Orange Book Therapeutic Equivalence

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. 

The Bureau of Competition and Policy Planning Staff of the Federal Trade Commission ( FTC ) submit this Citizen Petition to the Commissioner of Food and Drugs pursuant to 21 C.F.R. 10.25(a) and 10.30 concerning certain issues relating to patent listings in the FDA s Approved Dmg Produets with Therapeutic Equivalence Evaluations (the Orange Book ). We request that the FDA clarify these issues, on an expedited basis, via industry guidanee or other means that the FDA considers appropriate. 

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. 

Of the more than 10,000 drugs in the Orange Book, approximately 80% are generic versions. Of the approximately 8,000 multisource generic drugs, more than 90% are considered therapeutically equivalent to the innovator s product. 

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 U.S. FDA s Orange Book uses a two-letter coding system that is helpful in determining which drug products are considered to be therapeutically equivalent. The first letter, either an A or a B, indicates a drug product s therapeutic equivalence rating. The second letter describes the dose forms and can be any one of a number of different letters. 

The B codes are a much less desirable rating when compared to the A codes. Products that are rated with a B code may still be commercially marketed however, they may not be considered therapeutically equivalent. The Orange Book describes B codes as follows ... 

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. 

When using the Orange Book, the term therapeutic equivalence refers to which of the following ... 

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