| Characteristic | Number of drugs |
|---|---|
| - | - |
| - | - |
| - | - |
| - | - |
| - | - |
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Source
Sources
Release date
December 2018
More information
Region
United States
Survey time period
as of November 2018
Number of respondents
503 respondents
Special properties
drugs with any approved orphan designation
Supplementary notes
ODE = orphan drug exclusivity.
Patent protection includes other forms of market exclusivity (e.g., pediatric extension, 505(b)(2)). The 101 therapies no longer
protected by either ODE or patent exclusivity did not have generic competitors as of June 2018. The 116 therapies no longer protected by either ODE or patent
exclusivity currently have one or more generic or biosimilar competitors in the market.
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