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

Stem definitionDrug idCAS RN
calcitonin gene-related peptide receptor antagonists 5361 1374248-77-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ubrogepant
  • ubrelvy
Ubrogepant is a calcitonin gene-related peptide receptor antagonist.
  • Molecular weight: 549.55
  • Formula: C29H26F3N5O3
  • CLOGP: -4.62
  • LIPINSKI: 1
  • HAC: 8
  • HDO: 2
  • TPSA: 104.29
  • ALOGS: 2.93
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 2019 FDA ALLERGAN

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
Migraine 46.63 44.09 17 265 80400 53268384

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

Pharmacologic Action:

SourceCodeDescription
ATC N02CD04 NERVOUS SYSTEM
ANALGESICS
ANTIMIGRAINE PREPARATIONS
Calcitonin gene-related peptide (CGRP) antagonists

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Migraine indication 37796009 DOID:6364

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.67 acidic
pKa2 11.49 acidic
pKa3 2.79 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 9499545 Nov. 10, 2031 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
100MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 9833448 Nov. 10, 2031 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
50MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 9499545 Nov. 10, 2031 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
50MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 9833448 Nov. 10, 2031 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
100MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 8754096 July 19, 2032 ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS
50MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL 8754096 July 19, 2032 ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL Dec. 23, 2024 NEW CHEMICAL ENTITY
50MG UBRELVY ALLERGAN N211765 Dec. 23, 2019 RX TABLET ORAL Dec. 23, 2024 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Calcitonin gene-related peptide type 1 receptor GPCR ANTAGONIST Ki 10.20 IUPHAR DRUG LABEL

External reference:

IDSource
4039081 VANDF
CHEMBL2364638 ChEMBL_ID
D10673 KEGG_DRUG
C000615620 MESH_SUPPLEMENTAL_RECORD_UI
10176 IUPHAR_LIGAND_ID
9803 INN_ID
DB15328 DRUGBANK_ID
AD0O8X2QJR UNII
68748835 PUBCHEM_CID
2268216 RXNORM
838467004 SNOMEDCT_US
838488008 SNOMEDCT_US
328458 MMSL
37856 MMSL
d09467 MMSL
018241 NDDF
C4505936 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
UBRELVY HUMAN PRESCRIPTION DRUG LABEL 1 0023-6498 TABLET 50 mg ORAL NDA 29 sections
UBRELVY HUMAN PRESCRIPTION DRUG LABEL 1 0023-6501 TABLET 100 mg ORAL NDA 29 sections