An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. In the U. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. According to the US Food and Drug Administration FDA, an orphan drug is defined as one intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than, persons in the United States. According to Thomson Reuters in their publication The Economic Power of Orphan Drugs, there has been increased investment in orphan drug research and development, partly due to the U.

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