|
A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to a brand/reference listed drug product in dosage form, strength, quality and performance characteristics, and intended use."〔("Generic Drugs" ), Center for Drug Evaluation and Research, U.S. Food and Drug Administration〕 It has also been defined as a term referring to any drug marketed under its chemical name without advertising〔(www.medterms.com: definition of generic drug )〕 or to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold.〔(Definition of generic drug )〕 Although they may not be associated with a particular company, generic drugs are subject to the regulations of the governments of countries where they are dispensed. Generic drugs are labeled with the name of the manufacturer and the adopted name (nonproprietary name) of the drug. A generic drug must contain the same active ingredients as the original formulation. According to the U.S. Food and Drug Administration (FDA), generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA's use of the word "identical" is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In most countries of the world, patents give 20 years of protection. However, many countries/regions, e.g. the European Union and the USA may grant up to 5 years of additional protection for drugs ("patent term restoration") if manufactures meet specific goals such as conducting clinical studies for pediatric patients. Manufacturers, wholesalers, insurers, and drugstores can each increase prices at various stages of production and distribution.〔 According to the GPhA/IMS September 2011 annual savings analysis, generic drug usage in the United States "generated $158 billion in health care savings in 2010 alone, a remarkable rate of $3 billion every week."〔 777 6th Street, NW〕 Prescriptions may be issued for drugs specifying only the chemical name, rather than a manufacturer's name; such a prescription can be filled with a drug of any brand meeting the specification. For example, a prescription for lansoprazole can be filled with generic lansoprazole, Prevacid, Helicid, Zoton, Inhibitol, or Monolitum. Biopharmaceuticals such as monoclonal antibodies are different from small molecule drugs because of their biological nature. Generic versions of these drugs, known as biosimilars, are typically regulated under an extended set of rules. ==Nomenclature== Generic drug names are constructed using standardized affixes that separate the drugs between and within classes and suggest the action of the drug. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Generic drug」の詳細全文を読む スポンサード リンク
|