INDIANAPOLIS — Eli Lilly has filed a complaint with the U.S. International Trade Commission with the aim of stopping companies from importing, selling or distributing a product they say include a product that Eli Lilly invented.
According to the complaint, filed on Thursday, the company invented tirzepatide, a product within Mounjaro, a drug that helps treat adults with type 2 diabetes mellitus. The U.S. Food and Drug Administration has approved Mounjaro in May 2022 for the treatment and Eli Lilly, along with its related companies, market and sell that drug, which contains tirzepatide.
Officials said that Mounjaro is an injectable prescription medicine that is used, along with diet and exercise, to improve blood sugar in adults with type 2 diabetes mellitus.
The complaint alleges that a number of companies and products have claimed that it has tirzepatide and that the unapproved drug products are affiliated with Eli Lilly and/or have been approved by the FDA. The companies include:
- Super Human Store
- Audrey Beauty Co., Ltd.
- Mew Mews Co. Ltd.
- Steroide Kaufen
- Triggered Supplements LLC (d/b/a The Triggered Brand)
- Strate Labs LLC
- Xiamen Austronext Trading Co., Ltd. (d/b/a AustroPeptide)
- Artic Peptides LLC
The complaint claims that all the companies have provided false and misleading advertisements regarding their unapproved products.
“All proposed respondents are misleading the public into believing their unapproved drug products have been approved by the FDA when they have not,” the complaint reads. “In fact, proposed respondents market tirzepatide not only to treat diabetes, but also for weight loss – even though no drug containing tirzepatide has been approved by the FDA for weight loss.”
The complaint claims that some of the companies have also violated the use of Eli Lilly’s Mounjaro trademark, causing confusion among the public on what products are legitimate. The complaint also claims that some of the companies also imply false affiliation with or sponsorship by Eli Lilly.
“The Proposed Respondents’ respective violations have caused substantial injury to the domestic industry related to the manufacture of articles on and in connection with which Lilly uses the Mounjaro mark,” the complaint reads. “Lilly seeks as relief a permanent general exclusion order prohibiting entry into the United States of infringing and/or unfairly traded products containing or purporting to contain tirzepatide, including each of the unapproved drug products.”
The company is also seeking permanent cease-and-desist orders prohibiting the companies from distributing products or having products that purport to contain tirzepatide.
In a statement from Eli Lilly, officials said:
Lilly has filed a complaint before the U.S. International Trade Commission to stop companies from importing, selling, or distributing what those companies assert is tirzepatide, the active pharmaceutical ingredient (API) in Mounjaro®. The FDA does not review the products these companies are importing or distributing for safety, quality, or efficacy — nor does any other global regulatory agency. In fact, testing shows that at least one of the companies purporting to sell tirzepatide was actually selling nothing more than sugar alcohol. Lilly is committed to patient safety and, therefore, seeks to prevent these companies from exposing patients to potentially serious health risks.Eli Lilly Officials