Once a patent has expired there should be very little
to stop companies producing generic versions of the
original drug.
However companies invest a lot in developing new drugs
so try to extend their exclusivity as long as possible
in a process known as evergreening.
They can in some cases apply for a 5-year extension to
their patent to cover the time [...]

Many people have concerns over the safety and
effectiveness of Generic drugs as they don
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The process of approving a generic drug was simplified
by the introduction of the Drug Price and Patent Term
Restoration Act of 1984 more commonly known as the
Hatch-Watchman Act after its main sponsors.
Generic Drugs are approved, as with all drugs in
America by the FDA or Food and Drug Administration.
Innovator Drugs undergo lengthy clinical testing to
ensure they are [...]

What is a generic Drug?
A Generic drug is produced once the patent of a new
drug has expired. It is the same as the original in
virtually everyway.
How are generic drugs regulated?
Generic drugs are regulated by the FDA and must be
tested and approved by them before production and
afterwards.
Is my generic drug made by the same company as [...]

Generic drugs do not differ greatly from their branded
equivalents. All drugs are carefully regulated in
exactly the same way to ensure they contain the
correct amount of active ingredient as well as
suitable inactive ingredients and are produced and
manufactured in a similar way.
The generic drug must be shown to be bioequivalent to
the branded alternative i.e. releases exactly the [...]

Third world countries are often the most in need of
new medicines but patents prevent the production of
cheap generics, which could be one way of supplying
this demand.
As a solution the World Trade Organisation (WTO)
introduced legislation in 2003 which would allow third
world countries to let them know which medications
they require and allow companies compulsory licences
to produce generic [...]

Generic drugs are cheaper for a number of reasons. The
expiry of a patent allows free competition, which
immediately lowers the price.
Many different companies can now produce the drug and
compete to sell it, so they want to get the production
costs and profit margins down as low as possible
whilst still retaining profitability in order to
undercut their rivals.
Patent holders [...]

Why are there generic drugs, surely all drugs are
patented by those who develop them?
Patents for drugs generally last for 20 years however
they are taken out early in the development process
and with lengthy animal then human clinical trials it
can take a decade or more from getting the patent to
going into production.
Other companies may challenge patents or [...]

Yes is the answer, generic drugs must show that they
are bioequivalent to the original.
They release just as much active ingredient in to the
blood stream over exactly the same time period in
other words they work exactly the same as the original
in every way.
The regulation and safety of generic drugs is just as
rigorous as branded drugs and [...]

Third world countries are often the most in need of
new medicines but patents prevent the production of
cheap generics, which could be one way of supplying
this demand.
As a solution the World Trade Organisation (WTO)
introduced legislation in 2003 which would allow third
world countries to let them know which medications
they require and allow companies compulsory licences
to produce generic [...]