Table. Characteristics of Brand-Name Drugs With Full-Label and “Skinny-Label” First Generic Approvals, 2015-2019.
| Drug characteristic | Brand-name drugs, No. (%) | ||
|---|---|---|---|
| Susceptible to skinny labeling | With full-label generic drug | With skinny-label generic drug | |
| Total No. of brand-name drugs | 56 | 32 | 24 |
| Year of first generic approval | |||
| 2015 | 19 (34) | 14 (44) | 5 (21) |
| 2016 | 10 (18) | 6 (19) | 4 (17) |
| 2017 | 12 (21) | 9 (28) | 3 (13) |
| 2018 | 7 (13) | 2 (6) | 5 (21) |
| 2019 | 8 (14) | 1 (3) | 7 (29) |
| Brand-name label includes: | |||
| Pediatric population | 23 (41) | 8 (25) | 15 (63) |
| Supplemental indicationa | 34 (61) | 14 (44) | 20 (83) |
| >2 Indications/populations | 28 (50) | 14 (44) | 14 (58) |
| Net salesb in 1 y prior to first generic approval, in millions, US $ | |||
| <500 | 19 (34) | 10 (31) | 9 (38) |
| 500-2000 | 15 (27) | 10 (31) | 5 (21) |
| >2000 | 5 (9) | 0 | 5 (21) |
| Not available | 17 (30) | 12 (38) | 5 (21) |
a
Supplemental indication is a new use approved by the US Food and Drug Administration that was not included in the original brand-name drug approval.
b
Calculated by summing net sales for the 4 quarters before brand-name drug approval, using data from SSR Health. Two brand-name drugs in the cohort were referenced by both skinny-label and full-label generic drugs, and we categorized these as full labels only.