Defibrotide sodium
As of the edition of 20 October 2026, Defibrotide sodium is an oligonucleotide: marketed, first approved in 2016 (US); acts on PLG; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Oligonucleotide
- Brand name
- Defitelio
- First approved
- 30 March 2016 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Nippon Shinyaku; 2 holders in all
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Defibrotide sodium.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PLG | Plasminogen [Cleaved into: Plasmin | P00747 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Jazz Pharmaceuticals | Originator | 2016 to now |
| Nippon Shinyaku | Applicant | 2019 to now |