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

Stem definitionDrug idCAS RN
antibacterials, nalidixic acid derivatives 5238 189279-58-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • delafloxacin
  • delafloxacin meglumine
  • baxdela
  • RX-3341
  • WQ-3034
  • ABT-492
Delafloxacin belongs to the fluoroquinolone class of antibacterial drugs and is anionic in nature. The antibacterial activity of delafloxacin is due to the inhibition of both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes which are required for bacterial DNA replication, transcription, repair, and recombination. Delafloxacin exhibits a concentration-dependent bactericidal activity against gram-positive and gram-negative bacteria in vitro.
  • Molecular weight: 440.76
  • Formula: C18H12ClF3N4O4
  • CLOGP: 1.45
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 119.99
  • ALOGS: -3.80
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.90 g O
0.60 g P

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.35 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.33 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.16 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.10 hours Lombardo F, Berellini G, Obach RS
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Dec. 16, 2019 EMA A. Menarini Industrie Farmaceutiche Riunite s.r.l.
June 19, 2017 FDA MELINTA THERAPEUTICS INC

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
Diarrhoea 67.81 63.01 23 29 715343 62773627

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01MA23 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
QUINOLONE ANTIBACTERIALS
Fluoroquinolones
FDA CS M0372253 Fluoroquinolones
MeSH PA D000890 Anti-Infective Agents
FDA EPC N0000193223 Fluoroquinolone Antibacterial

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

DiseaseRelationSNOMED_IDDOID
Bacterial infection of skin indication 128936008




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.78 acidic
pKa2 11.32 acidic
pKa3 1.05 Basic
pKa4 0.46 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL 8648093 Oct. 7, 2025 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL 8969569 Oct. 7, 2025 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL 9539250 Oct. 7, 2025 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 300MG BASE/VIAL BAXDELA MELINTA N208611 June 19, 2017 RX POWDER INTRAVENOUS 8648093 Oct. 7, 2025 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 300MG BASE/VIAL BAXDELA MELINTA N208611 June 19, 2017 RX POWDER INTRAVENOUS 9539250 Oct. 7, 2025 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL 8252813 Oct. 2, 2026 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
EQ 300MG BASE/VIAL BAXDELA MELINTA N208611 June 19, 2017 RX POWDER INTRAVENOUS 8252813 Oct. 2, 2026 TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL June 19, 2022 NEW CHEMICAL ENTITY
EQ 300MG BASE/VIAL BAXDELA MELINTA N208611 June 19, 2017 RX POWDER INTRAVENOUS June 19, 2022 NEW CHEMICAL ENTITY
EQ 450MG BASE BAXDELA MELINTA N208610 June 19, 2017 RX TABLET ORAL June 19, 2027 GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 300MG BASE/VIAL BAXDELA MELINTA N208611 June 19, 2017 RX POWDER INTRAVENOUS June 19, 2027 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

None

External reference:

IDSource
6315412YVF UNII
352458-37-8 SECONDARY_CAS_RN
4036880 VANDF
C2828290 UMLSCUI
CHEMBL2105637 ChEMBL_ID
487101 PUBCHEM_CID
DB11943 DRUGBANK_ID
D09330 KEGG_DRUG
CHEMBL2105638 ChEMBL_ID
9064 INN_ID
C405494 MESH_SUPPLEMENTAL_RECORD_UI
10799 IUPHAR_LIGAND_ID
258700 MMSL
32817 MMSL
d08601 MMSL
017249 NDDF
017250 NDDF
735011001 SNOMEDCT_US
735012008 SNOMEDCT_US
763596009 SNOMEDCT_US
1927662 RXNORM
C477891 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Baxdela HUMAN PRESCRIPTION DRUG LABEL 1 70842-101 TABLET 450 mg ORAL NDA 33 sections
Baxdela HUMAN PRESCRIPTION DRUG LABEL 1 70842-101 TABLET 450 mg ORAL NDA 33 sections
Baxdela HUMAN PRESCRIPTION DRUG LABEL 1 70842-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 mg INTRAVENOUS NDA 33 sections
Baxdela HUMAN PRESCRIPTION DRUG LABEL 1 70842-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 300 mg INTRAVENOUS NDA 33 sections