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The Orange Guide additionally lists patents broadly outlined as overlaying drug substances, drug products, and methods of use. Process patents are usually not permitted, except they are often considered intermediate patents that fall within FDA's definition of an energetic ingredient. However, for a single drug there are sometimes multiple patents for numerous aspects of the drug, similar to polymorphs, metabolites, pro-medicine, isomers, anhydrates and hydrates, as well as varied salt forms.55 If a generic applicant disputes the relevancy or accuracy of such a listed patent, the applicant can notify FDA, stating the grounds for this belief. Until the NDA holder voluntarily agrees to withdraw or amend the data, the FDA is not going to take away the patent. At this point the FDA cannot act further, and the generic firm should proceed by means of authorized channels.
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