USITC Institutes Section 337 Investigation of Certain Over-the-Counter Topical Lidocaine Patches

The U.S. International Trade Commission (Commission or USITC) voted to institute an investigation of certain over-the-counter topical lidocaine patches. The products at issue in the investigation are described in the Commission's notice of investigation.

The investigation is based on a complaint filed on behalf of J.A.R. Laboratories LLC of Lake Forest, Illinois, on March 10, 2026. Supplements to the complaint were filed on March 23, 2026, and March 30, 2026. The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain over-the-counter topical lidocaine patches that infringe certain claims of the patent asserted by the complainant. The complainant requests that the USITC issue a limited exclusion order and cease and desist orders.

The USITC has identified the following respondents in this investigation:

• Veridian Healthcare LLC, Gurnee, Illinois
• Perrigo Company plc., Dublin, Ireland
• Perrigo Company, Allergan, Michigan
• Perrigo Direct, Inc., Peachtree City, Georgia
• Opella Healthcare Group SAS, Neuilly-sur-Seine, France
• Opella North America, Morristown, New Jersey
• Chattem, Inc., Chattanooga, Tennessee
• Hisamitsu Pharmaceutical Co., Inc., Tosu, Saga, Japan
• Hisamitsu U.S., Inc., Florham, New Jersey
• Hisamitsu America, Inc, Florham, New Jersey
• Reckitt Benckiser Group PL, Berkshire, United Kingdom
• Reckitt Benckiser LLC, Parsippany, New Jersey
• RB Health LLC, Parsippany, New Jersey

By instituting this investigation (337-TA-1498), the USITC has not yet made any decision on the merits of the case. The USITC's Chief Administrative Law Judge will assign the case to one of the USITC's administrative law judges (ALJ), who will schedule and hold an evidentiary hearing. The ALJ will make an initial determination as to whether there is a violation of section 337; that initial determination is subject to review by the Commission.

The USITC will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the USITC will set a target date for completing the investigation. USITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.