Orange Book product · Brand (NDA)
ZEPZELCA
LURBINECTEDIN
At a glance
Jun 15, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 15, 2020
6 yr 1 mo ago
Today
Exclusivity ends · ODE-304
Orphan-drug exclusivity (7 years)
Jun 15, 2027
in 1 yr
Exclusivity ends · I-977
New indication exclusivity (3 years)
Oct 02, 2028
in 2 yr 4 mo
Patent 7763615 expires
Listed drug substance patent expiration.
Dec 13, 2029
in 3 yr 6 mo
Patent 7763615 expires
Listed drug substance patent expiration.
Dec 13, 2029
in 3 yr 6 mo
Patent 12324806 expires
Listed method-of-use patent (U-4212) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 12433890 expires
Listed method-of-use patent (U-4305) expiration.
May 29, 2040
in 14 yr 2 mo
Patent 12440490 expires
Listed method-of-use patent (U-4252) expiration.
May 29, 2040
in 14 yr 2 mo
Pharmaceutical detail
Active ingredient
LURBINECTEDIN
Strength
4MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 213702
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- ODE-304Orphan-drug exclusivity (7 years)
Jun 15, 2027
in 1 yr
- I-977New indication exclusivity (3 years)
Oct 02, 2028
in 2 yr 4 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7763615 | Dec 13, 2029 | in 3 yr 6 mo | SubstanceProductU-4299 |
| 7763615 | Dec 13, 2029 | in 3 yr 6 mo | SubstanceProductU-2836 |
| 12324806 | May 29, 2040 | in 14 yr 2 mo | U-4212 |
| 12433890 | May 29, 2040 | in 14 yr 2 mo | U-4305 |
| 12440490 | May 29, 2040 | in 14 yr 2 mo | U-4252 |
