FDA Orange Book · active-ingredient family
Treosulfan
Treosulfan is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:GRAFAPEX · NDA 214759
1
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
6
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GRAFAPEXRLD×2 | MEDEXUS | NDA 214759 | — | Jan 21, 2025 |
Marketing exclusivity (6)
- 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
- 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 |
Treosulfan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
