Judge Dismisses Eli Lilly’s Lawsuit Against Compounded Drug Maker

A federal judge in Delaware has dismissed a lawsuit filed by Eli Lilly, the manufacturer of the popular weight loss medications Mounjaro and Zepbound, against Strive Pharmacy, a telehealth company accused of misleading marketing practices. The lawsuit, which was brought in the U.S. District Court for Delaware, claimed Strive was engaging in “false marketing claims and deceptive business practices” regarding its compounded version of tirzepatide, the active ingredient in Eli Lilly’s drugs.

Strive Pharmacy, based in Arizona, offers a “personalized” formulation of tirzepatide that includes vitamin B12 and glycine. The company asserts that these additives help mitigate nausea and aid in maintaining muscle mass. By modifying the chemical composition of the drug, Strive aims to avoid infringing on Eli Lilly’s patents.

In his ruling, Judge Stephanos Bibas of the U.S. Court of Appeals for the Third Circuit, who presided over the case by designation, stated that Eli Lilly failed to establish a sufficient connection between Strive’s online advertising and the state of Delaware. He emphasized that even in the digital era, “personal jurisdiction has ‘real limits.’”

Following the FDA’s removal of GLP-1 medications, including tirzepatide and semaglutide, from its drug shortage list, Eli Lilly initiated several lawsuits against compounding pharmacies. These pharmacies had previously been allowed to produce GLP-1 drugs due to the shortage. They were required to cease production of these compounded drugs by May 22 after the Outsourcing Facilities Association’s legal challenges against the FDA were unsuccessful.

Compounding pharmacies and telehealth companies have since begun marketing customized formulations of tirzepatide and semaglutide. These versions are often significantly more affordable, with out-of-pocket costs ranging from $129 to $497 per month, compared to over $1,000 for brand-name options. Furthermore, insurance coverage for brand-name drugs frequently necessitates a body mass index (BMI) of 30 or higher, with some insurers imposing even stricter requirements.

Judge Bibas recognized the value of compounded drugs for patients with specific needs or allergies, calling them a “godsend.” He noted that these alternatives can alleviate issues related to drug shortages and high costs, stating, “If the brand-name medication is expensive or in short supply, compounding pharmacies can often still sell the same molecule in combination with other ingredients.”

Strive Pharmacy’s Chief Marketing Officer, Zachary Shurtleff, expressed determination to continue advocating for patient access to compounded medications. In a recent statement to On the Pen, a newsletter focused on obesity medicine, he asserted that the company would persist in fighting for patient rights.

The dismissal of Eli Lilly’s lawsuit was made without prejudice, allowing the pharmaceutical company the option to either provide additional jurisdictional facts or pursue legal action against Strive in Arizona. This ruling follows another dismissal last month of Eli Lilly’s lawsuit against Willow Health, another telehealth firm accused of similar deceptive practices regarding compounded tirzepatide products.

The Alliance for Pharmacy Compounding, a nonprofit organization representing compounding pharmacies, remarked that the judicial trends suggest courts are recognizing the essential role these pharmacies play in serving patients within the legal and regulatory framework.

Eli Lilly has not yet responded to requests for comment on the recent ruling.