Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States
Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), as required by the
Drug Price and Competition Act (Hatch-Waxman Act).
The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
# inducing pioneering research and development of new drugs and
# enabling competitors to bring low-cost, generic copies of those drugs to market'".
The Orange Book identifies
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
. The publication does not include drugs on the market approved only on the basis of safety (covered by the ongoing
Drug Efficacy Study Implementation Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US ...
ESIreview
'e.g.,''_Donnatal_Tablets_and_Librax.html" ;"title="Donnatal.html" ;"title="'e.g.,'' Donnatal">'e.g.,'' Donnatal Tablets and Librax">Donnatal.html" ;"title="'e.g.,'' Donnatal">'e.g.,'' Donnatal Tablets and Librax Capsules] or pre-1938 drugs [''e.g.,'' Phenobarbital Tablets]). The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or
efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versu ...
reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product.
In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource
prescription drug
A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription. The rea ...
products (
generic drug
A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active ch ...
s). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote
public education
State schools (in England, Wales, Australia and New Zealand) or public schools (Scottish English and North American English) are generally primary or secondary schools that educate all students without charge. They are funded in whole or in pa ...
in the area of drug product selection and to foster containment of
health care
Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health profe ...
costs.
[Orange Book preface]
/ref> Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.
Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent, or that the patent is invalid, unenforceable, or that the generic product will not infringe the listed patent.
The Orange Book does not list biological products such as vaccine
A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...
s. These are listed in later-enacted Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, commonly known as the Purple Book.
The DrugPatentWatch website offers a "Free DrugPatentWatch Orange Book PDF Library" from which the public can download digital copies of every FDA Orange Book, from the 1st Edition in 1980 to the most recent (as of 2020).
References
Further reading
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External links
Orange book
Orange book archives
{{DEFAULTSORT:Approved Drug Products With Therapeutic Equivalence Evaluations
Food and Drug Administration