E-drug: Registration of nearly-off-patent drugs? (cont'd)
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Here in Canada generic companies are allowed to manufacture and
stockpile drugs before patent expiration and can also submit
applications for marketing before the patent has expired. However,
marketing can be blocked by the brand name company for up to 30
months after patent expiration. All the brand name company has to do
is claim that the generic company is violating a patent on the product
(even if the patent has expired). This action blocks the Health
Protection Branch (the Canadian equivalent of the US FDA) from
issuing marketing authorization.
Joel Lexchin MD
121 Walmer Rd.
Toronto, Ontario
CANADA M5R 2X8
Phone: (416)-964-7186
Fax: (416)-923-9515
e mail: joel.lexchin@utoronto.ca
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