Novo Nordisk is intervening in the lawsuit filed by a drug compounders trade group against the FDA over the agency’s decision to declare the Wegovy shortage over. Eli Lilly did the same in a parallel case over Zepbound’s removal from the FDA shortage list and this week a judge denied the compounders’ injunction.
The legal battle continues between the FDA and compounding pharmacies over the latter party’s ability to produce blockbuster weight loss drugs such as semaglutide—marketed by Novo Nordisk as Wegovy—and tirzepatide—marketed by Eli Lilly has Zepbound. Following the removal of these drugs from the FDA shortage list, the compounders trade group Outsourcing Facilities Association (OFA) filed lawsuits in an attempt to continue making the lucrative drugs.
Now, Novo has followed Lilly in inserting itself in the nuanced legal situation just as a U.S. federal judge denies an injunction that would have given the OFA permission to continue making copies of Zepbound, Reuters reported.
Judge Mark T. Pittman of the US District Court for the Northern District of Texas ruled on Wednesday that Novo Nordisk can intervene in the case brought against the FDA by OFA in response to the removal of Wegovy from the agency’s shortage list, multiple outlets reported. This decision comes two months after a court granted Lilly similar permission for a separate lawsuit the OFA filed following Zepbound’s removal from the FDA’s shortage list and the same day that it sided with Lilly in denying an OFA injunction.
In the OFA’s most recent lawsuit, the trade organization calls the FDA’s decision “reckless and arbitrary decision,” contending that it will deprive patients of vital treatments for type 2 diabetes, obesity, cardiovascular disease and other serious medical conditions.
Pittman originally denied Novo’s request to get involved in the case, ruling it premature, but reversed its decision Wednesday after the Danish pharma filed a renewed motion. With Wegovy and Ozempic far and away its top selling products—over $8 billion in 2024 sales for the former and $16.9 billion for the latter—Novo has substantial interest in ensuring the FDA comes out ahead in this lawsuit, effectively prohibiting compounders from making knock-off copies.
When the agency declares a drug in shortage, Congress determined a doctor, pharmacist or licensed outsourcing facility is allowed to compound the drug appropriate to patient needs. With semaglutide no longer in that status, compounding pharmacies are no longer legally approved to make their own versions of the drug. According to the lawsuit, since the FDA placed semaglutide on the shortage list in 2022, patient demand has been satisfied thanks to pharmacies and outsourcing facilities.
The latest lawsuit closely mirrors the one filed by the OFA in October 2024 when the FDA ended the shortage of Eli Lilly’s GLP-1 + GIP combo, tirzepatide. The agency confirmed in December that tirzepatide was no longer in shortage status and gave compounders 90 days to cease production of their copycats. Lilly was eventually approved to intervene in that fight, which is before the same federal court.
The OFA has since filed a motion for a preliminary injunction, arguing the FDA was making a decision applicable to the entire compounding industry, which would constitute as a rule. It is not clear at this time whether this is the injunction that was denied on Wednesday. Rulemaking for the agency comes with strict requirements including engaging the public with a notice-and-coment period, per the Administrative Procedure Act.
Prior to the overturning of Chevron deference last year, questions have swirled about the FDA’s protocols for managing the drug shortage list. With pressures from parties like the OFA, the agency could face challenges in regulating the drug supply chain through this mechanism. The GLP-1 weight loss space is a particularly thorny area, with a thriving shadow market of not just compounders but research peptide makers all cashing in on the insatiable demand that originally sent Wegovy and Zepbound to the FDA’s shortage list.
Editor’s note (March 6): This story has been udpated to include news of the court’s Wednesday ruling in the case involving Eli Lilly.
