notice Published 2026-04-14

Certain Over-the-Counter Topical Lidocaine Patches; Notice of Institution of Investigation

📌 ETDETA brief — importer impact summary (educational)

Brief takeaway: The ITC has opened a Section 337 investigation into certain over-the-counter topical lidocaine patches accused of patent infringement, which could eventually lead to import restrictions.

What changed: According to the notice, a complaint was filed on March 10, 2026 (supplemented March 23 and March 30, 2026) by J.A.R. Laboratories LLC, and the Commission has instituted an investigation. The notice states the complaint alleges violations of Section 337 based on importation, sale for importation, and sale after importation of these patches by reason of infringement of certain claims of U.S. Patent No. 12,109,181.

Who's affected: The notice names certain over-the-counter topical lidocaine patches as the products at issue. It does not specify HTS codes or countries of origin. The notice states the complainant requests a limited exclusion order and cease and desist orders, which may be relevant to importers of such patches.

What to review:
- Review whether your imported products fall within the described category of OTC topical lidocaine patches.
- Confirm with your broker or counsel whether your goods may implicate the '181 patent claims.
- Check the ITC docket for the named respondents and the scope of any proposed exclusion order.
- Confirm the investigation's status and any effective remedy dates as the proceeding develops.

This is general information, not legal advice and not a compliance determination — confirm specifics with a licensed customs broker or trade counsel.

Official notice

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on March 10, 2026, under section 337 of the Tariff Act of 1930, as amended, on behalf of J.A.R. Laboratories LLC of Lake Forest, Illinois. Supplements to the complaint were filed on March 23, 2026 and March 30, 2026. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain over-the- counter topical lidocaine patches by reason of the infringement of certain claims of U.S. Patent No. 12,109,181 ("the '181 patent"). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.

Source: Federal Register · International Trade Commission · Read the official notice ↗

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This update is a general educational summary based on public CBP CSMS / Federal Register information. It is not legal advice, customs broker advice, a final classification, duty determination, entry instruction, or compliance determination. Importers should confirm applicability, effective dates, HTSUS/Chapter 99 reporting, rates, refunds, PSC procedures, and filing instructions with their licensed customs broker, trade counsel, and/or CBP.