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avibactam 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| beta-lactamase inhibitors | 4946 | 1192500-31-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a non-beta-lactam beta-lactamase inhibitor that inactivates some beta-lactamases and protects ceftazidime from degradation by certain beta-lactamases
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 0.24 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 2.76 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.93 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1.70 hours | Lombardo F, Berellini G, Obach RS |
| S (Water solubility) | 10 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | -2.898 | Moderate | 0.68 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.933 | Moderate | 0.68 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 0.202 | 10^-6 cm/s | Moderate | 0.68 |
| dh-clint | Dog hepatocyte intrinsic clearance | 2.754 | uL/min/10^6 cells | Moderate | 0.68 |
| dppb | Dog plasma protein binding (% unbound) | 77.010 | % | Moderate | 0.68 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 69.710 | % | Moderate | 0.68 |
| herg | hERG pIC50 | 4.007 | pIC50 | Moderate | 0.68 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.050 | uL/min/10^6 cells | Moderate | 0.68 |
| hlm-clint | Human liver microsomal intrinsic clearance | 4.315 | uL/min/mg protein | Moderate | 0.68 |
| hppb | Human plasma protein binding (% unbound) | 75.810 | % | Moderate | 0.68 |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 0.238 | Moderate | 0.68 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 1.600 | Moderate | 0.68 | |
| mppb | Mouse plasma protein binding (% unbound) | 82.050 | Moderate | 0.68 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 0.356 | Moderate | 0.68 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 74.560 | % | Moderate | 0.68 |
| rh-clint | Rat hepatocyte intrinsic clearance | 1.652 | uL/min/10^6 cells | Moderate | 0.68 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 95.970 | % | Moderate | 0.68 |
| rppb | Rat plasma protein binding (% unbound) | 75.590 | % | Moderate | 0.68 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 926.830 | uM | Moderate | 0.68 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Feb. 25, 2015 | FDA | CEREXA INC |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug resistance | 59.13 | 56.17 | 18 | 484 | 56356 | 110532441 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000000202 | beta Lactamase Inhibitors |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000900 | Anti-Bacterial Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D065093 | beta-Lactamase Inhibitors |
| FDA EPC | N0000175930 | beta Lactamase Inhibitor |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:35625 | EC 3.5.2.6 (β-lactamase) inhibitor |
| CHEBI has role | CHEBI:36047 | antibacterial drug |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pyelonephritis | indication | 45816000 | DOID:11400 |
| Infectious disease of abdomen | indication | 128070006 | |
| Bacterial urinary infection | indication | 312124009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.64 | acidic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 0.5GM BASE;2GM/VIAL | AVYCAZ | ABBVIE | N206494 | Feb. 25, 2015 | RX | POWDER | INTRAVENOUS | 7112592 | Jan. 7, 2026 | A METHOD OF TREATING BACTERIAL INFECTIONS IN COMPLICATED INTRA-ABDOMINAL INFECTION AND COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS, PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM |
| EQ 0.5GM BASE;2GM/VIAL | AVYCAZ | ABBVIE | N206494 | Feb. 25, 2015 | RX | POWDER | INTRAVENOUS | 7112592 | Jan. 7, 2026 | A METHOD OF TREATING BACTERIAL INFECTIONS IN HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM |
| EQ 0.5GM BASE;2GM/VIAL | AVYCAZ | ABBVIE | N206494 | Feb. 25, 2015 | RX | POWDER | INTRAVENOUS | 7112592 | Jan. 7, 2026 | METHOD OF TREATING BACTERIAL INFECTIONS |
| EQ 0.5GM BASE;2GM/VIAL | AVYCAZ | ABBVIE | N206494 | Feb. 25, 2015 | RX | POWDER | INTRAVENOUS | 7112592 | Jan. 7, 2026 | TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS, COMPLICATED URINARY TRACT INFECTIONS, AND HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN ADULT AND PEDIATRIC PATIENTS (AT LEAST 31 WEEKS GESTATIONAL AGE) |
| EQ 0.5GM BASE/VIAL;1.5GM/VIAL | EMBLAVEO | ABBVIE | N217906 | Feb. 7, 2025 | RX | POWDER | INTRAVENOUS | 7112592 | Jan. 7, 2026 | TREATMENT OF COMPLICATED INTRA-ABDOMINAL BACTERIAL INFECTIONS IN ADULT PATIENTS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 0.5GM BASE;2GM/VIAL | AVYCAZ | ABBVIE | N206494 | Feb. 25, 2015 | RX | POWDER | INTRAVENOUS | Jan. 26, 2027 | NEW PATIENT POPULATION |
| EQ 0.5GM BASE/VIAL;1.5GM/VIAL | EMBLAVEO | ABBVIE | N217906 | Feb. 7, 2025 | RX | POWDER | INTRAVENOUS | Feb. 7, 2028 | NEW PRODUCT |
| EQ 0.5GM BASE/VIAL;1.5GM/VIAL | EMBLAVEO | ABBVIE | N217906 | Feb. 7, 2025 | RX | POWDER | INTRAVENOUS | Feb. 7, 2033 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Beta-lactamase | Enzyme | INHIBITOR | Kd | 8.16 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Beta-lactamase | Enzyme | INHIBITOR | Kd | 6.18 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Beta-lactamase | Enzyme | INHIBITOR | Kd | 8.70 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Penicillin-binding protein 2 | Enzyme | IC50 | 6.23 | CHEMBL | |||||
| Beta-lactamase TEM | Enzyme | IC50 | 8.72 | CHEMBL | |||||
| Beta-lactamase | Enzyme | Ki | 5.77 | CHEMBL | |||||
| Beta-lactamase | Enzyme | Ki | 7.96 | CHEMBL | |||||
| Beta-lactamase OXA-1 | Enzyme | IC50 | 6.89 | CHEMBL | |||||
| Carbepenem-hydrolyzing beta-lactamase KPC | Enzyme | IC50 | 6.73 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 7352665165 | UNII |
| D10340 | KEGG_DRUG |
| 4034342 | VUID |
| N0000191549 | NUI |
| 396731-20-7 | SECONDARY_CAS_RN |
| 1192491-61-4 | SECONDARY_CAS_RN |
| 4034342 | VANDF |
| C3489748 | UMLSCUI |
| FYG | PDB_CHEM_ID |
| CHEMBL1689063 | ChEMBL_ID |
| 9835049 | PUBCHEM_CID |
| DB09060 | DRUGBANK_ID |
| CHEMBL2107817 | ChEMBL_ID |
| 8972 | INN_ID |
| C543519 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10761 | IUPHAR_LIGAND_ID |
| C492231 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1603833 | RXNORM |
| 30974 | MMSL |
| d08357 | MMSL |
| 015925 | NDDF |
| 015926 | NDDF |
| 1193767002 | SNOMEDCT_US |
| 715180004 | SNOMEDCT_US |
| CHEBI:85982 | CHEBI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| EMBLAVEO | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0074-3878 | POWDER, FOR SOLUTION | 42.30 mg | INTRAVENOUS | NDA | 28 sections |
| AVYCAZ | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0456-2700 | POWDER, FOR SOLUTION | 0.50 g | INTRAVENOUS | NDA | 30 sections |