Judge Dismisses Eli Lilly’s Lawsuit Against Compounding Pharmacy

A federal judge in Delaware has dismissed a lawsuit filed by Eli Lilly, the manufacturer of popular weight loss drugs Mounjaro and Zepbound, against Strive Pharmacy, a telehealth company. Eli Lilly accused Strive of engaging in “deceptive” marketing practices concerning its compounded versions of the drug tirzepatide. The ruling was made by Judge Stephanos Bibas in the U.S. District Court for Delaware.

The lawsuit claimed that Strive Pharmacy, based in Arizona, used misleading marketing to promote its “personalized” formula of tirzepatide, which it combines with vitamin B12 and glycine. Eli Lilly contended that these additions constituted “false marketing claims and deceptive business practices.” By altering the drug’s chemical composition slightly, Strive can navigate around patent restrictions.

In his ruling, Judge Bibas stated that Eli Lilly did not establish a sufficient connection between Strive’s online advertisements and the state of Delaware. He emphasized that even in the digital age, personal jurisdiction has “real limits.” “Even in our digital age, personal jurisdiction has ‘real limits,’” Judge Bibas wrote.

Eli Lilly initiated several lawsuits against compounding pharmacies in April after the FDA removed tirzepatide and semaglutide from its drug shortage list. Compounding pharmacies had been producing these GLP-1 medications due to earlier shortages, and they were granted until May 22 to cease production following unsuccessful legal challenges from the Outsourcing Facilities Association against the FDA’s rulings.

This dismissal allows Eli Lilly the option to either provide more jurisdictional details or pursue legal action against Strive in Arizona. The company has been active in pursuing multiple lawsuits against compounding businesses for marketing what Eli Lilly describes as mass-produced versions of tirzepatide under the guise of customization.

Compounded versions of GLP-1 medications are generally more affordable than their brand-name counterparts, with patients often paying between $129 and $497 monthly. In contrast, brand-name versions can exceed $1,000 per month, and insurance coverage is typically limited to patients with a body mass index (BMI) of 30 or higher.

Judge Bibas acknowledged the value of compounded drugs, describing them as a “godsend” for patients with specific needs or drug allergies. “They can also provide a workaround to shortages of popular drugs,” he noted, indicating that compounding pharmacies can offer the same active ingredients in combination with other substances when brand-name medications are either expensive or unavailable.

In a statement to On the Pen, a newsletter focused on obesity medicine, Zachary Shurtleff, Chief Marketing Officer of Strive Pharmacy, expressed the company’s commitment to advocating for patient access to compounded medications.

This ruling follows a similar decision last month, where a U.S. District Court judge dismissed a lawsuit against Willow Health, another telehealth provider accused of misleading marketing regarding compounded versions of tirzepatide. Both cases were dismissed without prejudice, suggesting a judicial recognition of the role compounding pharmacies play in meeting patient needs within legal frameworks.

The Alliance for Pharmacy Compounding, a non-profit representing compounding pharmacies, commented on the trend, stating, “You begin to get the sense that when it comes to GLP-1 compounding, courts believe compounding pharmacies are serving their patients well.”

Eli Lilly has not yet responded to requests for comments regarding the recent dismissal.