uridine triacetate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
uridine derivatives used as antiviral agents and as antineoplastics 5029 4105-38-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • uridine triacetate
  • PN401
  • xuriden
  • vistogard
Uridine triacetate is an acetylated form of uridine. Following oral administration, uridine triacetate is deacetylated by nonspecific esterases present throughout the body, yielding uridine in the systemic circulation of patients with hereditary orotic aciduria who cannot synthesize adequate quantities of uridine due to a genetic defect in uridine nucleotide synthesis.
  • Molecular weight: 356.29
  • Formula: C14H16N2O9
  • CLOGP: -0.59
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 1
  • TPSA: 137.54
  • ALOGS: -1.26
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 4, 2015 FDA WELLSTAT THERAPEUTICS CORP

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC A16AX13 ALIMENTARY TRACT AND METABOLISM
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
Various alimentary tract and metabolism products
FDA Chemical/Ingredient N0000007587 Pyrimidines
FDA Chemical/Ingredient N0000175452 Analogs/Derivatives
FDA EPC N0000191809 Pyrimidine Analog
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:77746 H. sapiens metabolites
CHEBI has role CHEBI:78675 essential metabolite
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:71031 orphan drugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hereditary orotic aciduria indication 16242007
Antimetabolite overdose indication 295696001

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.68 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL 7776838 Aug. 17, 2027 EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2GM/PACKET XURIDEN WELLSTAT THERAP N208169 Sept. 4, 2015 RX GRANULE ORAL Sept. 4, 2022 TREATMENT OF HEREDITARY OROTIC ACIDURIA
10GM/PACKET VISTOGARD WELLSTAT THERAP N208159 Dec. 11, 2015 RX GRANULE ORAL Dec. 11, 2022 EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN.

Bioactivity Summary:

None

External reference:

IDSource
2WP61F175M UNII
58-96-8 SECONDARY_CAS_RN
4035398 VANDF
4035399 VANDF
C0281351 UMLSCUI
CHEBI:90914 CHEBI
CHEBI:16704 CHEBI
URI PDB_CHEM_ID
CHEMBL2107381 ChEMBL_ID
20058 PUBCHEM_CID
DB09144 DRUGBANK_ID
C000609666 MESH_SUPPLEMENTAL_RECORD_UI
4566 IUPHAR_LIGAND_ID
6029 PUBCHEM_CID
DB02745 DRUGBANK_ID
WHI7HQ7H85 UNII
9204 INN_ID
11017 RXNORM
237553 MMSL
238118 MMSL
31371 MMSL
d05935 MMSL
005776 NDDF
016442 NDDF
57763003 SNOMEDCT_US
715619008 SNOMEDCT_US
D014529 MESH_DESCRIPTOR_UI
C0041984 UMLSCUI
CHEMBL100259 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VISTOGARD HUMAN PRESCRIPTION DRUG LABEL 1 69468-151 GRANULE 951 mg ORAL NDA 25 sections
XURIDEN HUMAN PRESCRIPTION DRUG LABEL 1 69468-152 GRANULE 951 mg ORAL NDA 26 sections