Lilly files a Section 337 complaint with the ITC against 11 tirzepatide sellers

Eli Lilly and Company filed a complaint with the U.S. International Trade Commission on October 19, 2023, asking the agency to stop imports of "certain products containing tirzepatide and products purporting to contain tirzepatide" sold by 11 companies in the United States and abroad ^[2]. Tirzepatide is the active ingredient in Lilly's Mounjaro and Zepbound.

The complaint was brought under Section 337 of the Tariff Act of 1930, the law the ITC uses to police unfair practices in imports ^[2]. Lilly supplemented the filing on November 10, 2023, and the Commission voted to open an investigation, numbered 337-TA-1377, which was announced on November 21, 2023 and published in the Federal Register on November 27, 2023 ^[1][2].

What Lilly alleged

This is not a patent case. The complaint alleges infringement of U.S. Trademark Registration No. 6,809,369, plus false designation of source and false and misleading advertising, with the claimed effect of destroying or substantially injuring a U.S. industry ^[2]. In plain terms, Lilly argued that sellers were importing and selling products presented as tirzepatide in ways that traded on its brand and misled buyers.

The Commission identified 11 respondents: Arctic Peptides LLC of Ankeny, Iowa; Audrey Beauty Co. of Hong Kong; Biolabshop Limited of Lancaster, United Kingdom; Mew Mews Company Limited of Hong Kong; Steroide Kaufen of Bialystok, Poland; Strate Labs LLC of Spring, Texas; Super Human Store of Barcelona, Spain; Supopeptide of Cedar Grove, New Jersey; Triggered Supplements LLC, doing business as The Triggered Brand, of Clearwater, Florida; Unewlife of Cedar Grove, New Jersey; and Xiamen Austronext Trading Co., Ltd., doing business as AustroPeptide, of Fujian, China ^[1].

Lilly asked the Commission for a general exclusion order or, as an alternative, a limited exclusion order, plus cease and desist orders ^[1][2]. A general exclusion order is the broader remedy: it can bar matching products at the border regardless of who is shipping them, not just the named companies.

The ITC stressed that opening an investigation is not a ruling. "By instituting this investigation (337-TA-1377), the USITC has not yet made any decision on the merits of the case," the agency said, adding that an administrative law judge would hold an evidentiary hearing and issue an initial determination subject to Commission review ^[1].

Why it matters for patients

During the tirzepatide shortage years, some people turned to online sellers advertising "research peptides" or other unbranded versions of the molecule. This case is about those channels rather than about pharmacies dispensing Mounjaro or Zepbound.

The phrase the Commission used twice is the key one for consumers: products "purporting to contain tirzepatide" ^[1][2]. That language signals that some items sold online may not contain what the label says. The sources here do not include any lab testing, potency results, or reports of harm from the named sellers, so what was actually in those products is not established in these documents.

The practical consequence, if Lilly wins, is supply-side: exclusion orders are enforced at the border by customs authorities, and cease and desist orders target domestic sales, which can shut off specific websites and shipments. The case says nothing about the availability of FDA-approved tirzepatide through normal pharmacy channels.

What happens next

The ITC said it would set a target date for completing the investigation within 45 days of institution, and that remedial orders take effect when issued and become final 60 days later unless the U.S. Trade Representative disapproves them for policy reasons ^[1].

The docket shows how the case unfolded after that. The Commission allowed amendments to the complaint in May and June 2024 ^[2]. On December 13, 2024, it requested submissions on the public interest ^[2]. On January 28, 2025, it declined to review an initial determination finding respondents in violation of Section 337 and asked for written submissions on remedy, the public interest and bonding ^[2]. On April 15, 2025, the Commission issued a general exclusion order, a limited exclusion order and cease and desist orders, and terminated the investigation ^[2].