Orange Book product · Brand (NDA)
TERLIVAZ
TERLIPRESSIN ACETATE
At a glance
Sep 14, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 14, 2022
3 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 14, 2027
in 1 yr 3 mo
Exclusivity ends · ODE-406
Orphan-drug exclusivity (7 years)
Sep 14, 2029
in 3 yr 3 mo
Patent 10335452 expires
Listed method-of-use patent (U-3711) expiration.
Apr 05, 2037
in 10 yr 11 mo
Pharmaceutical detail
Active ingredient
TERLIPRESSIN ACETATE
Strength
EQ 0.85MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022231
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)
- NCENew chemical entity exclusivity (5 years)
Sep 14, 2027
in 1 yr 3 mo
- ODE-406Orphan-drug exclusivity (7 years)
Sep 14, 2029
in 3 yr 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10335452 | Apr 05, 2037 | in 10 yr 11 mo | U-3711 |
