FDA Orange Book · active-ingredient family
Ceftobiprole medocaril sodium
Ceftobiprole medocaril sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZEVTERA · NDA 218275
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEVTERARLD | ISTX | NDA 218275 | — | Apr 03, 2024 |
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.
Ceftobiprole medocaril sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
