Approved Drug Products with Orange Book

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 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. 

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."... 

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... 

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. °... 

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. 

In 8 instances, brand-name companies have listed later-issued patents in the Orange Book after an ANDA has been filed for the drug product. For the 8 dmg products, the additional delay of FDA approval (beyond the first 30 months) ranged from 4 to 40 months. In all of the 4 eases so far with a court decision on the validity or infiingement of a later-issued patent, the patent has been found either invalid or not infringed by the ANDA. 

From a commercial standpoint. The Orange Book is significant in two ways (1) it identifies generic competitors (if any) for branded products in the United States, and (2) it provides market exclusivity and patent expiration data associated with new drug approvals. Both of these factors are important in assessing company and product vulnerability. 

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