FDA Orange Book
Is there a generic for Defitelio?
Defitelio contains defibrotide. 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 Defitelio (defibrotide). The Orange Book shows its last listed patent expires June 22, 2032.
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Defitelio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 200MG/2.5ML (80MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 208114, held by JAZZ PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Defitelio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11236328 | June 22, 2032 | Method of use | U-3301 | 208114 |
| 11085043 | June 22, 2032 | Drug product | None | 208114 |
| 12529052 | June 22, 2032 | Drug product | None | 208114 |
| 11746348 | June 22, 2032 | Drug product | None | 208114 |
| 12534722 | June 22, 2032 | Drug product | None | 208114 |
Defitelio NDC codes
Questions
Is there a generic for Defitelio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Defitelio (defibrotide). The Orange Book shows its last listed patent expires June 22, 2032.
What is the generic name for Defitelio?
The active ingredient in Defitelio is defibrotide, per the FDA Orange Book.
When does the Defitelio patent expire?
The last patent listed for Defitelio in the Orange Book expires June 22, 2032. 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.