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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.
(10) Orphan drug means a drug intended for use in a rare disease or condition as defined in section 526 of the act. (11) Orphan-drug designation means FDA's act of granting a request for designation under section 526 of the act.or purposes of the Orphan Drug Act, FDA considers the real party or parties in interest to be a sponsor.[57 FR 62085, Dec. 29, 1992, as amended at 64 FR 402, Jan. 5, 1999; 64 FR 56449, Oct. 20, 1999; 78 FR 35132, June 12, 2013].