January 3, 2025 01:08 PM ESTUpdated 02:13 PM PharmaLawHealth Tech
Eli Lilly seeks to join lawsuit over end of tirzepatide shortage
Shelby Livingston
Senior health tech reporter
Eli Lilly has asked to intervene in litigation between a compounding pharmacy trade group and the FDA over the agency’s decision to remove Lilly’s blockbuster obesity and diabetes drug tirzepatide from its official shortage list.

The drugmaker wants to protect its interests “in preserving its exclusive right to sell its FDA-approved medicines,” Lilly said in a Wednesday court filing in the US District Court for the Northern District of Texas.

The litigation has big implications for the market for compounded GLP-1 drugs, which has become a goldmine for compounding pharmacies and telehealth companies. Typically, mixing up copies of a brand-name drug, a process known as compounding, is allowed only when there’s a shortage.

In early October, the FDA declared the tirzepatide shortage over after nearly two years. It was quickly sued by the Outsourcing Facilities Association, a trade group for large compounding facilities, which argued that the FDA ignored evidence that Lilly’s tirzepatide — sold as diabetes drug Mounjaro and obesity drug Zepbound — remained hard for patients to get.

The court stayed the litigation when the agency said it would reconsider the matter. But last month, the FDA reaffirmed that the shortage had been resolved, meaning that compounding pharmacies would soon have to stop making cheaper copies of the drug.

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The FDA and the OFA on Thursday proposed that the case be reopened, as the OFA plans to ask for a preliminary injunction that would stop the FDA’s removal of tirzepatide from shortage while the litigation proceeds, according to a separate court filing. Lilly is hoping its intervention as a defendant helps “bring this suit to a swift end,” it wrote in its Wednesday filing.

Many patients seek compounded GLP-1s because they can’t find brand-name versions on pharmacy shelves, or because they’re much cheaper than branded drugs, which aren’t covered widely by insurers and have list prices that can reach more than $1,000 a month.

The case could also affect how the FDA approaches semaglutide, sold by Novo Nordisk as Ozempic and Wegovy. That drug remains in shortage for now.

In its filing, Lilly argued that the compounding pharmacies want to keep tirzepatide on the shortage list because it benefits them financially. The drugmaker reiterated its position that compounded drugs, which aren’t FDA-approved, are potentially dangerous for patients.

“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 company said in the filing.

The OFA said it plans to file for a preliminary injunction once it receives an unredacted version of the FDA’s memo from December regarding its decision to reaffirm the tirzepatide shortage. The parties will negotiate a protective order allowing OFA access to the redacted confidential information.

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AUTHOR
Shelby Livingston
Senior health tech reporter
[email protected]

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