dalbavancin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
777 171500-79-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • xydalba
  • dalvance
  • dalbavancin
  • dalbavancin hydrochloride
  • BI397
  • MDL 63,397
  • VER001
  • dalbavancin HCl
Dalbavancin, a semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking. Dalbavancin is bactericidal in vitro against Staphylococcus aureus and Streptococcus pyogenes at concentrations similar to those sustained throughout treatment in humans treated according to the recommended dosage regimen.
  • Molecular weight: 1816.71
  • Formula: C88H100Cl2N10O28
  • CLOGP: 5.64
  • LIPINSKI: 4
  • HAC: 38
  • HDO: 21
  • TPSA: 572.51
  • ALOGS: -4.05
  • ROTB: 22

Drug dosage:

DoseUnitRoute
1.50 g P

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.14 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.01 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 170 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 18, 2014 EMA
May 23, 2014 FDA DURATA THERAPS INTL

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01XA04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Glycopeptide antibacterials
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
FDA EXT N0000191280 Lipoglycopeptides
FDA EPC N0000191281 Lipoglycopeptide Antibacterial
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:36047 antibacterial drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Infection of skin AND/OR subcutaneous tissue indication 19824006
Bacterial infection of skin indication 128936008
Staphylococcal infection of skin indication 402938009

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.53 acidic
pKa2 7.41 acidic
pKa3 8.05 acidic
pKa4 8.37 acidic
pKa5 8.65 acidic
pKa6 9.93 acidic
pKa7 11.23 acidic
pKa8 11.94 acidic
pKa9 11.99 acidic
pKa10 12.61 acidic
pKa11 12.91 acidic
pKa12 13.23 acidic
pKa13 13.59 acidic
pKa14 13.73 acidic
pKa15 9.21 Basic
pKa16 6.62 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 500MG BASE/VIAL DALVANCE ALLERGAN N021883 May 23, 2014 RX POWDER INTRAVENOUS 8143212 Nov. 14, 2023 TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
EQ 500MG BASE/VIAL DALVANCE ALLERGAN N021883 May 23, 2014 RX POWDER INTRAVENOUS 6900175 Dec. 25, 2023 TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 500MG BASE/VIAL DALVANCE ALLERGAN N021883 May 23, 2014 RX POWDER INTRAVENOUS May 23, 2019 NEW CHEMICAL ENTITY
EQ 500MG BASE/VIAL DALVANCE ALLERGAN N021883 May 23, 2014 RX POWDER INTRAVENOUS May 23, 2024 GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 500MG BASE/VIAL DALVANCE ALLERGAN N021883 May 23, 2014 RX POWDER INTRAVENOUS July 22, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

None

External reference:

IDSource
D03640 KEGG_DRUG
C1172636 UMLSCUI
CHEBI:82721 CHEBI
CHEMBL3301669 ChEMBL_ID
CHEMBL3301650 ChEMBL_ID
DB06219 DRUGBANK_ID
C469289 MESH_SUPPLEMENTAL_RECORD_UI
10876 IUPHAR_LIGAND_ID
7978 INN_ID
808UI9MS5K UNII
16134627 PUBCHEM_CID
1539239 RXNORM
221316 MMSL
30328 MMSL
d08264 MMSL
015537 NDDF
015541 NDDF
703917001 SNOMEDCT_US
703918006 SNOMEDCT_US
703919003 SNOMEDCT_US
4025243 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DALVANCE HUMAN PRESCRIPTION DRUG LABEL 1 57970-100 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS NDA 28 sections