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 they spent developing
and testing the drug and not actually producing and
selling it.

They can also apply for 180 days exclusivity as the
first one to apply and be accepted to produce a
generic version of the original drug.

As well as this there is aggressive litigation against
those who try to produce generic versions in an
attempt to dissuade them; this is costly but not as
costly as the 80% or so price drop of their product
caused by additional competition.

The most common method of evergreening is updating
patents claiming some change in the product and
effectively resetting the clock.

Drug companies also patent every possible thing about
their drug from the colour, size, shape, taste
production method and even the form of compounds used
to make it in order to make it difficult for a company
to produce a generic which does not infringe these
trademarks and patents.

Many people have concerns over the safety and
effectiveness of Generic drugs as they don

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 safe and do the job they claim.

Generic Drugs are tested differently, as the clinical
trial information already exists for the original
drug; all the generic version has to prove is that it
contains safe ingredients and is bioequivalent (works
in the same way) as the original drug.

Bioequivalence is stated by the FDA to be: “the
absence of a significant difference in the rate and
extent to which the active ingredient or active moiety
in pharmaceutical equivalents or pharmaceutical
alternatives becomes available at the site of drug
action when administered at the same molar dose under
similar conditions in an appropriately designed
study.” (FDA, 2003)”.

This means it releases the same amount of the same
active ingredient over the same time scale as he
original drug.

Once an existing patent has run out the applicant
submits an ANDA or Abbreviated New Drug Application
and bioequivalence tests are carried out. Once
approved the new Drug is added to the Approved Drug
Products List along with its bio equivalence
standards.

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 the
brand name version? Possibly 50% of all generics are
made by the company which developed the original drug.

Are Generic drugs made in the same standard facilities
as brand drugs?

Yes all facilities must meet FDA standards.

Why do the branded and generic version of a drug look
different?

Trademark laws do not allow generic versions to look
like other drugs on the market so coloring, size and
shape etc may be different but they still act in the
same way as the difference is in the inactive
ingredients.

What is bioequivalence?

If a generic drug is bioequivalent to the original it
means the generic drug works in exactly the same way.
It releases the same amount of the same active
ingredient in to the blood stream over the same time
period as the original.

Why are generic drugs cheaper?

Due to increased competition between pharmaceutical
companies once a patent has been lifted on a
particular drug.

Where are generic drugs produced?

50% of all generic drugs continue to be produced by
the company, which held the original though at a lower
price due to competition. Some are made by developing
countries usually in cases where a drug is exempt in
that country from an existing patent in the West.

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 same
amount of active ingredient over the same time scale.

The differences often lie mostly in the presentation
of the drug for example a branded drug may produce
pills which have a nice colouring and flavour, whereas
the generic version will generally contain little more
than the active ingredient.

There should therefore be very little difference to
the patient between branded and generic drugs and both
have to go through the same regulators. Generics have
a few advantages however over the branded
alternatives.

The branded drug is often the first of it

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 versions of patented drugs to fill
this demand, the patent would still hold elsewhere
until expiration.

Some fear the drugs may be re-imported and sold back
to the west where seller would get a greater profit
rather than going to benefit those in need but strict
regulation that the drug be produced and imported for
humanitarian reasons only.

Another problem is ensuring prices remain low enough
for developing countries to afford, this requires a
market large enough to attract a large amount of
competition that will keep prices down.

There are many claims that large Pharmaceutical
companies are blocking efforts by countries such as
India to produce cheap generic versions of their
drugs. Drugs that are produced cheaply in these
countries are often imported to the west rather than
going to those in need in the countries of origin.

1 in 4 aids suffers have access to the HIV drugs they
need to stay alive and just 1 in 5 has access to basic
prevention services. There are currently 33,000,000
people living with HIV and AIDS.

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 on the other hand have huge expenses in
developing a new drug so often place huge profit
margins in order to make this money back before the
patent runs out, they don

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 get around
them by producing drugs which are do the same job but
different enough not to be affected by existing
patents.

Companies may also produce generic versions of a
patented drug in countries not covered by the patent.

Companies can apply for a 5-year extension to their
patent to make up for the time they were going through
the approval process.

They cannot however patent the active ingredient for
more than the length of the patent or renew patents
that have expired, though they can patent the inactive
ingredients and specific forms of compounds used.

Companies protect their product by patenting aspects
of their drug such as the size shape and colour of the
pill as well as the brand name, these patents do not
run out.

There is also what is known as a research exemption to
these patents, other companies can research and
develop their own generic versions of the drug whilst
the patent protection is still in place and so can
move fast to get their product onto the market once
the patent expires.

The first company to file an accepted abbreviated new
drug application (for a generic) can also gain a 180
day exclusivity to produce a sell their generic
version, this can be applied for by the original
innovator company as a way of prolonging their
exclusivity, though not using the original drug as
there have to be some differences to make it a
generic.

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 is just as tough.

Generic drugs are manufactured in exactly the same way
as the branded alternative and the facilities in which
they are produced must adhere to exactly the same
guidelines and regulations.

In fact 50% of generic drugs are produced by
companies, which also produce branded products.

Generic drugs look different to branded versions
because the look of the branded pill is often
patented, so the generic version although containing
exactly the same active ingredient differs in the
non-active components to make the drug look different.

The vast majority of drugs prescribed are generics.

Talk to your Doctor about the medication you are
prescribed if you have any concerns. They should be
able to give you accurate advice of the drug, its
effects and side effects; the important thing is to be
informed.

Generic drugs are cheaper than the original so reduce
medical bills significantly. Sometimes especially if
it is a new drug a generic version won

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 versions of patented drugs to fill
this demand, the patent would still hold elsewhere
until expiration.

Some fear the drugs may be re-imported and sold back
to the west where seller would get a greater profit
rather than going to benefit those in need but strict
regulation that the drug be produced and imported for
humanitarian reasons only.

Another problem is ensuring prices remain low enough
for developing countries to afford, this requires a
market large enough to attract a large amount of
competition that will keep prices down.

There are many claims that large Pharmaceutical
companies are blocking efforts by countries such as
India to produce cheap generic versions of their
drugs. Drugs that are produced cheaply in these
countries are often imported to the west rather than
going to those in need in the countries of origin.

1 in 4 aids suffers have access to the HIV drugs they
need to stay alive and just 1 in 5 has access to basic
prevention services. There are currently 33,000,000
people living with HIV and AIDS.