Novo Nordisk (NVO, Financial), a Danish pharmaceutical company, is actively opposing the production of compounded semaglutide by pharmaceutical firms. The company has communicated to the U.S. Food and Drug Administration (FDA) that this drug is difficult to manufacture, and incorrect production methods could pose safety risks.
Novo Nordisk has requested the FDA to add semaglutide to a list of drugs that are challenging to synthesize. Their legal representatives, Covington & Burling, highlighted the complexity involved in the formulation, delivery mechanism, dosage form, bioavailability, compounding process, and chemical and analytical testing of semaglutide.
Semaglutide is the key ingredient in Novo Nordisk's popular weight-loss and Type 2 diabetes medications, Wegovy and Ozempic. Due to the popularity of their medications, Novo Nordisk's competitor, Eli Lilly, has faced shortages of its own drugs, Tizepatide for weight loss and Mounjaro for diabetes, throughout much of 2024, although these shortages have now been resolved.
If a drug is listed on the FDA's drug shortage list, compounded manufacturers can produce it even while it is still under patent protection. Eli Lilly recently took legal action against three companies that continued to manufacture and sell compounded Tizepatide.
