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.

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