Patent information is required to be submitted with all new drug applications (NDAs) and certain supplemental applications (sNDAs) on Form FDA 3542a at the time of submission of the NDA or sNDA.
Patent information for listing in the Orange Book must be submitted on Form FDA 3542 within 30 days following approval of an NDA or supplemental application. For patents issued after approval of the NDA or supplement, the NDA holder must submit the required patent information within 30 days of the issuance of the patent for it to be considered timely filed.
If the NDA holder timely submits the required patent information, but FDA notifies the NDA holder that its Form FDA 3542 is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the original submission of patent information. New patent information may still be submitted after 30 days of the issuance of the patent, but such information is not considered timely filed.
If patent information is untimely filed, generally a previously submitted ANDA or 505(b)(2) applicant is not required to submit a patent certification or statement to address the patent or patent information that is late-listed with respect to the pending ANDA or 505(b)(2) application.