Table. Characteristics of Generic Drugs Approved by the US Food and Drug Administration From July 2016 to December 2018.
| Characteristic | No. (%) |
|---|---|
| Generic competition at launch | |
| ≤2 Approvals | 374 (20.4) |
| ≥3 Approvals | 1458 (79.6) |
| Shortage within prior 5 y | |
| No | 1115 (60.9) |
| Yes | 717 (39.1) |
| Initial approval year | |
| Before 1984 | 414 (22.6) |
| 1984-1994 | 283 (15.4) |
| 1995-2004 | 761 (41.5) |
| 2005-2015 | 374 (20.4) |
| Priority review | |
| Standard | 1376 (75.1) |
| Priority | 456 (24.9) |
| Orphan drug statusa | |
| Standard | 1588 (86.7) |
| Orphan | 244 (13.3) |
| World Health Organization essential medicineb | |
| No | 1468 (80.1) |
| Yes | 364 (19.9) |
| Therapeutic area | |
| Alimentary tract and metabolism | 150 (8.2) |
| Cardiovascular system | 256 (14.0) |
| Dermatologic | 157 (8.6) |
| Genitourinary system or sex hormones | 151 (8.2) |
| Infectious disease | 229 (12.5) |
| Blood disease or cancer | 227 (12.4) |
| Nervous system or sensory organs | 426 (23.3) |
| Other | 236 (12.9) |
| Drug complexityc | |
| Noncomplex | 1481 (80.8) |
| Complex | 351 (19.2) |
a
Orphan status is designated to drugs that treat rare diseases or conditions, defined as affecting fewer than 200 000 people in the United States.
b
Includes medications considered to be most effective and safe to meet the most important needs in a health system.
c
A drug product was considered complex if specific attributes make it difficult to manufacture the drug or establish equivalence, such as complex active ingredients (eg, peptides, complex mixtures, naturally sourced) or complex formulations (eg, colloids or liposomes).