Table 1.
Characteristics of 170 novel off-patent drugs approved by the Food and Drug Administration (FDA) and lacking generic competition in the USA
| Drug characteristic | FDA approved drugs* | ||||
|---|---|---|---|---|---|
| Total (n=170) | 0 generic versions (n=44) | 1 generic version (n=47) | 2 generic versions (n=41) | 3 generic versions (n=38) | |
| Approved for rare disease† | |||||
| Orphan status designation | 23 (33) | 12 (60) | 4 (22) | 1 (8) | 6 (32) |
| No designation | 47 (67) | 8 (40) | 14 (78) | 12 (92) | 13 (68) |
| WHO Essential Medicine‡ | |||||
| Included | 38 (22) | 14 (32) | 8 (17) | 6 (15) | 10 (26) |
| Not included | 132 (78) | 30 (68) | 39 (83) | 35 (85) | 28 (74) |
| Treatment class | |||||
| Autoimmune or musculoskeletal | 13 (8) | 5 (11) | 2 (4) | 2 (5) | 4 (11) |
| Cancer | 16 (9) | 9 (20) | 3 (6) | 1 (2) | 3 (8) |
| Cardiovascular, diabetes, or hyperlipidemia | 33 (19) | 3 (7) | 10 (21) | 11 (27) | 9 (24) |
| Gastrointestinal | 19 (11) | 7 (16) | 4 (9) | 6 (15) | 2 (5) |
| Genitourinary | 12 (7) | 4 (9) | 4 (9) | 3 (7) | 1 (3) |
| Infectious disease | 22 (13) | 8 (18) | 7 (15) | 3 (7) | 4 (11) |
| Neurology | 16 (9) | 2 (5) | 3 (6) | 4 (10) | 7 (18) |
| Psychiatry | 22 (13) | 1 (2) | 8 (17) | 7 (17) | 6 (16) |
| Other | 17 (10) | 5 (11) | 6 (13) | 4 (10) | 2 (5) |
| Product complexity§ | |||||
| Complex | 22 (13) | 8 (19) | 5 (11) | 5 (12) | 4 (11) |
| Non-complex | 148 (87) | 36 (81) | 42 (89) | 36 (88) | 34 (90) |
| Median (IQR) Medicaid spending in 2015 (US$)¶ | 1 038 995 (229 052-4 307 314) | 691 207.5 (229 052-9 469 889) | 322 175 (97 865-2 601 182) | 1 219 333 (272 251.5-3 152 809) | 1 925 303 (649 931-5 261 405) |
Data are number (%) of drugs unless stated otherwise. IQR=interquartile range; WHO=World Health Organization.
Number of generic versions approved by the FDA for each brand name drug in the sample.
Orphan status designation (attributed to drugs that treat rare diseases) began in 1983, so the number of orphan versus non-orphan status designated drugs differs from the total number of drugs.
WHO’s Model List of Essential Medicines includes drugs considered fundamental for any healthcare system.
A drug is considered a complex product if specific attributes make it difficult to manufacture the drug or establish bioequivalence, such as complex active ingredients (eg, peptides, complex mixtures, naturally sourced) or complex formulations (eg, colloids or liposomes).
The Medicaid state drug utilization database was used to determine spending by that program in 2015 for each drug in the study sample.