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[e-drug] Time of pseudogenerics appearing on market (cont'd)

E-drug: Time of pseudogenerics appearing on market (cont'd)

Pseudogenerics can appear on the market before the patent has
expired. How long independent generics take to reach the market
depends on a number of factors: 

-  whether or not there is any litigation between the company holding
   the patent and the generic company;
-  in the US/Canada patent holders can claim that their patent rights
   are being violated and merely by making that claim trigger up to a
   24 month (Canada) or a 30 month (U.S.) delay in the appearance
   of a generic;
-  regulatory requirements to prove bioequivalence;
-  Canada and the U.S. allow generic companies to begin producing
   drugs for the purpose of getting regulatory approval before the
   expiration of the patent (Bolar provision) whereas European
   countries do not have a Bolar provision.

Joel Lexchin MD
121 Walmer Rd.
Toronto Ontario
Canada M5R2 2X8
Tel:  416-964-7186
Fax:  416-923-9515
e mail: joel.lexchin@utoronto.ca
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