FDA issues guidance on sharing potential NDA patent information
The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and NDA holders on submitting patent information to their NDAs using Form FDA 3542a or Form FDA 3542. The guidance is intended to help applicants and holders submit patent information using the correct form to their NDA and aims to answer commonly asked questions.
A Form FDA 3542a is submitted when an NDA applicant submits information on a patent that claims a drug substance, drug product, or method of using the drug that is the subject of an unapproved original NDA, amendment to an NDA, or supplement to an NDA. A Form FDA 3542, on the other hand, is for NDA holders who submit the same information, but only for an approved NDA or an approved supplement to an NDA.
As part of their application, NDA applicants and holders are required to submit certain information for each claim where another entity may claim patent infringement. The proposed draft guidance addresses the information to include in the forms, where and when they should be submitted.
"Form FDA 3542a must be used when an NDA applicant submits information on a patent that claims a drug substance (active ingredient), drug product (formulation or composition), or method of using the drug that is the subject of an unapproved original NDA, amendment to an NDA, or supplement to an NDA," said FDA. "Form FDA 3542 must be used when an NDA holder submits information on a patent that claims a drug substance (active ingredient), drug product (formulation or composition), or method of using the drug to that is the subject of an approved NDA or approved supplement to an NDA."
NDA applicants and holders are required to submit information, including the patent number and patent expiration date for each patent where a patent infringement could be claimed. They are also required to submit information on patents claiming a drug substance only if they are the subject of a pending or approved NDA or if they are the same active ingredient as that of a pending or approved NDA.
"For patents that claim only a polymorph that is the same as the active ingredient described by the NDA (i.e., patents that have no other basis for listing), the NDA applicant or NDA holder must certify in the required FDA declaration form that the NDA applicant or NDA holder has test data demonstrating that the drug product containing the polymorph will perform the same as a drug product described in the NDA," said FDA. "For patents claiming a drug product, the NDA applicant or NDA holder must submit information only on those patents that claim the drug product that is described in the pending or approved NDA.
"For patents claiming a method of use, the NDA applicant or NDA holder must submit information only on those patents that claim indications or other conditions of use for which approval is sought or has been granted in the NDA, and the NDA applicant or NDA holder must separately identify each pending or approved method of use and the related patent claim(s)," the agency added. "For approved NDAs, the NDA holder also must provide a description of each patented approved method of use (“use code”)."
The guidance states that the NDA holder must submit the required patent information to the Orange Book within 30 days of receiving an NDA or NDA supplement approval. If the patent is issued after the NDA is approved, the NDA holder must submit Form FDA 3542 within 30 days of the patent's issuance. If FDA finds errors or omissions in the Form FDA 3542, the NDA holder will have 15 days to refile the form after the agency issues a notification.
The guidance addresses questions about how and where to find the forms, how to fill them out, what the FDA does with the forms, and what the NDA holder or applicant should do with the patent information.
Stakeholders can comment on the guidance on www.regulations.gov under docket no. FDA-2026-D-2698 until 14 August.
