treosulfan · Medexus · NDA 214759
Grafapex
Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Jan 2032
Blocked by exclusivity: ODE-513, ODE-514.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 3 unexpired
| ODE-513 | orphan drug (7 years) | 21 Jan 2032 |
| ODE-514 | orphan drug (7 years) | 21 Jan 2032 |
| NCE | new chemical entity (5 years) | 21 Jan 2030 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214759 · 001 · RLD | powder, intravenous | 1GM/VIAL | 21 Jan 2032 |
| 214759 · 002 · RLD | powder, intravenous | 5GM/VIAL | 21 Jan 2032 |
Expired or delisted (1)
- US 7199162 · use U-4142 · 12 Oct 2026