Novo Nordisk (NVO.US) pressures FDA to limit semaglutide generics, asks to be added to the list of difficult-to-make drugs
1min read Zhitong Finance APP noticed that Novo Nordisk (NVO.US) has been trying to crack down on compound pharmacies that produce semaglutide, and has told the US Food and Drug Administration that the drug is difficult to produce and could pose safety risks if not produced properly.
The Danish pharmaceutical company has asked the FDA to add semaglutide to its list of drugs that are difficult to prove.
Novo Nordisk's lawyer Covington & Burling wrote in a document: "Semaglutide products are on these lists due to their formulation, delivery mechanism, dosage form, bioavailability, complex compounding process, and physical and chemical and analytical testing."
Semaglutide is the active ingredient in Novo Nordisk's blockbuster weight loss and type 2 diabetes drugs Wegovy and Ozempic.
Novo Nordisk's competitors Eli Lilly and Company produce Tizepatide for weight loss and Mounjaro for diabetes, and both drugs were in short supply for most of 2024 due to their popularity. However, those drugs are no longer in short supply.
If on the FDA's drug shortage list, compound manufacturers can produce drugs that are still under patent protection.
Lilly recently sued three companies that continue to produce and sell compounded Tizepatide.
