Orange Book product · Brand (NDA)
ZEVTERA
CEFTOBIPROLE MEDOCARIL SODIUM
At a glance
Apr 03, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 03, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 03, 2029
in 2 yr 10 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Apr 03, 2034
in 7 yr 11 mo
Pharmaceutical detail
Active ingredient
CEFTOBIPROLE MEDOCARIL SODIUM
Strength
667MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 218275
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)
Apr 03, 2029
in 2 yr 10 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Apr 03, 2034
in 7 yr 11 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
