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

Stem definition	Drug id	CAS RN
calcitonin gene-related peptide receptor antagonists	5361	1374248-77-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ubrogepant ubrelvy	Ubrogepant is a calcitonin gene-related peptide receptor antagonist. Molecular weight: 549.55 Formula: C29H26F3N5O3 CLOGP: 3.12 LIPINSKI: 1 HAC: 8 HDO: 2 TPSA: 104.29 ALOGS: -4.62 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ubrogepant
ubrelvy

Ubrogepant is a calcitonin gene-related peptide receptor antagonist.

Molecular weight: 549.55
Formula: C29H26F3N5O3
CLOGP: 3.12
LIPINSKI: 1
HAC: 8
HDO: 2
TPSA: 104.29
ALOGS: -4.62
ROTB: 5

Status: ONP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Dec. 23, 2019	FDA	ALLERGAN

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Migraine	66.88	28.22	34	1117	103312	63384559
COVID-19	50.20	28.22	29	1122	113074	63374797
Drug ineffective	36.32	28.22	66	1085	1044699	62443172

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FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Migraine	60.76	32.73	25	750	87468	79656145
COVID-19	35.75	32.73	21	754	157653	79585960

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02CD04	NERVOUS SYSTEM ANALGESICS ANTIMIGRAINE PREPARATIONS Calcitonin gene-related peptide (CGRP) antagonists
FDA EPC	N0000193917	Calcitonin Gene-related Peptide Receptor Antagonist
FDA MoA	N0000193918	Calcitonin Gene-related Peptide Receptor Antagonists

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

Disease	Relation	SNOMED_ID	DOID
Migraine	indication	37796009	DOID:6364

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.67	acidic
pKa2	11.49	acidic
pKa3	2.79	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	9499545	Nov. 10, 2031	ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
100MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	9833448	Nov. 10, 2031	ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
100MG	UBRELVY	ABBVIE	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	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	9499545	Nov. 10, 2031	ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
50MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	9833448	Nov. 10, 2031	ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
50MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	8754096	July 19, 2032	ACUTE TREATMENT OF MIGRAINE WITH HEADACHE, WITH OR WITHOUT AURA IN ADULTS

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	Dec. 23, 2024	NEW CHEMICAL ENTITY
50MG	UBRELVY	ABBVIE	N211765	Dec. 23, 2019	RX	TABLET	ORAL	Dec. 23, 2024	NEW CHEMICAL ENTITY

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Calcitonin gene-related peptide type 1 receptor	GPCR	Q16602	CALRL_HUMAN	ANTAGONIST	Ki	10.20		IUPHAR	DRUG LABEL

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External reference:

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ID	Source
018241	NDDF
10176	IUPHAR_LIGAND_ID
2268216	RXNORM
328458	MMSL
37856	MMSL
4039081	VANDF
68748835	PUBCHEM_CID
838467004	SNOMEDCT_US
838488008	SNOMEDCT_US
9803	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
UBRELVY	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6498	TABLET	50 mg	ORAL	NDA	32 sections
UBRELVY	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6498	TABLET	50 mg	ORAL	NDA	32 sections
UBRELVY	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6501	TABLET	100 mg	ORAL	NDA	32 sections
UBRELVY	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6501	TABLET	100 mg	ORAL	NDA	32 sections

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