In this article, Novo Nordisk has requested the Food and Drug Administration (FDA) to prevent compounding pharmacies from producing unapproved versions of its weight loss injection Wegovy and diabetes treatment Ozempic. Novo Nordisk argues that these medications are too complex for compounding pharmacies to safely manufacture. The FDA is yet to make a final decision on whether compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy, should be prohibited. The agency stated that it is reviewing the petition and will respond directly to Novo Nordisk.
Novo Nordisk has taken various actions to address potentially harmful copies of semaglutide, including filing 50 lawsuits against clinics, compounding pharmacies, and other manufacturers in the past year. This move comes as the company aims to increase the supply of semaglutide to meet the high demand in the U.S. Patients have turned to compounded versions of semaglutide due to intermittent shortages of the branded drugs, which are expensive. Many health plans do not cover semaglutide for weight loss, making compounded versions a more affordable option.
Compounded medications are custom-made alternatives to branded drugs tailored to meet specific patient needs. When a brand-name drug is in short supply, compounding pharmacies can produce copies if they meet FDA requirements. Semaglutide, the active ingredient in Wegovy and Ozempic, has experienced intermittent shortages over the past two years. Novo Nordisk has nominated semaglutide to the FDA’s “Demonstrable Difficulties for Compounding” list, indicating that compounders should not make complex drugs like semaglutide, even during shortages, due to safety concerns.
Novo Nordisk highlighted risks associated with compounded semaglutide, such as unknown impurities, incorrect dosage strengths, and instances where the product contained no semaglutide at all. The company emphasized the complexity of safely compounding these drugs and the potential risks to patient safety. Novo Nordisk aims to ensure that patients receive only FDA-approved, safe, and effective semaglutide products.
The FDA has previously cautioned against using compounded versions of GLP-1s like semaglutide, citing risks to patients as these drugs are unapproved. The agency has received reports of patients overdosing on compounded semaglutide due to errors in administration. Both Wegovy and Ozempic are protected by patents, and Novo Nordisk and Eli Lilly, the manufacturers, do not supply the active ingredients to external groups.
Eli Lilly’s weight loss injection Zepbound and diabetes treatment Mounjaro contain tirzepatide as the active ingredient. Like Novo Nordisk, Eli Lilly has taken legal action against weight loss clinics, medical spas, and compounding pharmacies in the U.S. The FDA recently removed tirzepatide from its shortage list after more than a year, despite some pharmacies still facing challenges in stocking the branded versions. A trade group representing compounders sued the FDA, prompting the agency to reconsider its decision regarding tirzepatide’s shortage status.
