FDA Orange Book
Is there a generic for Yondelis?
Yondelis contains trabectedin. 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 Yondelis (trabectedin). The Orange Book shows its last listed patent expires July 7, 2028.
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Yondelis products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 1MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 207953, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Yondelis patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8895557 | January 7, 2028 | Drug product | None | 207953 |
| 8895557*PED | July 7, 2028 | Method of use | None | 207953 |
Yondelis NDC codes
Questions
Is there a generic for Yondelis?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Yondelis (trabectedin). The Orange Book shows its last listed patent expires July 7, 2028.
What is the generic name for Yondelis?
The active ingredient in Yondelis is trabectedin, per the FDA Orange Book.
When does the Yondelis patent expire?
The last patent listed for Yondelis in the Orange Book expires July 7, 2028. 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.