Orange Book product · Brand (NDA)
EXBLIFEP
CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
At a glance
Feb 22, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 22, 2024
2 yr 4 mo ago
Today
Patent 7687488 expires
Listed drug substance patent expiration.
Dec 03, 2027
in 1 yr 6 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 22, 2029
in 2 yr 9 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Feb 22, 2034
in 7 yr 10 mo
Patent 11124526 expires
Listed method-of-use patent (U-3852) expiration.
Nov 07, 2034
in 8 yr 6 mo
Pharmaceutical detail
Active ingredient
CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Strength
EQ 2GM BASE/VIAL;0.5GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 216165
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
Feb 22, 2029
in 2 yr 9 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Feb 22, 2034
in 7 yr 10 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7687488 | Dec 03, 2027 | in 1 yr 6 mo | SubstanceProductU-3851 |
| 11124526 | Nov 07, 2034 | in 8 yr 6 mo | U-3852 |
