Table 1 Definitions and sources used for market-, product- and disease-related characteristics of Orphan Medicinal Products (OMPs)
From: Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe?
Characteristic | Definitions | (Main) public source |
|---|---|---|
Market-related characteristics | ||
   prevalence | < 1 per 100,000 between 1 - 50 per 100,000 | Orpha.net (report series, Nov 2009) |
   annual turnover first OMP | maximum annual turnover of the first OMP | Sponsor documents |
   first OMP designated outside EU | first OMP obtained an orphan designation | FDA Orphan Drug |
| Â | inside and outside Europe | Product database |
   first OMP authorized outside EU | first OMP obtained marketing authorization | FDA Orphan Drug |
| Â | inside and outside Europe | Product database |
Product-related characteristics | ||
   pharmaceutical formulation | parenteral oral | EPARs |
Disease-related characteristics | ||
   disease class (ICD-10) | other ICD-10 classes C00-D48 (oncologic disorders) | Orpha.net |
   disease-specific scientific output | number of scientific publications in the period 1976-2008 in PubMed for a specific rare disorder | PubMed |
   inheritable disease | majority of cases caused by genetic inheritance | Orpha.net |
   chronic disease | disease duration is generally over 3 months | Orpha.net |
   childhood disease | majority of diagnosis before age 18 | Orpha.net |