Generic-Drugs Technology, Study, Company, Consultancy, Patent, Process, Supplier, Report, Fact, Manufacture, Market, Guide, Economic, Stories

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Project at a Glance	Contents on the CD ROM
A generic drug is a drug which is produced and distributed without patent protection. A generic must contain the same active ingredients as the original formulation. A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Generic drugs are important options that allow greater access to health care for all Americans. Generic versions of a drug must use the same active ingredients as the brand name drug, and it must meet the same quality and safety standards. Generic drugs are pharmaceuticals with off-patent agents, which are brought to market in the classical form with the international non-proprietary name (INN). Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. A generic drug of biological type is different to chemical drugs because of its biological nature and it is regulated under extended set of rules for it. Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name. Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs. Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition. Generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties. Generic drugs can reduce healthcare costs through multiple pathways. Generic drugs cost much less than their branded counterpart, so the high rate of generic prescribing resulted in billions of dollars of savings for the U.S. health care system.	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