oritavancin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4678 171099-57-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • oritavancin diphosphate
  • orbactiv
  • LY333328
  • oritavancin
  • Molecular weight: 1793.12
  • Formula: C86H97Cl3N10O26
  • CLOGP: 2.50
  • LIPINSKI: 3
  • HAC: 36
  • HDO: 20
  • TPSA: 560.98
  • ALOGS: -4.48
  • ROTB: 19

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.07 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.13 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 96.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 19, 2015 EMA
Aug. 6, 2014 FDA THE MEDICINES CO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pruritus 181.71 63.41 81 546 283487 50321010
Urticaria 94.73 63.41 41 586 129520 50474977
Off label use 82.90 63.41 58 569 474368 50130129

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Off label use 106.28 68.74 70 568 300730 29273159
Chills 76.80 68.74 35 603 71265 29502624
Back pain 73.39 68.74 38 600 102246 29471643

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pruritus 155.61 72.23 83 983 312317 64185349
Off label use 142.49 72.23 101 965 632705 63864961
Urticaria 120.22 72.23 55 1011 147262 64350404
Chills 95.62 72.23 46 1020 137218 64360448
Infusion related reaction 73.67 72.23 41 1025 164426 64333240
Back pain 72.26 72.23 47 1019 250124 64247542

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01XA05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER ANTIBACTERIALS
Glycopeptide antibacterials
FDA CS M000640741 Lipoglycopeptides
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000185504 Cytochrome P450 2C9 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
FDA MoA N0000191267 Cytochrome P450 2D6 Inducers
FDA EPC N0000191281 Lipoglycopeptide Antibacterial
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:36047 antibacterial drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Bacterial infection of skin indication 128936008
Streptococcal infection of skin indication 402937004
Staphylococcal infection of skin indication 402938009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.05 acidic
pKa2 7.69 acidic
pKa3 10.72 acidic
pKa4 11.48 acidic
pKa5 11.49 acidic
pKa6 12.17 acidic
pKa7 12.41 acidic
pKa8 13.03 acidic
pKa9 13.04 acidic
pKa10 13.67 acidic
pKa11 9.27 Basic
pKa12 8.57 Basic
pKa13 8.3 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS 8420592 Aug. 29, 2029 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS 8420592 Aug. 29, 2029 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS 9682061 April 26, 2030 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS 9682061 April 26, 2030 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS Aug. 6, 2019 NEW CHEMICAL ENTITY
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS Aug. 6, 2019 NEW CHEMICAL ENTITY
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS March 12, 2024 NEW PRODUCT
EQ 400MG BASE/VIAL ORBACTIV MELINTA THERAP N206334 Aug. 6, 2014 RX POWDER INTRAVENOUS Aug. 6, 2024 GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 1.2GM BASE/VIAL KIMYRSA MELINTA THERAP N214155 March 12, 2021 RX POWDER INTRAVENOUS Aug. 6, 2024 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

None

External reference:

IDSource
D05271 KEGG_DRUG
4033672 VUID
N0000191086 NUI
192564-14-0 SECONDARY_CAS_RN
4033671 VANDF
4033672 VANDF
CHEBI:83305 CHEBI
CHEMBL1688530 ChEMBL_ID
CHEMBL3989766 ChEMBL_ID
C100708 MESH_SUPPLEMENTAL_RECORD_UI
10877 IUPHAR_LIGAND_ID
7979 INN_ID
DB04911 DRUGBANK_ID
PUG62FRZ2E UNII
16136912 PUBCHEM_CID
1547611 RXNORM
227540 MMSL
30470 MMSL
39633 MMSL
d08276 MMSL
015538 NDDF
015661 NDDF
704655001 SNOMEDCT_US
704656000 SNOMEDCT_US
C1144403 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Orbactiv HUMAN PRESCRIPTION DRUG LABEL 1 70842-140 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS NDA 32 sections
Orbactiv HUMAN PRESCRIPTION DRUG LABEL 1 70842-140 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 400 mg INTRAVENOUS NDA 32 sections
Kimyrsa HUMAN PRESCRIPTION DRUG LABEL 1 70842-225 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1200 mg INTRAVENOUS NDA 31 sections