Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation

In 1983, the Orphan Drug Act was enacted to provide incentives for pharmaceutical companies to invest in developing prescription drugs targeting rare diseases, later defined as those affecting fewer than 200 000 US individuals. Congress justified providing extra market exclusivity and tax credits for orphan-designated drugs because small patient populations may produce insufficient sales to attract pharmaceutical investment.

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