In September, HydraMed IV LLC (“HydraMed”), a mobile intravenous (“IV”) therapy company, was ordered by a Federal District Court in Colorado to stop: (1) using Eli Lilly’s trademarks for MOUNJARO® and ZEPBOUND® in HydraMed’s advertising, promoting, and marketing; (2) advertising, stating, or otherwise suggesting that HydraMed’s compounded drug products are genuine or otherwise generic versions of MOUNJARO® and ZEPBOUND®; (3) advertising, stating, or suggesting that HydraMed is associated with Eli Lilly and its products; and (4) advertising, stating, or suggesting that HydraMed’s compounded drug products are approved by the FDA or have been the subject of clinical studies, or otherwise achieve certain therapeutic outcomes.
Additionally, the court ordered HydraMed to disclose the following statement in all advertisements, social media statements, press releases, articles, websites, and other communications regarding HydraMed’s compounded tirzepatide drug products:
“Compounded versions of tirzepatide are not associated with Eli Lilly & Company and/or its genuine MOUNJARO® and/or ZEPBOUND® products. Compounded versions of tirzepatide are not FDA approved, and neither the FDA nor any global regulatory agency has reviewed these products for safety, quality, or efficacy.”
Notably, this order is part of larger pattern of Eli Lilly filing suits in federal court based on allegations that companies compounding drugs, such as medical spas and pharmacies, are falsely advertising that they sell and are otherwise infringing on Eli Lilly’s trademarked MOUNJARO® and ZEPBOUND® products.
How Frier Levitt Can Help
Navigating the compounding and marketing of GLP-1 agonists and other compounded drug products is often complex and typically triggers both federal and state rules and regulations related to marketing. These can range from FTC guidance regarding false and misleading advertising to the FDA framework for marketing compounded drug products, to other federal and state agency rules related to marketing drug products and conducting online pharmacy activities. In addition to this, stakeholders must be cognizant of applicable intellectual property protection for competitive products and ensure that their marketing content does not create liability as it relates to infringement.
If you are a pharmacy, prescriber, or administrative entity whose business model includes the marketing of compound drug products, including GLP-1 agonists, contact Frier Levitt to speak with an attorney experienced in reviewing these models and their associated marketing content for compliance with applicable law.
