Orange Book product · Brand (NDA)
RAPIBLYK
LANDIOLOL HYDROCHLORIDE
At a glance
Nov 22, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 22, 2024
1 yr 7 mo ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Feb 13, 2029
in 2 yr 8 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 22, 2029
in 3 yr 6 mo
Patent 10722516 expires
Listed method-of-use patent (U-4235) expiration.
Apr 25, 2034
in 8 yr
Pharmaceutical detail
Active ingredient
LANDIOLOL HYDROCHLORIDE
Strength
EQ 280MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 217202
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)
- NPPNew patient population exclusivity (3 years)
Feb 13, 2029
in 2 yr 8 mo
- NCENew chemical entity exclusivity (5 years)
Nov 22, 2029
in 3 yr 6 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10722516 | Apr 25, 2034 | in 8 yr | U-4235 |
