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Drug ReportsAvibactam
Avycaz, Zavicefta(avibactam)
Avycaz, 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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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3M
6M
YTD
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start 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
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
AVYCAZAllerganN-206494 RX2015-02-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
avycazNew Drug Application2024-01-26
Agency Specific
FDA
EMA
Expiration
Code
AVIBACTAM SODIUM / CEFTAZIDIME, AVYCAZ, ALLERGAN
2025-12-20NPP
2025-02-25GAIN
2020-02-25NCE
Patent Expiration
Patent
Expires
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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
60 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intraabdominal infectionsD059413———351110
Urinary tract infectionsD014552EFO_0003103N39.0—331—7
Healthcare-associated pneumoniaD000077299——1—2216
InfectionsD007239EFO_0000544—2—1126
Ventilator-associated pneumoniaD053717EFO_1001865J95.851——2114
Gram-negative bacterial infectionsD016905———2—1—3
Cystic fibrosisD003550EFO_0000390E84———1—1
BacteremiaD016470EFO_0003033R78.81———1—1
PyelonephritisD011704EFO_1001141N10-N16———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424—A49211—36
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C80—1———1
Febrile neutropeniaD064147———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———7————7
Renal insufficiencyD051437HP_0000083N191———12
PharmacokineticsD010599——2————2
PneumoniaD011014EFO_0003106—1———12
Systemic inflammatory response syndromeD018746EFO_1001478R65.101————1
Aids-related complexD000386EFO_0007137B201————1
PeritonitisD010538EFO_0008588K651————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B49————11
Critical illnessD016638——————11
Respiratory distress syndromeD012128EFO_1000637J80————11
Cross infectionD003428——————11
SepsisD018805HP_0100806A41.9————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
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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 6,146 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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773 adverse events reported
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