Orange Book Approved Drug Products

Electronic Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, [Internet]. URL http //www.fda.gov/cder/ob/default.htm, accessed 7-29-2000. 

Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations and any current supplement to the publication. 

The Electronic Orange Book Approved Drug Products with Therapeutic Equivalence Evaluations. US Department of Health and Human Services, PubUc Health Service, Food and Dmg Administration, Center for Dmg Evaluation and Research (CDER), Office of Information Technology, Division of Data Management and Services. http //www. fda.gov/cder/ob/default.htm... 

The reference standard in a bioequivalence study is a formulation currently marketed with an approved full NDA, for which there are valid scientific safety and efficacy data. The list of reference products is provided in the Orange Book ( Approved Drug Product with Therapeutic Equivalence Evaluations ). The reference product is usually the innovator s brand-name product. The total content of the active drug substance in the test product must be within 5% of the reference product. Usually similar routes of administration are used for the test and reference products unless an alternative route is needed to answer specific pharmacokinetic questions. In some cases the reference material could be a solution, suspension, IV product, or the clinical trial material containing the same quantity of active drug ingredient. 

Orange Book means the FDA s publication entitled Approved Drug Products with Therapeutic Equivalence, in which the patents claiming a drug product approved through an NDA are listed. 

The intermediate patents listed in the Orange Book present a category that may not literally claim the approved drug product. An intermediate patent claims a chemical compound that is used during the production of an active ingredient, but is not present in the final, marketed form of the drug product. The elaimed compound is an intermediate on the pathway to the approved drug. 

In an effort to codify bioequivalence information, the FDA publishes Approved Drug Products With Therapeutic Equivalence Evaluations, with monthly supplements, commonly called "the Orange Book." The book contains listings of multisource products in one of two categories Products coded "A" are considered bioequivalent to all other versions of that product with a similar "A" coding. Products not considered bioequivalent are coded "B." Of the approximately 8000 products listed, 90% are coded "A."... 

The FDA provides notice of the innovator s FDA and patent exclusivity by publishing information regarding exclusivity in the FDA Approved Drugs Product List (the Orange Book ). The Patent and Exclusivity Appendix to the list of approved products provides details regarding the expiry dates of all types of FDA exclusivity (including pediatric exclusivity) and the expiry dates of patents for each approved product. 

The relevant data exclusivity periods for each approved drug product, as well as any applicable patents on the product or its use, are listed in the Orange Book , which is published by the FDA and also available electronically on the FDA s web site. 

Bioequivalence studies are the basis for determination of the therapeutic equivalence between a pharmaceutically equivalent generic drug product and a corresponding reference hsted drug. This hst is provided in the book titled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. °... 

Codes are published by the FDA for every multisource product listed in the Orange Book (listing of the approved drug products). The two basic clas-sificationsinto which multi-sourcedmgshavebeen placed are indicated by the first letter of the code ... 

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