Ozempic Maker Tries to Ban Compounded Versions of Its Blockbuster Drug

Drugmaker Novo Nordisk is moving to crack down on the industry’s most popular generic semaglutide, which offers copies of its weight-loss drugs Ozempic and Wegovy to patients—often at much lower prices.

A Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) list, which would prevent compounding pharmacies from producing drug dupes. In a filing sent by the agency on Tuesday, Novo Nordisk’s lawyers said semaglutide is off the list “because of the complexity associated with its formulation,” among other reasons.

“These drugs are inherently complex to combine safely, and the risks to patient safety far outweigh any benefits. “Novo Nordisk’s goal with this designation is to ensure that patients receive only an FDA-approved, safe, and effective semaglutide product,” said Novo Nordisk director of media relations Jamie Bennett.

FDA press officer Amanda Hils told WIRED via email that the agency is “reviewing the request and will respond directly to the requester.”

If approved, the word would have a seismic impact on the compounding industry—and on the millions who may be taking GLP-1 compounded drugs right now.

Injectable GLP-1 drugs including semaglutide and tirzepatide have been in short supply since 2022 due to their huge popularity. In the US, when the FDA declares that a drug is in short supply, certain licensed pharmacies are allowed to make “compounded” versions of drugs, mixed in-house and which must contain the same active ingredients as the original drug.

Telehealth providers have used GLP-1 deficiency drugs, offering patients compounded versions through quick virtual appointments. This trend has created tension among the pharmaceutical companies that make these brand name drugs as the compounded versions are sold at very low prices. Ozempic and Wegovy can cost about $1,000 a month without insurance, while combined semaglutide is advertised for as little as $100 a month online.

Unlike generic drugs, which are produced after the drugs’ patents expire, compounded drugs are not subject to FDA approval before entering the market. This means that the FDA cannot prove the safety, efficacy, or quality of compounded drugs before they are sold to patients. The FDA has received numerous reports of serious adverse effects, including hospitalizations, related to possible dosing errors associated with combination semaglutide products.