Table VII.
Distribution of regulatory application type by classification types within reformulation cases
| Designation change | Approval time | Marketing Authorization | Patent expiry | Company | Brand name | Reformulation group | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Application type | No change | Orphan drugs | Non orphan | Orphan to orphan | Before 1999 | 1999–2008 | After 2008 | Before MA | After MA | Before PE | After PE | Same company | Different company | Same brand | Different brand | Group 0 | Group 1 | Group 2 | Group 3 |
| United States | 24 | 2 | 0 | 0 | 7 | 15 | 4 | 0 | 26 | 17 | 9 | 18 | 8 | 8 | 18 | 7 | 6 | 7 | 6 |
| NDA type 1 section 505(b) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NDA type 2 section 505(b) | 2 (8.3%) | 0 | 0 | 0 | 0 | 2 (13.3%) | 0 | 0 | 2 (7.7%) | 1 (5.9%) | 1 (11.1%) | 1 (5.6%) | 1 (12.5%) | 0 | 2 (11.1%) | 2 (28.6%) | 0 | 0 | 0 |
| NDA type 3 section 505 (b) | 12 (50.0%) | 2 (100.0%) | 0 | 0 | 6 (85.7%) | 7 (46.7%) | 1 (25.0%) | 0 | 14 (53.8%) | 10 (58.8%) | 4 (44.4%) | 11 (61.1%) | 3 (37.5%) | 5 (62.5%) | 9 (50.0%) | 1 (14.3%) | 4 (66.7%) | 4 (57.1%) | 5 (83.3%) |
| NDA type 3 section 505 (b)(2) | 3 (12.5%) | 0 | 0 | 0 | 1 (14.3%) | 2 (13.3%) | 0 | 0 | 3 (11.5%) | 2 (11.8%) | 1 (11.1%) | 1 (5.6%) | 2 (25.0%) | 1 (12.5%) | 2 (11.1%) | 1 (14.3%) | 1 (16.7%) | 1 (14.3%) | 0 |
| NDA type 4 section 505 (b) | 1 (4.2%) | 0 | 0 | 0 | 0 | 1 (6.7%) | 0 | 0 | 1 (3.8%) | 0 | 1 (11.1%) | 0 | 1 (12.5%) | 0 | 1 (5.6%) | 1 (14.3%) | 0 | 0 | 0 |
| NDA type 5 section 505(b) | 1 (4.2%) | 0 | 0 | 0 | 0 | 1 (6.7%) | 0 | 0 | 1 (3.8%) | 1 (5.9%) | 0 | 1 (5.6%) | 0 | 0 | 1 (5.6%) | 1 (14.3%) | 0 | 0 | 0 |
| NDA type 5 section 505(b)(2) | 2 (8.3%) | 0 | 0 | 0 | 0 | 2 (13.3%) | 0 | 0 | 2 (7.7%) | 1 (5.9%) | 1 (11.1%) | 1 (5.6%) | 1 (12.5%) | 0 | 2 (11.1%) | 1 (14.3%) | 1 (16.7%) | 0 | 0 |
| NDA type 6 section 505(b) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| sNDA (new indication) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| sNDA (new formulation) | 1 (4.2%) | 0 | 0 | 0 | 0 | 0 | 1 (25.0%) | 0 | 1 (3.8%) | 0 | 1 (11.1%) | 1 (5.6%) | 0 | 0 | 1 (5.6%) | 0 | 0 | 1 (14.3%) | 0 |
| sBLA | 2 (8.3%) | 0 | 0 | 0 | 0 | 0 | 2 (50.0%) | 0 | 2 (7.7%) | 2 (11.8%) | 0 | 2 (11.1%) | 0 | 2 (25.0%) | 0 | 0 | 0 | 1 (14.3%) | 1 (16.7%) |
| France | 15 | 0 | 0 | 2 | 8 | 7 | 2 | 0 | 17 | 13 | 4 | 13 | 4 | 8 | 9 | 5 | 3 | 3 | 6 |
| National | 9 (60.0%) | 0 | 0 | 0 | 7 (87.5%) | 2 (28.6%) | 0 | 0 | 9 (52.9%) | 8 (61.5%) | 1 (25.0%) | 8 (61.5%) | 1 (25.0%) | 4 (50.0%) | 5 (55.6%) | 3 (60.0%) | 3 (100.0%) | 1 (33.3%) | 2 (33.3%) |
| MR | 3 (20.0%) | 0 | 0 | 0 | 1 (12.5%) | 2 (28.6%) | 0 | 0 | 3 (17.6%) | 1 (7.7%) | 2 (50.0%) | 1 (7.7%) | 2 (50.0%) | 0 | 3 (33.3%) | 1 (20.0%) | 0 | 0 | 2 (33.3%) |
| Centralized | 3 (20.0%) | 0 | 0 | 2 (100.0%) | 0 | 3 (42.9%) | 2 (100.0%) | 0 | 5 (29.4%) | 4 (30.8%) | 1 (25.0%) | 4 (30.8%) | 1 (25.0%) | 4 (50.0%) | 1 (11.1%) | 1 (20.0%) | 0 | 2 (66.7%) | 2 (33.3%) |
| United Kingdom | 17 | 0 | 0 | 2 | 6 | 9 | 4 | 0 | 19 | 13 | 6 | 14 | 5 | 7 | 12 | 5 | 3 | 5 | 6 |
| National | 14 (82.4%) | 0 | 0 | 0 | 6 (100.0%) | 6 (66.67%) | 2 (50.0%) | 0 | 14 (73.7%) | 9 (69.2%) | 5 (83.3%) | 10 (71.4%) | 4 (80.0%) | 3 (42.9%) | 11 (91.7%) | 4 (80.0%) | 3 (100.0%) | 3 (60.0%) | 4 (66.7%) |
| MR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Centralized | 3 (17.6%) | 0 | 0 | 2 (100.0%) | 0 | 3 (33.3%) | 2 (50.0%) | 0 | 5 (26.2%) | 4 (30.8%) | 1 (16.7%) | 4 (28.6%) | 1 (20.0%) | 4 (57.1%) | 1 (8.3%) | 1 (20.0%) | 0 | 2 (40.0%) | 2 (33.3%) |
| Germany | 10 | 0 | 0 | 2 | 3 | 7 | 2 | 0 | 12 | 11 | 1 | 10 | 2 | 6 | 6 | 4 | 1 | 3 | 4 |
| National | 7 (70.0%) | 0 | 0 | 0 | 3 (100.0%) | 4 (57.1%) | 0 | 0 | 7 (58.3%) | 7 (63.6%) | 0 | 6 (60.0%) | 1 (50.0%) | 2 (33.3%) | 5 (83.3%) | 3 (75.0%) | 1 (100.0%) | 1 (33.3%) | 2 (50.0%) |
| MR | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Centralized | 3 (30.0%) | 0 | 0 | 2 (100.0%) | 0 | 3 (42.9%) | 2 (100.0%) | 0 | 5 (41.7%) | 4 (36.4%) | 1 (100.0%) | 4 (40.0%) | 1 (50.0%) | 4 (66.7%) | 1 (16.7%) | 1 (25.0%) | 0 | 2 (66.7%) | 2 (50.0%) |
MA, market authorization; PE, patent expiry; MR, Mutual Recognition.