Novo Nordisk, the pharmaceutical company behind the popular diabetes and weight-loss drugs Ozempic and Wegovy, is actively working to limit compounded versions of these medications in the U.S. The company has petitioned the FDA to add semaglutide, Ozempic’s active ingredient, to the Demonstrably Difficult to Compound (DDC) list. If granted, this designation would bar compounding pharmacies from producing generic-like versions, effectively pushing patients toward FDA-approved products.
Novo Nordisk argues that the complexities involved in compounding semaglutide safely justify their request, citing patient safety concerns as the primary reason. Jamie Bennett, Novo Nordisk’s director of media relations, stressed that compounded versions of semaglutide carry risks of adverse effects due to dosing inconsistencies and quality issues. Although compounded drugs can legally bypass FDA approval when specific criteria are met—such as during drug shortages—the FDA has received reports of side effects associated with compounded semaglutide products.
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The backdrop of this move is a broader tension between pharmaceutical companies and the compounding industry, particularly as telehealth providers capitalize on the high demand for GLP-1 drugs like Ozempic. Telehealth clinics and pharmacies often offer compounded versions at a fraction of the price, sometimes as low as $100 monthly compared to the brand-name cost of around $1,000. This market competition has prompted Novo Nordisk to file numerous lawsuits against companies selling compounded alternatives, alleging unfair competition and trademark infringement.
Novo Nordisk is not alone in this push to limit compounded alternatives. Following a similar pattern, Eli Lilly, the producer of tirzepatide (marketed as Mounjaro and Zepbound), also took action recently when the FDA initially declared a resolution to the drug’s shortage, leading to a halt in compounded tirzepatide production. However, this decision was met with resistance, and the FDA is now reassessing tirzepatide’s shortage status, allowing limited compounding to resume.
With semaglutide still listed as in shortage, the compounding industry continues to offer compounded alternatives. However, should this shortage end, compounding pharmacies may find themselves barred from producing these high-demand drugs, heightening the battle between brand-name pharmaceutical giants and independent compounding businesses.
