A brand name drug is the version of the drug that is first
produced after approval by the FDA. The brand name of the drug
is a registered trademark and is marketed and sold under this
name. Alongside the trademark registration, most pharmaceutical
companies obtain a patent for their new drug to prevent other
companies from producing the drug. This patent protection gives
the company sole rights to the drug for 20 years.
When a patent expires other companies are then allowed to create
their own version of the drug. This version of the drug is
called a generic drug. Generic drugs are identical to the brand
name drug that it is related to and so therefore contains the
same active ingredients as the brand name drug. The quality,
safety and efficacy are also identical. Generic drugs may,
however, contain various different inactive ingredients such as
different coloring agents and preservatives which do not
obviously have a therapeutic effect. The brand name drug also
has inactive ingredients to create the tablet shape and color,
for example, and the reason why the generic inactive ingredients
differ is so that the generic pill produced does not infringe on
any trademark laws. This explains why generic pills look
different from the parent brand name drug. They are however in
effect exactly the same with regards to their active ingredients.
The FDA inform us that the generic equivalent of a brand name
drug may differ in: * Shape * Release mechanisms * Packaging *
Color * Flavor * Preservative * Expiration date/time * Labeling
aspects
FDA laws for Generic Drugs * A Generic drug cannot be
approved if it does not have an FDA approved brand name drug *
Generic drugs should follow the same dosage as that of original
drug * Generic drugs must be bio equivalent to the brand name
drug * The pharmaceutical company must write down the drug's
chemistry and quality control measures. Each step must be
written in detail while giving it for FDA review * The FDA
reviews the active and inactive ingredients in the generic drug
* The FDA reviews the labeling of generic drugs * The FDA
continuously reviews and monitors the generic drug's quality
after approval
Safety of Generic Drugs
Generic drugs are just as safe as brand name drugs and you are
to expect the same risks and benefits as the brand name drug.
The clinical and pharmacological effects are the same. This is
of course if the generic drug has been approved by the FDA. The
FDAQ carries out studies on any generic drugs to ascertain that
they are in fact as effective as the parent brand name drug.
The Price of Generic Drugs
Consistently generic drugs are cheaper than brand name drugs
because the investment and research costs that were needed to be
done in order to create the brand name drug have already been
completed. Therefore a company creating a generic drug can
afford to sell the finished product for less. Generic drug
prices are usually 30 - 80% cheaper than the original brand name
drug.
The Quality of Generic Drugs
There is no compromise at all on the quality of generic drugs,
the FDA would not allow that. Both brand drugs and generic drugs
must maintain the same production standards of Goog
Manufacturing Practice ( GMP ). In fact 50% of all prescriptions
within the USA and approx 40% in Canada are generic drug
prescriptions. That is proof in itself that buying generic drugs
is just as safe.
Things to Remember about Generic Drugs
* Generic drugs are not inferior to brand name drugs * Generic
drugs have a B rating but in no way does that mean they are a
lesser form of the drug * Follow your doctors advice as he/she
may have reason to prescribe a brand name drug over a generic
drug * Generic drugs do not take longer to work * Not all
medicines are available in generic form * The FDA ensure that no
generic drugs are sub standard drugs * Be aware that generic
drugs may look different to the parent brand name drug
and Finally...
It seems that consumers always confuse the effectiveness and
safety of a generic drug in comparison to the brand name drug
because the original brand name drug has a higher price.
However, rest assured that the generic drug has exactly the same
active ingredients and so perhaps saving money on your
prescription and non prescription is easier than you think.
About the author:
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