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.

Generic Initiative for Value and Efficiency or GIVE is
an initiative by the Food and Drug Association to
bring more generic drug products to the market in
order to make safe cheap generic drugs more widely
available to the public.

Its aims are approve higher numbers of applications
and give priority to drugs for which there are few
generics available.

In order to do this the FDA need to streamline the
regulatory and approvals process in order to process
more applications and regulate pharmaceutical
companies more efficiently whilst still maintaining
high standards.

This is necessary due to the increasing volume of
applications and consequent expansion of the
association and its workload in recent years due to
the rate of advancement in medical science.

In an interview on GIVE the Director of the Office of
Generic Drugs Mr Buehler, RPh., stated how this was to
be achieved.

Q: How will the goals of GIVE be accomplished?

A: GIVE will work by combining our office’s various
efforts into one harmonized activity to implement
process improvements throughout the entire program.
The initiative is a review-oriented program that is
focused on three main areas:

- Mobilizing staff efforts to increase review
productivity.

- Optimizing the capacity and capability of all assets
within OGD, and leveraging wherever possible resources
from other FDA components.

- Using every avenue possible to recruit, hire and
train reviewers for our critical-need areas.