defibrotide sodium · Jazz Pharms Inc · NDA 208114
Defitelio
Earliest generic entry, as listed
22 Jun 2032
Blocked by patent: US 11085043, US 11236328, US 11746348, US 12529052, US 12534722.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11085043 | drug product · sets the listed date | 22 Jun 2032 |
| US 11236328 | use U-3301 · sets the listed date | 22 Jun 2032 |
| US 11746348 | drug product · sets the listed date | 22 Jun 2032 |
| US 12529052 | drug product · sets the listed date | 22 Jun 2032 |
| US 12534722 | drug product · sets the listed date | 22 Jun 2032 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208114 · 001 · RLD | solution, intravenous | 200MG/2.5ML (80MG/ML) | 22 Jun 2032 |