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

Stem definitionDrug idCAS RN
antibiotics, protein-synthesis inhibitors, tetracycline derivatives 5294 1334714-66-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • eravacycline dihydrochloride
  • xerava
  • TP-434
Eravacycline is a fluorocycline antibacterial within the tetracycline class of antibacterial drugs. Eravacycline disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.
  • Molecular weight: 558.56
  • Formula: C27H31FN4O8
  • CLOGP: 0.01
  • LIPINSKI: 3
  • HAC: 12
  • HDO: 6
  • TPSA: 193.73
  • ALOGS: -2.82
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 2.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.71 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.18 % Lombardo F, Berellini G, Obach RS
S (Water solubility) 50 mg/mL Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2018 EMA TETRAPHASE PHARMS
Aug. 27, 2018 FDA TETRAPHASE PHARMS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

None

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

DiseaseRelationSNOMED_IDDOID
Infectious disease of abdomen indication 128070006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.13 acidic
pKa2 8.11 acidic
pKa3 10.06 acidic
pKa4 11.96 acidic
pKa5 12.87 acidic
pKa6 13.5 acidic
pKa7 9.56 Basic
pKa8 8.88 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 100MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 June 3, 2020 RX POWDER INTRAVENOUS 8796245 Aug. 7, 2029 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN PATIENTS 18 YEARS OF AGE AND OLDER
EQ 50MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 Aug. 27, 2018 RX POWDER INTRAVENOUS 8796245 Aug. 7, 2029 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS IN PATIENTS 18 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 100MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 June 3, 2020 RX POWDER INTRAVENOUS Aug. 27, 2023 NEW CHEMICAL ENTITY
EQ 50MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 Aug. 27, 2018 RX POWDER INTRAVENOUS Aug. 27, 2023 NEW CHEMICAL ENTITY
EQ 100MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 June 3, 2020 RX POWDER INTRAVENOUS Aug. 27, 2028 GENERATING ANTIBIOTIC INCENTIVES NOW
EQ 50MG BASE/VIAL XERAVA TETRAPHASE PHARMS N211109 Aug. 27, 2018 RX POWDER INTRAVENOUS Aug. 27, 2028 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

None

External reference:

IDSource
WK1NMH89VJ UNII
C4723361 UMLSCUI
CHEMBL2219414 ChEMBL_ID
56951485 PUBCHEM_CID
CHEMBL1951095 ChEMBL_ID
D10369 KEGG_DRUG
288715 MMSL
34818 MMSL
017696 NDDF
DB12329 DRUGBANK_ID
2055907 RXNORM
C571179 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xerava HUMAN PRESCRIPTION DRUG LABEL 1 71773-050 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 50 mg INTRAVENOUS NDA 30 sections
Xerava HUMAN PRESCRIPTION DRUG LABEL 1 71773-100 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 30 sections