the company’s efforts to prevent compounding pharmacies from selling cheaper knockoffs of semaglutide, the active ingredient in these weight-loss and diabetes treatments.
This ruling supports the U.S. Food and Drug Administration’s (FDA) stance that the shortage of semaglutide in the U.S. has officially ended, allowing the FDA to take further action against pharmacies that continue to offer compounded versions. Compounded drugs, although sometimes used to meet specific patient needs, are not FDA-approved and can pose significant health risks.
Novo Nordisk’s legal team has emphasized that the decision protects patients from potential dangers associated with these unregulated alternatives, citing their ongoing commitment to patient safety. The company has pursued legal action against over 100 compounding pharmacies and related entities across 32 states, making this a major victory in the fight against illegal drug sales.
While the court ruling primarily impacts 503B pharmacies—which make compounded drugs in bulk—the 503A pharmacies, which prepare compounded drugs for individual prescriptions, may still legally produce semaglutide versions that are not identical to the branded products. However, these pharmacies are under scrutiny as the FDA moves to tighten enforcement.
The ruling comes amid a surge in demand for drugs like Ozempic and Wegovy, which have become highly sought-after due to their effectiveness in weight management and diabetes control. However, their rising popularity has led to a market for unapproved alternatives, which Novo Nordisk and other pharmaceutical giants like Eli Lilly have actively worked to curb.
This decision is a victory for Novo Nordisk as it fights to maintain its market share in the competitive weight-loss and diabetes treatment sectors. The company is expected to continue its aggressive legal efforts to block unauthorized semaglutide products and ensure that patients have access to safe, FDA-approved medications.