On Friday, June 12, 2026, the US Food and Drug Administration (FDA) released a draft guidance document, Forms FDA 3542a and FDA 3542: Questions and Answers (“Draft Guidance”), which is directed towards new drug application (NDA) holders and patent owners submitting patent information for listing in FDA’s “Orange Book.”  The Draft Guidance is a useful complement to existing instructions from FDA,¹ and clarifies several key aspects including FDA’s submission procedures, Orange Book listing for discontinued drug products, corrections of Orange Book listings, and the listing of method of use patent claims.  FDA has requested that stakeholders submit comments on the Draft Guidance by August 14, 2026.²

The Draft Guidance provides a high-level introduction to the regulatory procedures and the mechanics of Forms FDA 3542a and 3542 for NDA holders and patent owners.  However, the Draft Guidance does not address more complicated patent listing questions that often arise when preparing these forms for submission, including eligibility for listing and Use Code drafting.

Background

By way of brief background, NDA holders are required to submit patent information to FDA regarding each patent

for which a claim of patent infringement could reasonably asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that –

1. claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
2. claims a method of using such drug for which approval is sought or has been granted in the application….³

By regulation, FDA requires NDA holders to submit this patent information on Form FDA 3542a (upon submission of an NDA or a supplement) and Form FDA 3542 (within 30 days of approval of the NDA or supplement, or the issuance of a new patent for already approved drugs).⁴

FDA’s Draft Guidance Document

Although much of the information in the Draft Guidance is readily available in the regulations at 21 CFR 314.53 or in the existing instruction documents, the Draft Guidance does clarify a few key points:

• Submitting corrections or changes to previously submitted Use Codes: The draft guidance makes clear that NDA holders cannot simply “modify” an existing Use Code, but must expressly state in field 1.h their intention to “remove” the existing Use Code and “add” a new Use Code.  This reflects agency policy that has been in place for several years.
• Method of Use patents: For patents that only contain method of use claims – without any corresponding drug substance or drug product claims – the Draft Guidance clarifies that the NDA holder can leave fields 2 (drug substance) and 3 (drug product) completely blank.
• Submission procedures: The Draft Guidance helpfully reiterates that only NDA holders (or their agents, attorneys or representatives) can submit Forms 3542a and 3542.  While the patent owner (if different from the NDA applicant) may assist in filling out the forms and even signing them, only the NDA applicant may submit the forms to FDA.  Relatedly, the Draft Guidance reminds NDA holders to submit the forms electronically to their NDA(s) through the Electronic Submissions Gateway – and not to submit any courtesy copies to the Orange Book staff or through any other agency channels.
• Discontinued drug products: For products that have been withdrawn from marketing, but whose NDAs remain approved, FDA reiterates that NDA holders have an ongoing obligation to submit patent information, including with regard to newly issued patents.

Conclusion

Orange Book patent listing is a key aspect of the Hatch-Waxman scheme and a statutory requirement for NDA holders.  It is critical that NDA holders and patent owners ensure regulatory compliance when submitting patent information to FDA, but they must also think strategically about potential implications for patent litigation.  The draft guidance document addresses some of the most common regulatory compliance questions our clients routinely ask us when preparing patent submission forms.

At WilmerHale, our FDA Regulatory and Intellectual Property teams work closely to advise NDA holders and patent owners on Orange Book patent submissions, along with related lifecycle strategies arising under the Hatch-Waxman regulatory and litigation framework.  Most recently, we wrote about the implications of the Supreme Court’s decision in the Hikma v. Amarin case regarding induced infringement in the “skinny labeling” context.  We will also be hosting a webinar in late July regarding FDA’s patent listing process.