March 6 (Reuters) — A U.S. federal judge has ruled that compounding pharmacies can no longer produce copies of Eli Lilly’s (LLY.N) popular weight-loss and diabetes drugs, Zepbound and Mounjaro.
The ruling, issued late Wednesday, responds to a lawsuit filed in October by a compounding industry group challenging the U.S. Food and Drug Administration’s (FDA) decision to remove tirzepatide—the active ingredient in these medications—from the drug shortage list.
Previously, compounding pharmacies were allowed to produce tirzepatide-based drugs in large quantities as long as the FDA recognized a shortage. The Outsourcing Facility Association, the lead plaintiff in the case, estimated that millions of people had been using compounded versions of the drug.
FDA Sets Deadline for Compliance
Under FDA regulations, pharmacies cannot routinely produce copies of commercially available drugs unless there is a shortage. The agency had stated that it would not enforce restrictions against compounders until the court issued a ruling.
Following the judge’s decision, smaller compounding pharmacies, which operate under state regulations and fill prescriptions for individual patients, must immediately stop making tirzepatide copies. Larger outsourcing facilities, which manufacture compounded drugs in bulk and are regulated by the FDA, have until March 19 to comply.
Industry Group Challenges FDA Decision
In their lawsuit, compounders argued that the FDA relied solely on information from Eli Lilly to determine that there was no longer a shortage, despite continued patient difficulties in accessing the drugs. They sought a preliminary order preventing the agency from taking enforcement action while the lawsuit proceeded.
However, U.S. District Judge Mark Pittman denied the request. His ruling was sealed, meaning neither Reuters nor the Outsourcing Facility Association could review the full decision.
“We are stunned by the judge’s decision, but without access to the sealed order, we cannot comment on the reasoning behind it,” said Lee Rosebush, chairman of the Outsourcing Facility Association. He added that the group is considering its next steps.
The FDA declined to comment on the ruling. Lilly, however, welcomed the decision, stating that it “marks the end of the road for mass compounding” of its drugs. The company pledged to work with regulators and law enforcement to stop the sale of unauthorized copies.
Similar Legal Battle Over Novo Nordisk’s Drugs
The FDA recently removed Novo Nordisk’s (NOVOb.CO) weight-loss and diabetes medications, Wegovy and Ozempic, from its shortage list. This move has also led to a lawsuit from compounding pharmacies, which remains pending.
While insurers typically cover Lilly and Novo Nordisk’s drugs for diabetes, many do not provide coverage for their weight-loss versions. As a result, some patients have turned to compounded alternatives, which are often significantly cheaper.
