An NDA holder must submit patent information when it seeks approval of a supplement to add or change the dosage form or route of administration, to add or change the strength or to change the drug product from prescription use to over-the-counter use.
For supplements that seek approval for other changes (for example, to change the formulation, to add a new indication or other condition of use, or to make any other patented change regarding the drug substance, drug product, or any method of use), the requirements for submitting patent information depend on whether the existing patent information in the Orange Book for the original NDA continues to claim the changed product:
• If one or more patents, for which information was properly submitted for the product approved in the original NDA, claim the changed product, then the applicant is not required to resubmit this patent information, and FDA will continue to list the patent information.
• If one or more patents, for which information was properly submitted for the product approved in the original NDA, no longer claim the changed product, the applicant must submit a request to remove the listed patent information at the time of the approval of the supplement.
• If one or more patents, for which information was not previously submitted, claim the changed product, the applicant must submit the patent information required under 314.53(c).The NDA holder also must submit patent information for any supplement if the description of the patented method of use in the Orange Book would change upon approval of the supplement.
