Skip to main content

Table 2 FDA Orphan Drug Designations and Approvals. U.S. 1983–2007

From: Incentives for orphan drug research and development in the United States

Number of Designations Number of Sponsors Orphan Designations Orphan Designations per Sponsor NDA Approvals NDA Approvals per Sponsor NDA Approvals per Designation NME Approvals NME Approvals per Sponsor NME Approvals per Designation
1 509 509 1.0 48 0.09 0.09 18 0.04 0.04
2 140 280 2.0 40 0.29 0.14 20 0.14 0.07
3 61 183 3.0 28 0.46 0.15 7 0.11 0.04
4 33 132 4.0 12 0.36 0.09 4 0.12 0.03
5 14 70 5.0 8 0.57 0.11 5 0.36 0.07
6 8 48 6.0 9 1.13 0.19 8 1.00 0.17
7 11 77 7.0 24 2.18 0.31 10 0.91 0.13
8 7 56 8.0 16 2.29 0.29 3 0.43 0.05
9 3 27 9.0 10 3.33 0.37 3 1.00 0.11
10 or more 24 411 17.1 127 5.29 0.31 37 1.54 0.09
Total 810 1,793 2.2 322 0.40 0.18 115 0.14 0.06