Incentives of obtaining Orphan Designation
| EU | US | |
| Market exclusivity | 10 years*1 | 7 years |
| Protocol assistance | Yes | Yes |
| Reduced regulatory fees | Yes | Yes |
| 50% tax credit on clinical trials | No | Yes |
| Dedicated subsidies for clinical trials | No | Yes |
* includes similar products for the same indication (unless significantly superior)
1 for orphan medicinal products for which the requirement for data on use in the paediatric population is fully met, the 10-year period of orphan market exclusivity is be extended to 12 years.