The FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book,” includes information about patents or exclusivities that apply to a particular drug product approved under the Federal Food, Drug, and Cosmetic Act (the Act). Patents and exclusivities are two different forms of protection for qualifying drug products that may affect how and when certain generic versions of those drug products are approved.
To read more, please visit: CDER Conversations.
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