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Concerning generic products, if we conduct bioequivalence study, do
we infringe the data protection of the originator product (if this
data protection exist); please note that this BE will be used in the
preparation of the registration file to be submitted when exclusivity
Thank you for replying.
Neemat - Lebanon
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A generic drug has similar effects in terms of its rate and extent of
absorption of an approved product, which has to be proved by the
generic company. In other words the generic drug has similar effects
incuring a disease as the approved product. The generic approval
process is called Abbreviated New Drug application (ANDA).
While filing an ANDA, the generic company has to choose one of the
following four options (referred to as paras).
Para I - The drug has not been patented
Para II- The patent for the drug has already expired
Para III- The patent for the product exists but the generic company
wants to enter
the markets after the date of patent expiry passes.
Para IV- Patent is not infringed upon or is invalid.
In a Para III filing the company acknowledges the patent of the
approved drug and intends to enter the market after the patent for
the approved product expires. In Para IV filings the company claims
that the generic product of the company does not infringe upon the
existing patent or the patent of the branded product is invalid and
the company strives to win an exclusivity of 180 days during which
the margins for the product are very high.
Generally Generic manufacturer go for para III filing. Before
starting BE studies the company need to inform Regulatory bodies and
has to purchase refrence product from Innovator.
By these ways generic company does not infringe patent / data
Hope I answered your question properly.
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