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What are Generic Drugs? - A Fact Sheet


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Generic Drugs
Generic Drugs
March 17, 2010- Information about generic drugs. Know the difference between generic drugs and brand name drugs.

A generic drug commonly known as generics is a drug that is manufactured and marketed without patent protection. A generic drug may have a patent on its formulation but not on the active ingredients used for making the drug.

What are Generic Drugs?

In simple terms, a generic drug is identical or equivalent in its composition to a brand name drug- it is the copy of an original drug. This is why, they are sometimes referred to as generic equivalents or brand name generic. The U.S. Food and Drug Administration (FDA) takes generic drugs as chemically identical drugs to brand name drugs in dose, strength, method of administration, safety, efficacy, and intended use.

How Generic Drugs are Made?

A new drug made by any pharmaceutical company has a patent protection which means that the particular drug can be made and sold by that pharma company only. When the patent or other periods of exclusive marketing for brand name drugs near their expiry date, pharmaceutical drug manufacturers can apply to the FDA to sell generic versions without repeating the original drug manufacturer's clinical trials. There are certain other conditions when a generic drug can be produced by generics manufacturers. For example, when the generics company proves that the patent for brand name drug is either invalid, unenforceable or will not be infringed upon when its generic equivalents are produced then it can produce a generic. Further, both brand name drugs as well as generic drugs facilities should meet the same standards of good manufacturing practices as FDA doesn't permit drugs to be made in substandard facilities.

What is the Difference Between Brand And Generic Drugs?

Generic drugs are equivalent to brand name drugs in their bioavailability and composition as well as strength, route of administration and effects. Brand name drugs have exclusive names on which the manufacturing pharmaceutical company holds patent and the name can not be copied by the other drug manufacturers. The difference between brand and generic drugs is only a minor one.
  • Generic drugs are not manufactured after any clinical research. As the brand name drugs company has already spent considerable time in research and trials, generics companies are not required to conduct any clinical research.
  • Cost of generic drugs are lower than brand name drugs. The price of a brand name drug may be three times higher than its generic equivalents. This is due to costs incurred on the clinical researches done by the original drug manufacturers and also the advertisement costs of the brand drugs.
  • Brand name drugs are produced by only that pharmaceutical company that holds its patent whereas generics are produced by many companies. This competition in generics is also one of the reasons for low costs of generic drugs.
  • Although generic drugs contain the same active ingredients as the original brand name drug, there can be slight differences in the inactive additives or fillers. For example, the way a drug is released in the system or the pill's shape may differ in both, the generic drugs and the original drugs.

This article is an attempt to convey information about generic drugs as to what are generic drugs as well as the difference between brand and generic drugs. For information on drugs as a whole go to Pharmaceutical Drugs



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