Lilly, Novo Fight Weight Loss Drug Compounders Over Shortage

Eli Lilly & Co. and Novo Nordisk A/S are asking a federal court to reject legal protections to drug compounders making copycat versions of the weight loss drug tirzepatide.

The two drugmakers moved Tuesday in the legal battle between the Food and Drug Administration and drug compounders over whether the the FDA lawfully determined that Lilly’s tirzepatide—a diabetes and obesity treatment branded as Mounjaro and Zepbound—is no longer in short supply in the US.

The Outsourcing Facilities Association and FarmaKeio Custom Compounding filed in January a motion for preliminary injunction in the US District Court for the Northern District of Texas that would prohibit the FDA from taking any action against them while they compound tirzepatide.

Lilly as an intervenor in the case, said Tuesday that the compounders can’t satisfy the factors for a preliminary injunction because they haven’t shown a risk of irreparable harm from the FDA’s decision.

“Plaintiffs fall well short of making any—let alone all—of those showings,” Lilly wrote in its opposition response. “Their claims are doomed on the merits, they have shown no risk of irreparable injury, and the equities strongly cut against allowing compounders to continue selling unapproved, untested, and often unsafe knockoffs of Lilly’s FDA-approved medicines.”

Novo, which manufacturers and sells blockbuster drugs Ozempic and Wegovy to treat diabetes and obesity, also moved Tuesday in an amicus brief supporting Lilly and the FDA.

The company argued that an injunction wouldn’t protect patients because they “would likely be harmed” if the court were to “enjoin FDA’s shortage decision and greenlight further compounding.”

The evidence submitted to the FDA to prove that the shortage remains also wasn’t sufficient, Novo argued, pointing to patient reports from “online reporting systems without any meaningful data integrity controls” and screenshots “purporting to show unavailability of approved drugs.”

“In any event, FDA rightly concluded that localized supply disruptions may exist even when there is not a nationwide drug shortage,” Novo wrote.

The Outsourcing Facilities Association did not immediately respond to a request for comment.

Lilly is represented by Kelly Hart & Hallman LLP, Clement & Murphy PLLC, and Kirkland & Ellis LLP.

Novo is represented by Covington & Burling LLP and Bowman and Brooke LLP.

The case is Outsourcing Facilities Association et al v. United States Food and Drug Administration, N.D. Tex., No. 4:24-cv-00953, opposition reply 2/18/25.