From Wikipedia,
the free encyclopedia
A generic drug (pl.
generic drugs, short: generics) is
a
drug which is
bioequivalent to a
brand name drug with respect
to
pharmacokinetic and
pharmacodynamic properties,
but is normally sold for a lower
price. Generic medicines must
contain the same active ingredient
at the same strength as the
"innovator" brand, be
bioequivalent, and are required to
meet the same
pharmacopoeial requirements
for the preparation. By extension,
therefore, generics are identical
in dose, strength, route of
administration, safety, efficacy,
and intended use.
The principal reason for the
reduced cost of generic medicines
is that these are manufacturered
by smaller pharmaceutical
companies which do not invest in
research and development into
new drugs. The significant
research and development costs
incurred by the large
pharmaceutical companies in
bringing a new drug to the market
is often cited as the reason for
the high cost of new agents - they
wish to recover these costs before
the patent expires. Generic
manufacturers do not incur these
costs, with bioequivalence testing
and the actual manufacturing
process costing relatively little,
and are able to charge
significantly less than the
"innovator" brand.
Generics can be legally
produced for drugs where: 1) the
patent has expired, 2) the
generic company certifies the
brand company's patents are either
invalid, unenforceable or will not
be infringed, 3) for drugs which
have never held patents, or 4) in
countries where a patent(s) is/are
not in force. The expiration of a
patent removes the monopoly of the
patent holder on drug sales
licensing. It is also becoming
popular for the large
pharmaceutical companies to
preempt the expiry of their patent
by producing their own generic
product, or license their own
product to be branded by generic
companies. Thus, in some cases,
the "generic" product is actually
the brand product but inside a
different box.
Patent lifetime and research
cost issues
Pharmaceutical companies may
produce a generic drug when the
patent expires on the innovator
drug.
Patent lifetime differs from
country to country. The length of
time before a patent expires
varies for different drugs.
Usually, there is no way to renew
a patent after it expires. A new
version of the drug with
significant changes to the
compound could be patented but
this will require new clinical
trials and will not prevent the
generic versions of the original
drug. Usually, generic drugs are
much less expensive than the
brand-name product. Some
patients and physicians will
hesitate to prescribe these
medications because of concerns
about the quality of generic
drugs. In most cases, the only
differences between the brand-name
product and the generics are the
price and the name. When a
pharmaceutical company first
markets a drug, it is usually
under a patent that only allows
the pharmaceutical company that
developed the drug to sell it.
This allows the company to recoup
the cost of developing that
particular drug. It costs on
average around 800 million dollars
to develop and test a new drug
before it is approved for use.
After the patent on a drug
expires, any pharmaceutical
company can manufacture and sell
that drug. Since the drug has
already been tested and approved,
the cost of simply manufacturing
the drug will be a fraction of the
original cost of testing and
developing that particular drug.
The brand-name drug companies have
tended to litigate aggressively to
extend patent protection on their
medicines and keep generic
versions off the market, a process
referred to by critics as "evergreening."
Ensuring bioequivalence
In the
USA the
Food and Drug Administration
(FDA) is responsible for making
sure that generic drugs are safe
and effective. The approval
process for generic drugs began in
the late 1960s. Generic drug
manufacturers were required to
prove that their formulation
exhibits
bioequivalence to the
innovator product. Over the past
several years there have been
studies that have proven without a
doubt that
generic drugs are safe and
effective. Generic drugs are
always less expensive and can save
patients and insurance companies
thousands of dollars without
compromising the quality of care.
The FDA must approve generic drugs
just as innovator drugs must be
approved.
