Generic drug is a drug defined as “a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.” It has also been defined as a term referring to any drug marketed under its chemical name without advertising. A generic drug must contain the same active ingredients as the original formulation. 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, in EU and USA it is possible to extend protection by 5 years.
A generic drug of biological type (e.g. monoclonal antibodies), is different to chemical drugs because of its biological nature and it is regulated under extended set of rules for it. To learn more, see Biosimilars.