The FDA has issued new draft Q&A guidance (available here) on Forms FDA 3542a and FDA 3542, providing additional clarity on Orange Book patent listing practices that are critical for NDA sponsors. The guidance emphasizes the distinction between the two forms—Form FDA 3542a for pre-approval submissions during NDA review, and Form FDA 3542 for post approval submissions to support Orange Book listing—and is aimed at improving the completeness and accuracy of patent disclosures.
While the forms themselves include examples of compliant and deficient entries, FDA’s guidance goes further, addressing recurring issues that have led to rejected listings, including patent eligibility (e.g., polymorphs and methods of use), timing of submission, and certification requirements. Innovator companies should view this as a signal to revisit internal listing practices and ensure alignment with FDA’s clarified expectations to avoid delays or loss of Orange Book coverage.
