Orphan drug exclusivity

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Marketing exclusivity of seven years given to drugs under the Orphan Drug Act ("ODA") in order to encourage greater amounts of research into treatments for rare diseases. The concept behind the ODA is that the longer period of exclusivity will encourgage more companies to invest money in research. The ODA has been very successful - more than 200 drugs and biological products for rare diseases have been brought to market since 1983. In contrast, the decade prior to 1983 saw fewer than ten such products come to market.

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