What are “Orphan Drugs”?
Orphan products are drugs, biologics, or other therapeutics that treat diseases that affect fewer than 200,000 people in the United States.
What is the Orphan Drug Act of 1983?
The U.S. Orphan Drug Act (1983) gives incentives to pharmaceutical companies to develop drugs, biologics, or other therapeutics that will treat diseases that affect fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year exclusivity on product sales to induce companies to undertake the development and manufacturing of such product, which otherwise might not be profitable because of the small potential market. (Of the 5,000 diseases covered under the act, 47% affect fewer than 25,000 people.). The law has led to the introduction of over 200 valuable new products for the treatment of rare diseases.