An NDA holder must submit a correction or change to previously submitted patent information on a new Form FDA 3542. If an NDA holder determines that a patent or patent claim no longer meets the requirements for listing, the NDA holder must promptly notify FDA to amend the patent information or withdraw the patent or patent information and request that the patent or patent information be removed from the list. The NDA holder seeking to withdraw a patent must submit to its NDA a statement containing the NDA number to which the request applies, each product(s) approved in the NDA to which the request applies, and the patent number, and identify the submission as “Time Sensitive Patent Information.” If the NDA holder is required by court order to amend patent information or withdraw a patent from the list, it must submit an amendment to its NDA that includes a copy of the order, within 14 days of the date the order was entered. In addition, the NDA holder must submit a correction to the expiration date of the patent on Form FDA 3542 within 30 days after the grant of patent term extension.
