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Sunday, October 31, 2010

What is a generic drug

What is a generic drug (generic drugs, short form : generics) :

Pharmaceutical or Drug is considered as a generic drug , where it is not protected by patent protection .It is possible that a generic drug have a patent on the formulation but not on the active ingredient, in such case formulation can not be taken by any one but the active ingredient can be formulated so as to form a suitable dosage form.
A generic Drug or Pharmaceutical should contain the same active ingredients as that of the original or parent formulation.
According to the U.S. Food and Drug Administration (FDA),Generic Pharmaceuticals or generic drugs are identical to or acceptable within an bioequivalent range with respect to pharmacokinetic and pharmacodynamic properties of the to the branded pharmaceutical product. Hence, Generic Pharmaceuticals or generic drugs are considered by US FDA as drugs identical in dose, strength, route of administration, safety, efficacy, and intended use.

US FDA establishes required standards for a generic drug giving a range of acceptable values and range of variations that a generic drug is required to be bioequivalent to a brand name drug .

Generic drugs is likely to differ from original brand name drug with respect to inactive ingredients or excipients, its configuration, release mechanisms, packaging shape , scoring.

In the US, drug patents grant twenty years of protection.

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