Orange Book product · Brand (NDA)
GRAFAPEX
TREOSULFAN
At a glance
Jan 21, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 21, 2025
1 yr 5 mo ago
Today
Patent 7199162 expires
Listed method-of-use patent (U-4142) expiration.
Oct 12, 2026
in 4 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 21, 2030
in 3 yr 8 mo
Exclusivity ends · ODE-513
Orphan-drug exclusivity (7 years)
Jan 21, 2032
in 5 yr 8 mo
Exclusivity ends · ODE-514
Orphan-drug exclusivity (7 years)
Jan 21, 2032
in 5 yr 8 mo
Pharmaceutical detail
Active ingredient
TREOSULFAN
Strength
5GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214759
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (3)
- NCENew chemical entity exclusivity (5 years)
Jan 21, 2030
in 3 yr 8 mo
- ODE-513Orphan-drug exclusivity (7 years)
Jan 21, 2032
in 5 yr 8 mo
- ODE-514Orphan-drug exclusivity (7 years)
Jan 21, 2032
in 5 yr 8 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7199162 | Oct 12, 2026 | in 4 mo | U-4142 |
