As expected by many, Eli Lilly And Co LLY filed a motion to intervene as a defendant in a case between the Outsourcing Facilities Association and FarmaKeio Custom Compounding against the FDA.
The court has now ordered the Outsourcing Facilities Association to respond by January 15, with Eli Lilly’s reply due by January 21.
What happened: In early October, the FDA determined that Eli Lilly’s tirzepatide injection shortage had been resolved.
The U.S. health regulator reminded compounders of the legal restrictions on making copies of FDA-approved drugs.
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Tirzepatide injection, branded as 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 compounding groups filed a complaint in October 2024 alleging that removing the drug from the shortage list is based solely on the manufacturer’s production capabilities.
Critics argued that this move disregards evidence of continued supply disruptions. While the FDA acknowledged ongoing “intermittent localized supply disruptions,” the agency proceeded with its decision, which was described as arbitrary and violated established procedures.
Later in October, the FDA said it was reassessing its decision to ban compounding pharmacies from supplying cheaper versions of Eli Lilly’s weight loss and diabetes drugs.
In December, the FDA reviewed its earlier decision and announced that the shortage had been resolved based on its current analysis.
The agency allowed the pharmacies and outsourcing facilities to compound, distribute, or dispense tirzepatide injections until February 18 and March 19, 2025, respectively.
The FDA emphasized that it may still take action against violations unrelated to the shortage.
Why It Matters: In a motion filed on New Year, Eli Lilly said it seeks to intervene to protect its interests and help bring this suit to a swift end.
Eli Lilly says, “Plaintiffs seek to reverse FDA’s determination that Mounjaro and Zepbound are not in shortage, so Plaintiffs can claim entitlement to continue to mass-selling and (illegally) mass-marketing unapproved (and, all too often, unsafe) copies of Lilly’s medicines. The motive for their suit is transparent: in their words, FDA’s shortage determination “will . . . cause [them] to fail to capitalize on their investment” and “destroy their revenues.”
The filing highlights Lilly’s “direct, substantial, legally protectable interest in the proceedings” as it has invested over $23 billion to increase its manufacturing capacity.
Price Action: At last check on Friday, LLY stock was down 0.01% at $778 during the premarket session.
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