Patient Population: Less than 200,000
Drugs (including biologics) for the prevention, diagnosis, or treatment of diseases or conditions affecting fewer than 200,000 persons in the US.
- 5,000: The number of new drugs granted ODD since 1983
- ~7,000: The number of different rare diseases known today, with many more to still be identified
- 7 years: The possible length of market exclusivity granted upon ODD approval.
- 25%: Potential to receive a 25% sponsor tax credit for some clinical trial costs for qualified testing.
Hereditary angioedema, cystic fibrosis, childhood acute lymphoblastic leukemia, and sickle cell anemia. Diseases in which the most significant advancements have been made since introduction of the Orphan Drug Tax Credit (ODTC).
- Oncology, neurology, and infectious diseases: Top three therapeutic areas impacted by ODD
- 33%: The percentage of drugs that would not receive ODD over the next 10 years without the ODTC
- 80: The number of products approved since establishment of the FDAʼs Orphan Products Grants Program
- >20: # of Orphan Drug Designations Syner-G has helped get granted by FDAʼs Office of Orphan Products Development (OOPD)
