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What are Generic Drugs ?
Generic drugs are referred to those
drugs that are recognized by their chemical name. When the
copyright of a particular brand name drug expires, the Food and
Drug Administration of the United States of America allows other
manufacturers besides the original, to create a bioequivalent
i.e. having the same active ingredients and following the same
standards, of the brand drug name and sell it to the public.
Generic drugs are generally much cheaper than the brands.
Why are generic drugs cheaper than
their brand counterparts ?
The obvious reason for the low cost is that the companies spend
considerably less amount of money in the production of the drug
and hence offers them at lower prices to the people.
The areas where these companies save
money are:
• Costs incurred due to the discovery, relevant research and
final development; they use the same ingredients as the existing
brands.
• Costs associated to the proving of the safety and
effectiveness of the medicine through the various clinical
trials.
• Finally they save a lot of money in the marketing of the drug
as the initial work has already been done by the innovator. Thus
their advertising costs come down to a great extent. This is one
of the reasons why generic drugs do not give away free samples
to promote their products.
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When can
a company produce generic drug ?
A company can legally produce generic drugs under the following
conditions:
• When the patent of the innovator expires
• When the generic company declares that the patent held by the
original company is invalid or will not be conflicted
• When the drugs have no patent at all
• In those countries where patent cannot be enforced
Expiration of the patent means cutting down the monopoly of the
pharmaceutical company. This is why many big companies preempt
the expiry of their patent by manufacturing generic products of
their own or even licensing their own products that are to be
branded by generic companies. In these situations, the generic
products are nothing but the brand products under a different
packing. |
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What do
you mean by the 180 day generic drug exclusivity ?
The FDA grants a period of 180 days to the generic drug
companies in some cases. During this tenure only one (or
sometimes a few) companies can manufacture the generic drug.
This situation arises when an objection is raised by the generic
company about the invalid patent of the parent company or when
the former convinces that the production of the generic version
will not affect the patent.
Are the generic drugs as safe as the
brand name drugs ?
Most certainly. Before the drugs hit the medical stores, they go
through a test conducted by the FDA which requires that all
drugs must be safe and effective. As the generic drugs use the
same compositions, they have the same advantages and drawbacks
as their branded counterparts.
Are they as strong as the branded
ones ?
According to the FDA rules, all the generic drugs must follow
the same standards and display the same quality, effectiveness,
purity and stability as the original ones.
It is often said that generic drugs takes longer time to work in
the body. Is this true?
This is a myth. All generic drugs function in the same way as
their parents and takes the same amount of time to work in the
body.
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Are the
brand named drugs manufactured in more advanced facilities than
their generic counterparts ?
No. According to the FDA, both brand names and generic drug
facilities must meet the same standards of good manufacturing
practises. A drug produced in inferior facilities and conditions
will not be permitted to be sold in the market. To ensure that
the standards are strictly met, the FDA conducts almost 3,5000
inspections in a year.
It has been seen that most of the big pharmaceuticals are
involved in generic drug production to cut competition. They
make copies of their own medicines and sell them without the
brand name.
If the generic drugs use the same
compositions as the branded ones, why do they look different
from one another ?
The United States of America trademark laws specifies that no
two drugs or medicines can look alike. So, even though the
active ingredients are the same, inactive ones like flavor and
color can be different. So, you will find that the generic drugs
differ in color and taste from the originals. |
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Is it
necessay that all the brand names must have a generic
coounterpart ?
No. When a company manufacturers a new drug, it is given a
patent protection for 20 years. This gives protection to the
drug manufacturer that has incured the initial costs like
research, development and finally the marketing expense. Once
the patent expires, other companies are given the license to
sell the competitive generic versions but only once they have
been thoroughly tested by the manufacturer and okayed by the
FDA.
How is an approval given to the
generic drugs ?
The generic drug companies must submit an abbreviated new drug
application or ANDA for approval in order to sell the generic
product. The ANDAs were made possible by the Hatch Waxman Act
(The Drug Price Competition and Patent Term Restoration Act of
1984) by creating a compromise in the drug industry. These
generic drugs became more common for prescription medications
and the original manufaturer gained restoration of patent life
of their drugs that was lost during the approval process
conducted by FDA.
Adhering to the standards or
ascertaining the bioequivalence
The FDA takes the responsibility to ensure that the generic
drugs manufactured are ‘safe and effective’. This process of
approval began in the later half of the 1960s when the generic
drug manufacturers were asked to prove that their preparation
displayed bioequivalence to the original product. Studies
conducted on these generic drugs have shown their effectiveness
and safety. Moreover, the cheaper cost of these drugs can make
them more accessible to patients and insurance companies can
save thousands of dollars without compromising on the quality.
Though the generic drugs start out at being fairly expensive,
the price reduces significantly as the production rate goes up.
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Article Contributed By: Sukanya
Banerjee
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