Table. Five-Year Net Sales for Newly Marketed Prescription Drugs, 2008-2016.
| Drug characteristics | Drugs, No. (%) | Sales, median (IQR), $, in millionsa | Adjusted mean ratio (95% CI)b | P value |
|---|---|---|---|---|
| All drugs | 315 | 806 (252-2012) | ||
| Orphan designation for first approved indication | ||||
| No | 232 (74) | 812 (228-2351) | [Reference] | |
| Yes | 83 (26) | 719 (298-1771) | 0.6 (0.3-1.1) | .09 |
| Novelty | ||||
| Reformulation | 116 (37) | 459 (105-1108) | [Reference] | |
| Novel active ingredient | 199 (63) | 1184 (427-2934) | 2.3 (1.4-3.8) | .001 |
| Ingredient type | ||||
| Biologic | 73 (23) | 1122 (247-2525) | [Reference] | |
| Small molecule | 242 (77) | 733 (265-1908) | 1.4 (0.7-2.9) | .40 |
| Approval pathway | ||||
| Traditional approval | 283 (90) | 723 (216-1939) | [Reference] | |
| Accelerated approval | 32 (10) | 1368 (622-3910) | 2.1 (0.8-5.5) | .11 |
| Indication | ||||
| Nononcology | 260 (83) | 706 (210-1911) | [Reference] | |
| Oncology | 55 (17) | 1322 (590-2956) | 1.4 (0.7-3.0) | .33 |
| Route of administration | ||||
| Oral | 175 (55) | 905 (343-2591) | [Reference] | |
| Injected | 103 (33) | 1048 (273-2333) | 1.2 (0.6-2.3) | .66 |
| Other | 37 (12) | 241 (48-728) | 0.3 (0.1-0.6) | .001 |
| Year first marketed (per year)c | 1.0 (0.9-1.1) | .63 |
Sales were obtained from SSR Health, which collects these data from public Securities and Exchange Commission filings. We verified missing values by directly searching these filings. Four drugs had no publicly reported net sales, in which case 0 was rounded to $0.1 for the log-transformed model. All sales were converted to 2021 dollars using the Consumer Price Index for All Urban Consumers.
Adjusted mean ratios are derived from the exponentiated estimate from the linear regression model of log-transformed net sales. This can be interpreted as a ratio of mean sales between each group and the reference. For example, mean net sales were 2.3 times higher for drugs containing novel active ingredients compared with reformulated drugs.
Year first marketed was included as a continuous variable in the model. The date of market entry was determined based on the first year a price was listed in SSR Health.