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Drug ReportsAvibactam
Avycaz, Zavicefta(avibactam)
Avycaz, Emblaveo, Zavicefta (avibactam) is a small molecule pharmaceutical. Avibactam was first approved as Avycaz on 2015-02-25. It is used to treat escherichia coli infections, intraabdominal infections, klebsiella infections, proteus infections, and pseudomonas infections in the USA. It has been approved in Europe to treat bacterial pneumonia, gram-negative bacterial infections, pneumonia, soft tissue infections, and urinary tract infections.
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Commercial
Clinical
Drug
Target
Variants
Financial
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Safety
Events Timeline
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YTD
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2Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
urogenital diseasesD000091642
Trade Name
FDA
EMA
Combinations
Avycaz, Emblaveo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Avibactam sodium
+
Ceftazidime
Tradename
Company
Number
Date
Products
AVYCAZAbbVieN-206494 RX2015-02-25
1 products, RLD, RS
Avibactam sodium
+
Aztreonam
Tradename
Company
Number
Date
Products
EMBLAVEOAbbVieN-217906 RX2025-02-07
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
avycazNew Drug Application2025-04-25
emblaveoNew Drug Application2025-02-07
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sepsisEFO_0001420D018805A41.9
neutropenia—D009503D70
fever—D005334R50.9
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
intraabdominal infections—D059413—
pseudomonas infectionsEFO_0001076D011552A41.52
bacterial skin diseases—D017192—
escherichia coli infectionsEFO_1001318D004927B96.20
soft tissue infections—D018461—
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Agency Specific
FDA
EMA
Expiration
Code
AVIBACTAM SODIUM / CEFTAZIDIME, AVYCAZ, ALLERGAN
2025-12-20NPP
2025-02-25GAIN
2020-02-25NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Avibactam Sodium / Ceftazidime, Avycaz, Allergan
89695662032-06-15DP
92843142032-06-15DP
96951222032-06-15DP
84710252031-08-12DP
88354552030-10-08DP
76120872026-11-12DP
71125922026-01-07DS, DPU-282, U-2244, U-2508, U-3818
ATC Codes
No data
HCPCS
Code
Description
J0714
Injection, ceftazidime and avibactam, 0.5 g/0.125 g
Clinical
Clinical Trials
84 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—2462317
Communicable diseasesD003141——1262314
Intraabdominal infectionsD059413——1351212
Healthcare-associated pneumoniaD000077299——1—2328
Urinary tract infectionsD014552EFO_0003103N39.0123118
PneumoniaD011014EFO_0003106J181—2216
Ventilator-associated pneumoniaD053717EFO_1001865J95.851——2215
SepsisD018805EFO_0001420A41.91——113
Cross infectionD003428—————112
BacteremiaD016470EFO_0003033R78.81———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424—A49111——3
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gram-negative bacterial infectionsD016905———3——14
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———8————8
Renal insufficiencyD051437—N191———12
PharmacokineticsD010599——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory distress syndromeD012128EFO_1000637J80————11
Acute lung injuryD055371EFO_0004610—————11
Newborn respiratory distress syndromeD012127—P22————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAvibactam
INNavibactam
Description
Avibactam is a member of the class of azabicycloalkanes that is (2S,5R)-7-oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide in which the amino hydrogen at position 6 is replaced by a sulfooxy group. Used (in the form of its sodium salt) in combination with ceftazidime pentahydrate for the treatment of complicated urinary tract infections including pyelonephritis. It has a role as an antibacterial drug, an antimicrobial agent and an EC 3.5.2.6 (beta-lactamase) inhibitor. It is a monocarboxylic acid amide, a member of ureas, an azabicycloalkane and a hydroxylamine O-sulfonic acid. It is a conjugate acid of an avibactam(1-).
Classification
Small molecule
Drug classbeta-lactamase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NC(=O)[C@@H]1CC[C@@H]2CN1C(=O)N2OS(=O)(=O)O
Identifiers
PDB—
CAS-ID1192500-31-4
RxCUI—
ChEMBL IDCHEMBL1689063
ChEBI ID85984
PubChem CID9835049
DrugBank—
UNII ID7352665165 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Zavicefta – Pfizer
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Avycaz – Allergan
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Avycaz – Warner Chilcott
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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 9,509 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,949 adverse events reported
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