FDA Orange Book
Is there a generic for Grafapex?
Grafapex contains treosulfan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Grafapex (treosulfan). The Orange Book shows its last listed patent expires October 12, 2026 and its last listed exclusivity ends January 21, 2032.
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Grafapex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 1GM/VIAL | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 5GM/VIAL | Marketed (Rx) | None | 0 | None |
NDA 214759, held by MEDEXUS PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Grafapex patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7199162 | October 12, 2026 | Method of use | U-4142 | 214759 |
Grafapex exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 21, 2030 | 214759 |
| ODE-513 | Orphan drug exclusivity | January 21, 2032 | 214759 |
| ODE-514 | Orphan drug exclusivity | January 21, 2032 | 214759 |
Grafapex NDC codes
Questions
Is there a generic for Grafapex?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Grafapex (treosulfan). The Orange Book shows its last listed patent expires October 12, 2026 and its last listed exclusivity ends January 21, 2032.
What is the generic name for Grafapex?
The active ingredient in Grafapex is treosulfan, per the FDA Orange Book.
When does the Grafapex patent expire?
The last patent listed for Grafapex in the Orange Book expires October 12, 2026. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.