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

Stem definitionDrug idCAS RN
antibacterials, nalidixic acid derivatives 4920 209342-40-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • finafloxacin
  • xtoro
  • finafloxacin hydrochloride
  • BAY35-3377
  • finafloxacin HCl
Finafloxacin belongs to the fluoroquinolone class of antibacterials which involves the inhibition of bacterial type II topoisomerase enzymes, DNA gyrase and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination.
  • Molecular weight: 398.39
  • Formula: C20H19FN4O4
  • CLOGP: -1.56
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 105.90
  • ALOGS: -3.28
  • ROTB: 3

  • Status: OFM

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.42 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.75 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.75 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 13.42 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 17, 2014 FDA ALCON RES LTD

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
FDA CS M0023650 Quinolones
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000892 Anti-Infective Agents, Urinary
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D059005 Topoisomerase II Inhibitors
FDA EPC N0000175937 Quinolone Antimicrobial
CHEBI has role CHEBI:33281 antibiotics
CHEBI has role CHEBI:36047 antibacterial drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute otitis externa indication 30250000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.68 acidic
pKa2 6.18 Basic
pKa3 2.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.3% XTORO MERLION PHARMS GMBH N206307 Dec. 17, 2014 DISCN SUSPENSION/DROPS OTIC 9119859 July 2, 2030 TREATMENT OF ACUTE OTITIS EXTERNA
0.3% XTORO MERLION PHARMS GMBH N206307 Dec. 17, 2014 DISCN SUSPENSION/DROPS OTIC 8536167 Aug. 8, 2031 TREATMENT OF ACUTE OTITIS EXTERNA
0.3% XTORO MERLION PHARMS GMBH N206307 Dec. 17, 2014 DISCN SUSPENSION/DROPS OTIC 9504691 Nov. 21, 2033 TREATMENT OF ACUTE OTITIS EXTERNA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D26OSN9Q4R UNII
D10575 KEGG_DRUG
209342-41-6 SECONDARY_CAS_RN
C2825286 UMLSCUI
CHEBI:85176 CHEBI
CHEMBL1908370 ChEMBL_ID
11567473 PUBCHEM_CID
DB09047 DRUGBANK_ID
C560572 MESH_SUPPLEMENTAL_RECORD_UI
10809 IUPHAR_LIGAND_ID
8121 INN_ID
1598641 RXNORM
708794002 SNOMEDCT_US
714690003 SNOMEDCT_US

Pharmaceutical products:

None