Following a similar decision in case the trade group Outsourcing Facilities Association brought against FDA over its decision to declare the end of the shortage of Novo Nordisk’s semaglutide, Judge Mark Pittman agreed that Eli Lilly’s tirzepatide is in sufficient supply, meaning compounding pharmacies can no longer sell the lucrative weight loss drugs.
A Texas Judge on Wednesday took Eli Lilly’s side in its ongoing court battle over compounded versions of its blockbuster GLP-1 drug tirzepatide, according to reporting from Reuters.
In a sealed order, Judge Mark Pittman upheld the FDA’s prior declaration that Lilly’s tirzepatide was no longer in shortage. In March, Pittman issued a verdict that prevented compounders from producing their remixed versions of the weight loss drug while the case was ongoing, as Reuters reported at the time. Then late last month, Pittman rejected the OFA’s request for an injunction that would have allowed compounders to continue producing their copycat versions of Novo Nordisk’s blockbuster GLP-1 therapy semaglutide, foreshadowing this week’s positive outcome for Lilly.
Compounding is the process by which pharmacies and doctors can alter the formulation of FDA-approved drugs, creating medicines that are more suited for patients’ individual needs. But since the resulting product has not been granted regulatory clearance, compounding as a practice is under certain restrictions—one of which is that some drugs can only be remixed if there is a shortage of supply.
The case over Lilly’s GLP-1 drug traces back to October last year, when the FDA first took tirzepatide off its shortage list. The move was met with swift backlash from compounding pharmacies, represented by the Outsourcing Facilities Association (OFA), a compounders trade group. Just days after the FDA’s announcement, the group sued the regulator, calling the decision to end the tirzepatide shortage “reckless,” “arbitrary” and one that did not have “any semblance of lawful process.”
The FDA ended the tirzepatide shortage “without soliciting input from affected parties and the public, and without meaningful rationale,” the OFA wrote.
Lilly subsequently joined the legal battle to represent its interests in the case, and in December 2024, the FDA stood by its decision to end the tirzepatide shortage. The move effectively disallowed compounding of tirzepatide and gave pharmacies until mid-March to comply. Shortly after, Lilly unleashed a barrage of lawsuits against telehealth providers—which the pharma called “bad actors”—that have refused to stop selling compounded tirzepatide.
Mirroring the case of tirzepatide, the FDA in February formally ended the shortage for Novo’s semaglutide, which also met with an OFA lawsuit that Novo later joined. The court win last month came as a relief to Novo, which in March conceded that compounding has been hurting sales of its weight loss semaglutide brand Wegovy. Compounders are “damaging our business,” CEO Lars Fruergaard Jorgensen told investors at the time, adding that once the copycat drugs go off the market in May, “I sincerely hope many of those patients will then come back to Novo Nordisk.”
