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AboutPricing
Drug ReportsCeftolozane
Zerbaxa(ceftolozane)
Zerbaxa (ceftolozane) is a small molecule pharmaceutical. Ceftolozane was first approved as Zerbaxa on 2014-12-19. It is used to treat bacterial infections, bacteroides infections, escherichia coli infections, intraabdominal infections, and klebsiella infections amongst others in the USA. It has been approved in Europe to treat bacterial infections.
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Drug
Target
Variants
Financial
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Events Timeline
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Combinations
Zerbaxa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ceftolozane sulfate
+
Tazobactam sodium
Tradename
Company
Number
Date
Products
ZERBAXACubist PharmaceuticalsN-206829 RX2014-12-19
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
zerbaxaNew Drug Application2024-11-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
intraabdominal infections—D059413—
pseudomonas infectionsEFO_0001076D011552A41.52
escherichia coli infectionsEFO_1001318D004927B96.20
streptococcal infectionsEFO_1001476D013290—
proteus infectionsEFO_1001130D011512—
klebsiella infectionsEFO_1001353D007710—
bacteroides infectionsEFO_1000832D001442—
Agency Specific
FDA
EMA
Expiration
Code
CEFTOLOZANE SULFATE / TAZOBACTAM SODIUM, ZERBAXA, CUBIST PHARMS LLC
2025-04-21NPP
2024-12-19GAIN
2019-12-19NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ceftolozane Sulfate / Tazobactam Sodium, Zerbaxa, Cubist Pharms Llc
101251492035-08-14DP
103764962034-09-09U-2610, U-2611
109330532034-09-09U-3090, U-3091
89068982034-05-28DS, DP
89687532034-03-14U-1672, U-1673, U-3360, U-3361
93207402034-03-14DP
98729062034-03-14DP
104208412034-03-14U-1672, U-2631, U-3360, U-3361
112786222034-03-14U-3335, U-3336
84764252032-09-27DP
86859572032-09-27DPU-36
97243532032-09-07U-2565, U-2566
100289632032-09-07U-2565, U-2566
71292322028-05-15DS, DPU-36, U-1676, U-3360, U-3361
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01D: Other beta-lactam antibacterials in atc
— J01DI: Other cephalosporins and penems in atc
— J01DI54: Ceftolozane and beta-lactamase inhibitor
HCPCS
Code
Description
J0695
Injection, ceftolozane 50 mg and tazobactam 25 mg
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337——11—1—2
NeutropeniaD009503—D70———2—2
Febrile neutropeniaD064147—————2—2
BurnsD002056—T30.0———1—1
PharmacokineticsD010599—————1—1
FeverD005334HP_0001945R50.9———1—1
HyperthermiaD000084462—————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—133——7
Communicable diseasesD003141———33——6
Intraabdominal infectionsD059413———12——3
BacteremiaD016470EFO_0003033R78.81111——2
Urinary tract infectionsD014552EFO_0003103N39.0—11——2
PyelonephritisD011704EFO_1001141N10-N16—11——2
SepsisD018805HP_0100806A41.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8011——12
PneumoniaD011014EFO_0003106—21———2
Pseudomonas infectionsD011552EFO_0001076A41.5211———1
Pseudomonas aeruginosaD011550NCBITaxon_287—11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthcare-associated pneumoniaD000077299——1————1
Diabetes mellitusD003920HP_0000819E08-E131————1
Wound infectionD014946——1————1
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCeftolozane
INNceftolozane
Description
Ceftolozane is a fifth-generation cephalosporin antibiotic having (5-amino-4-{[(2-aminoethyl)carbamoyl]amino}-1-methyl-1H-pyrazol-2-ium-2-yl)methyl and [(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino side groups located at positions 3 and 7 respectively; developed for the treatment of infections with gram-negative bacteria that have become resistant to conventional antibiotics. It is a cephalosporin and a member of thiadiazoles.
Classification
Small molecule
Drug classcephalosporins
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Structure (InChI/SMILES or Protein Sequence)
Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)/C(=N\OC(C)(C)C(=O)[O-])c3nsc(N)n3)[C@H]2SC1
Identifiers
PDB—
CAS-ID689293-68-3
RxCUI—
ChEMBL IDCHEMBL2103872
ChEBI ID—
PubChem CID53234134
DrugBank—
UNII ID37A4IES95Q (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zerbaxa – Merck & Co
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,286 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,015 adverse events reported
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