Eli Lilly has made its position clear in the ongoing lawsuit over compounded tirzepatide. The drugmaker filed its response to the Outsourcing Facilities Association’s request for a preliminary injunction and, unsurprisingly, it is taking an aggressive stance against compounding. Lilly argues that the FDA was right to remove tirzepatide from the shortage list and that allowing compounded versions to remain on the market is both illegal and dangerous.
At the heart of Lilly’s argument is its claim that it has done everything necessary to meet demand. The company points to its $23 billion investment in manufacturing and states that since August 2024, it has been producing enough Mounjaro and Zepbound to eliminate any legitimate nationwide shortage. Lilly argues that the FDA independently reviewed this data and correctly determined that compounded tirzepatide is no longer necessary under federal law.
Lilly’s filing is packed with warnings about the dangers of compounded tirzepatide. The company refers to compounded versions as risky knockoff drugs and cites multiple safety issues including sterility problems, bacterial contamination, and mislabeled products that have led to recalls and public health warnings. The company also takes aim at compounders who use unregulated or chemically modified versions of tirzepatide, arguing that these formulations do not meet the quality standards of FDA-approved Mounjaro and Zepbound.
Lilly directly challenges the compounding industry’s evidence for keeping tirzepatide on the shortage list. It argues that compounders have relied on anecdotal patient reports, misleading screenshots, and incomplete surveys rather than objective data.
The company claims that the FDA gave compounders an opportunity to present real supply chain data but found their submissions lacked credibility. Lilly accuses compounders of intentionally ignoring wholesale inventory levels while focusing on isolated pharmacy-level issues to manufacture a false shortage narrative.
Lilly is also pushing back against the idea that OFA and FarmaKeio have standing to sue. The company argues that OFA has not proven harm to its members and that FarmaKeio, as a 503A pharmacy, is not legally allowed to mass-produce tirzepatide under shortage exemptions. This is a direct attempt to undercut the legitimacy of the case before the court even considers the bigger legal questions.
The filing also makes it clear that Lilly sees compounded tirzepatide as a direct threat to both patients and the pharmaceutical regulatory system. The company argues that allowing compounders to continue selling tirzepatide undermines the exclusivity protections granted to FDA-approved drugs and that it weakens the oversight that ensures patient safety. Lilly warns that granting the preliminary injunction would cause irreparable harm by allowing unapproved versions of its medication to remain on the market.
This response sets the stage for the next major moment in the case. Judge Pittman could issue a ruling on the preliminary injunction as soon as February 25. If the court rules in favor of OFA and FarmaKeio, compounded tirzepatide will be protected from enforcement while the broader legal battle continues. If the court denies the injunction, compounders will be at risk of FDA enforcement action once the agency’s current enforcement discretion expires.
With Novo Nordisk, the FDA, and now Eli Lilly all aligned against the compounding industry, the fight over tirzepatide is becoming a defining moment in the battle between drugmakers and compounders. The ruling on February 25 could shape the future of patient access, pricing, and regulation in the obesity and diabetes market. Whether the court sides with compounding or upholds the FDA’s ban, this case is far from over.
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