The Maker of Ozempic Is Trying to Block Compounded Versions of Its Blockbuster Drug
Drugmaker Novo Nordisk is taking action to curb the massively popular compounded semaglutide industry, which provides copies of its blockbuster weight-loss drugs Ozempic and Wegovy to patients—often for much lower prices.
The Danish pharmaceutical company is lobbying the US Food and Drug Administration to add semaglutide to the agency’s Demonstrable Difficulties for Compounding (DDC) lists, which would block compounding pharmacies from producing dupes of the drug. In a filing posted by the agency on Tuesday, lawyers for Novo Nordisk reason that semaglutide belongs on these lists “due to the complexities associated with their formulations,” among other reasons.
“These drugs are inherently complex to compound safely, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s aim with this nomination is to ensure that patients receive only FDA-approved, safe, and effective semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.
FDA press officer Amanda Hils told WIRED via email that the agency “is reviewing the petition and will respond directly to the petitioner.”
If granted, the designation would have seismic implications for the compounding industry—and for the likely millions of people currently taking compounded GLP-1 drugs.
Injectable GLP-1 drugs including semaglutide and tirzepatide have been in shortage since 2022 because of their huge popularity. In the US, when the FDA declares that a drug is in shortage, certain licensed pharmacies are permitted to make “compounded” versions of the medication, which are mixed in-house and are supposed to contain the same active ingredients as the original drug.
Telehealth providers have capitalized on the GLP-1 drug shortage, offering patients compounded versions via quick virtual appointments. The practice has created tension with the pharmaceutical companies that make the brand-name drugs, since the compounded versions are sold at much lower prices. Ozempic and Wegovy can cost around $1,000 a month without insurance, while compounded semaglutide is advertised for as low as $100 a month online.
Unlike generic medications, which are manufactured after drug patents expire, compounded medications are not subject to FDA approval before hitting the market. This means that the FDA cannot vouch for the safety, effectiveness, or quality of compounded drugs before they’re sold to patients. The FDA has received multiple reports of adverse side effects, including hospitalization, related to possible dosing errors associated with compounded semaglutide products.
Compounding industry representatives object to the attempt to place the drug on the DDC lists.
“To me, this looks more like desperation and an attempt by Novo to protect its revenue stream than a serious scientific argument,” says Scott Brunner, the CEO of the trade group Alliance for Pharmacy Compounding. Brunner strenuously disputes the argument that semaglutide is too difficult to compound safely.
Novo Nordisk has filed 50 federal lawsuits against a variety of businesses selling compounded products, including telehealth clinics and medspas, as well as compounding pharmacies. It has alleged trademark infringement and unfair competition.
Earlier this month, the FDA initially declared that the shortage of tirzepatide, which goes by the brand names Mounjaro and Zepbound, had been resolved. The agency said it confirmed with the drug’s maker, Eli Lilly, that there would be enough availability and manufacturing capacity to meet present and projected national demand. This meant that most producers of compounded tirzepatide had to cease production abruptly. Eli Lilly went on the offensive shortly thereafter, sending hundreds of cease-and-desist letters to telehealth companies and compounders offering tirzepatide.
The compounding industry has pushed back against the very notion that the shortage has ended. A trade group called the Outsourcing Facilities Association filed a lawsuit in a Texas federal court against the FDA, claiming that tirzepatide is still in short supply, and ending the shortage is “abruptly depriving patients of a much-needed treatment and artificially raising drug prices.”
In response to the lawsuit, the FDA decided to reevaluate the decision to put tirzepatide on its shortage list; in the meantime, it is permitting some compounding pharmacies to keep making copies of the drug. Semaglutide remains on the shortage list—but when it is removed, this clash will escalate yet again.
