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 |