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or an approved method of using the drug are currently listed in the Orange Book and recommends that FDA delist most secondary and all tertiary patents from the Orange Book, especially those patents that do not “claim the drug” or “methods of using the drug.”What is the FDA Orange Book?
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit comments on the listing of patent information in the FDA publication, “Approved Drug Products With Therapeutic Equivalence Evaluations” (commonly known as the “Orange Book”).When will the Orange Book drug listing and search results provide patent submission dates?
As of November 21, 2017, the Orange Book drug listing and search results will provide patent submission dates when available. This is in compliance with the final FDA rule that was part of the 2003 Medicare Modernization Act.What makes a product eligible to be in the Orange Book?
the FD&C Act. The main criterion for the inclusion of a product in the Orange Book is that it has an NDA or abbreviated new drug application (ANDA) that has been approved and that has not been withdrawn for safety or effectiveness reasons or determined by FDA to have been