Novo Nordisk has asked the FDA to add semaglutide to a list that would effectively block manufacturing of copycat versions of Wegovy and Ozempic.

Novo Nordisk wants the Food and Drug Administration (FDA) to prevent compounding pharmacies from manufacturing their own versions of the company’s popular weight loss drug Wegovy and diabetes treatment Ozempic,

The Danish drugmaker Novo Nordisk contends that semaglutide, the active ingredient in Ozempic and Wegovy, is too complex for those manufacturers to make safely.

Under US law, compounding pharmacies can make and sell patent-protected drugs that are on the FDA's shortages list in limited amounts, and have been reaping the rewards of supplying versions of Novo Nordisk's obesity drug Wegovy and Ozempic for diabetes, which are both based on the GLP-1 receptor agonist.

Oct 23 (Reuters) - Novo Nordisk (NOVOb.CO) on Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely.

Ozempic maker Novo Nordisk (NVO) is asking the U.S. Food and Drug Administration (FDA) to prohibit compounding pharmacies from making off-brand versions of semaglutide, the active ingredient in its blockbuster weight loss and diabetes medications.

The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable Difficulties for Compounding Lists."

Novo Nordisk is pushing the FDA to block compounders from making copies of its Ozempic and Wegovy, saying the weight-loss treatments are too complex to safely replicate. Why it matters: It's the latest twist in the battle between pharma giants and compounders over the law that allows copies of patent-protected drugs amid shortages.