What is the primary purpose of the Orange Book?

The primary purpose of the Orange Book, officially known as the "Approved Drug Products with Therapeutic Equivalence Evaluations," is to identify therapeutic equivalence of drugs. This resource, published by the Food and Drug Administration (FDA), categorizes drug products into two main classifications: those that are therapeutically equivalent to their brand-name counterparts and those that are not. The therapeutic equivalence ratings help pharmacists and healthcare providers determine which generic drugs can be safely substituted for branded drugs, ensuring that patients receive medications that are both safe and effective. This is crucial for fostering competition in the marketplace, enhancing access to affordable medications, and providing healthcare practitioners with up-to-date information on the equivalence of drug formulations.