How long does an applicant holder have to submit patent information?
Patent information is required to be submitted with all new drug applications at the time of submission of the NDA. If appropriate, the patent information is published at the time of approval of the NDA. For patents issued after approval of the NDA, the applicant holder has 30 days in which to file the patent to have it considered as a timely filed patent. Patents may still be submitted beyond the 30 day timeframe but the patent is not considered a timely filed patent. ANDA holders are not required to make a certification to an untimely filed patent if the generic application is submitted before the patent.
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