lurbinectedin · Jazz · NDA 213702
Zepzelca
Earliest generic entry, as listed
13 Dec 2029
Blocked by patent: US 7763615.
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7763615 | drug substance, drug product, use U-2836, U-4299 | 13 Dec 2029 |
| US 7763615 listing row | drug substance, drug product, use U-2836 · sets the listed date | 13 Dec 2029 |
| US 7763615 listing row | drug substance, drug product, use U-4299 · sets the listed date | 13 Dec 2029 |
Exclusivities · 2 unexpired
| I-977 | new indication (3 years) | 2 Oct 2028 |
| ODE-304 | orphan drug (7 years) | 15 Jun 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213702 · 001 · RLD | powder, intravenous | 4MG/VIAL | 13 Dec 2029 |
Expired or delisted (3)
- US 12324806 · use U-4212 · 29 May 2040 · delisted
- US 12433890 · use U-4305 · 29 May 2040 · delisted
- US 12440490 · use U-4252 · 29 May 2040 · delisted