FDA Orange Book
Is there a generic for Zepzelca?
Zepzelca contains lurbinectedin. 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 Zepzelca (lurbinectedin). The Orange Book shows its last listed patent expires May 29, 2040 and its last listed exclusivity ends October 2, 2028.
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Zepzelca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 4MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 213702, held by JAZZ PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zepzelca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7763615 | December 13, 2029 | Drug substance, Drug product | U-4299 | 213702 |
| 7763615 | December 13, 2029 | Drug substance, Drug product | U-2836 | 213702 |
| 12324806 | May 29, 2040 | Method of use | U-4212 | 213702 |
| 12433890 | May 29, 2040 | Method of use | U-4305 | 213702 |
| 12440490 | May 29, 2040 | Method of use | U-4252 | 213702 |
Zepzelca exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-304 | Orphan drug exclusivity | June 15, 2027 | 213702 |
| I-977 | New indication | October 2, 2028 | 213702 |
Zepzelca NDC codes
Questions
Is there a generic for Zepzelca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zepzelca (lurbinectedin). The Orange Book shows its last listed patent expires May 29, 2040 and its last listed exclusivity ends October 2, 2028.
What is the generic name for Zepzelca?
The active ingredient in Zepzelca is lurbinectedin, per the FDA Orange Book.
When does the Zepzelca patent expire?
The last patent listed for Zepzelca in the Orange Book expires May 29, 2040. 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.