Eli Lilly Joins FDA Lawsuit Over Compounded Obesity Drugs, Seeks ‘Quick End’ and ‘Protect Its Interests’

As many expected, Eli Lilly and company (NYSE:LYLY) filed a motion to intervene as a defendant in a case between Outsourcing Facilities Association and FarmaKeio Custom Compounding against the FDA.

the court has now ordered the Subcontracting Facilities Association to respond by Jan. 15, and Eli Lilly’s response was due by Jan. 21.

What happened: In early October, the FDA determined that the shortage of Eli Lilly’s tirzepatide injections had been resolved.

The US health regulator remembered aggravating legal restrictions on making copies of FDA-approved medications.

Also read: Health costs for US employers to rise in 2025 driven by weight loss: report

Tirzepatide injection, under the brand names Mounjaro and Zepbound, has been in shortage since 2022 due to increased demand, allowing compounding pharmacies and outsourcing facilities to produce the drug and meet patient demand.

The composition groups filed a complaint in October 2024 alleging that the drug’s removal from the shortage list is based solely on the manufacturer production capabilities.

Critics argued that this move ignores evidence of continued supply disruptions. While the FDA acknowledged ongoing “localized intermittent supply disruptions,” the agency proceeded with its decision, which was described as arbitrary and in violation of established procedures.

Later in October, the FDA said it was reevaluating its decision to ban compounding pharmacies from supplying cheaper versions of Eli Lilly Medications for weight loss and diabetes..

In December, the FDA revised its previous decision and announced that the shortage had been resolved based on its current analysis.

The agency allowed pharmacies and outsourcing facilities to prepare, distribute or dispense tirzepatide injections until February 18 and March 19, 2025, respectively.

The FDA emphasized that it can still take action against violations unrelated to the shortage.

Why it is important: in one movement filed In the New Year, Eli Lilly said it seeks to intervene to protect its interests and help bring this lawsuit to a quick end.

Eli Lilly says: “Plaintiffs seek to reverse the FDA’s determination that there is no shortage of Mounjaro and Zepbound, so that plaintiffs can claim the right to continue (illegally) mass selling and marketing unapproved copies (and, with too often, unsafe) from Lilly’s medicines. The reason for his lawsuit is transparent: in his words, the FDA’s shortage determination “… . . cause them to not capitalize on their investment” and “destroy their income.”

He presentation highlights Lilly’s “direct, substantial and legally protectable interest in the process,” as it has invested more than $23 billion to increase its manufacturing capacity.