The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug

Drugmaker Novo Nordisk is taking enactment to curb the massively fashionable compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for overmuch little prices.

The Danish pharmaceutical institution is lobbying the US Food and Drug Administration to adhd semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) lists, which would artifact compounding pharmacies from producing dupes of the drug. In a filing posted by the bureau connected Tuesday, lawyers for Novo Nordisk crushed that semaglutide belongs connected the these lists “due to the complexities associated with their formulations,” among different reasons.

“These drugs are inherently analyzable to compound safely, and the risks they airs to diligent information acold outweigh immoderate benefits. Novo Nordisk’s purpose with this information is to guarantee that patients person lone FDA-approved, safe, and effectual semaglutide product,” says Novo Nordisk manager of media relations Jamie Bennett.

FDA property serviceman Amanda Hils told WIRED via email that the bureau “is reviewing the petition and volition respond straight to the petitioner.”

If granted, the designation would person seismic implications for the compounding industry—and for the apt millions of radical presently taking compounded GLP-1 drugs.

Injectable GLP-1 drugs including semaglutide and tirzepatide person been successful shortage since 2022 due to the fact that of their huge popularity. In the US, erstwhile the FDA declares that a cause is successful shortage, definite licensed pharmacies are permitted to marque “compounded” versions of the medication, which are mixed in-house and are expected to incorporate the aforesaid progressive ingredients arsenic the archetypal drug.

Telehealth providers person capitalized connected the GLP-1 cause shortage, offering patients compounded versions via quick virtual appointments. The signifier has created hostility with the pharmaceutical companies that marque the brand-name drugs since the compounded versions are sold astatine overmuch little prices. Ozempic and Wegovy tin outgo astir $1,000 a period without insurance, portion compounded semaglutide is advertised for arsenic debased arsenic $100 a period online.

Unlike generic medications, which are manufactured aft cause patents expire, compounded medications are not taxable to FDA support earlier hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, oregon prime of compounded drugs earlier they’re sold to patients. The FDA has received multiple reports of adverse broadside effects, including hospitalization, related to imaginable dosing errors associated with compounded semaglutide products.