U.S. ITC Opens Section 337 Investigation into Imported OTC Lidocaine Patches

The U.S. International Trade Commission (ITC) formally instituted a Section 337 investigation on April 9, 2026, targeting imported over-the-counter (OTC) topical lidocaine patches. A Federal Register notice published April 14, 2026 confirmed that the investigation will determine whether five respondent companies have violated Section 337 of the Tariff Act of 1930 by importing products that infringe claims 1 and 5 of U.S. Patent No. 12,109,181 (the “‘181 patent”), owned by J.A.R. Laboratories LLC of Lake Forest, Illinois.

J.A.R. Laboratories filed its complaint with the ITC on March 10, 2026, with supplements filed on March 23 and March 30. The complainant alleges that five foreign-origin suppliers are importing or selling for import OTC lidocaine patches that infringe the ‘181 patent. Respondents identified in reporting on the matter include Hisamitsu Pharmaceutical Co. Inc. and Perrigo Co., along with three other companies. The institution of an investigation does not itself constitute a finding of infringement; rather, it signals that the ITC has determined the complaint satisfies the statutory threshold for opening a formal proceeding.

J.A.R. Laboratories is seeking both a limited exclusion order — which would bar U.S. Customs from allowing infringing products through ports of entry — and cease and desist orders against each respondent. Section 337 investigations typically reach a final determination within 15 to 18 months of institution, with an Administrative Law Judge (ALJ) presiding over fact-finding on infringement and the domestic industry requirement.

The ‘181 patent covers formulation and manufacturing aspects of OTC topical lidocaine patches, a product category used widely in the United States for localized pain relief. The U.S. OTC topical analgesic patch market is estimated at several hundred million dollars annually. The entry of generic and imported alternatives has intensified competition, making ITC exclusion orders a strategically attractive enforcement tool for domestic patent holders seeking to protect market share.

The case can be tracked on the ITC’s active Section 337 investigations page. Upcoming ALJ scheduling orders and any motions for temporary relief will be key developments to monitor.