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An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease.n average the cost per patient for orphan drugs is six times that of non-orphan drugs, a clear indication of their pricing power.. Partly as a result of the 1983 US Orphan Drug Act, Japan adopted it in 1993 as did the European Union in 2000.
Rebif overturned Avonexâs orphan drug exclusivity (7 MAR 2002) EU: 10 Years of marketing exclusivity from approval Reduced R&D Costs Methodology on Classifying an Orphan Drug We have identified all products that have orphan drug designations filed in the US, EU or Japan.rior to the 1983 Act, 38 orphan drugs were approved. To date, 468 indication designations covering 373 drugs have been approved.The success of the original Orphan Drug Act in the US led to it being adopted in other key markets, most notably in Japan in 1993 and in the European Union in 2000.