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Number of orphan designations accepted in the United States 2003-2017

Accepted orphan designations in the United States from 2003 to 2017

The data shows the number of accepted orphan designations per year in the U.S. from 2003 to 2017. In 2008, there were 165 orphan designations accepted in the country. Orphan drugs are used to target rare diseases or disorders, which in the U.S. is defined as less than 200,000 patients. The development of orphan drugs are currently incentivized in the U.S. through the Orphan Drug Act of 1983.

2003 94
2004 132
2005 123
2006 141
2007 119
2008 165
2009 165
2010 192
2011 201
2012 189
2013 260
2014 289
2015 348
2016 320
2017 459