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