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

Stem definition	Drug id	CAS RN
amide type nootrope agents, piracetam derivatives	5068	357336-20-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: brivaracetam briviact UCB 34714 UCB-34714	Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. Molecular weight: 212.29 Formula: C11H20N2O2 CLOGP: 1.01 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 63.40 ALOGS: -0.66 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

brivaracetam
briviact
UCB 34714
UCB-34714

Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect.

Molecular weight: 212.29
Formula: C11H20N2O2
CLOGP: 1.01
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 63.40
ALOGS: -0.66
ROTB: 5

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O
0.10	g	P

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	0.56 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.75 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.83 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	8.98 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	700 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Jan. 14, 2016	EMA	UCB Pharma SA
Feb. 18, 2016	FDA	UCB INC

FDA Adverse Event Reporting System (Female)

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
Seizure	547.86	35.47	219	3148	132415	63353240
Generalised tonic-clonic seizure	180.46	35.47	65	3302	28951	63456704
Multiple-drug resistance	149.89	35.47	38	3329	5132	63480523
Off label use	128.72	35.47	167	3200	674295	62811360
Maternal exposure before pregnancy	117.35	35.47	34	3333	7569	63478086
Partial seizures	107.63	35.47	30	3337	5812	63479843
Status epilepticus	101.68	35.47	36	3331	15197	63470458
Irritability	98.34	35.47	43	3324	31651	63454004
Overdose	97.78	35.47	66	3301	115012	63370643
Suicidal ideation	86.67	35.47	49	3318	62372	63423283
Petit mal epilepsy	81.55	35.47	22	3345	3772	63481883
Maternal exposure during pregnancy	80.59	35.47	77	3290	219985	63265670
Behaviour disorder	80.42	35.47	21	3346	3178	63482477
Aggression	79.82	35.47	34	3333	23464	63462191
Anticonvulsant drug level increased	79.52	35.47	18	3349	1499	63484156
JC polyomavirus test	57.13	35.47	8	3359	36	63485619
Mood swings	54.11	35.47	24	3343	18224	63467431
Depression	47.21	35.47	55	3312	196437	63289218
Partial seizures with secondary generalisation	45.20	35.47	9	3358	404	63485251
Seizure cluster	36.96	35.47	7	3360	241	63485414
Aura	36.64	35.47	9	3358	1064	63484591
Focal dyscognitive seizures	36.06	35.47	11	3356	2910	63482745

FDA Adverse Event Reporting System (Male)

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
Seizure	489.41	45.70	211	2533	104646	34849541
Status epilepticus	143.60	45.70	49	2695	12565	34941622
Aggression	119.25	45.70	59	2685	38905	34915282
Generalised tonic-clonic seizure	118.88	45.70	49	2695	21125	34933062
Multiple-drug resistance	116.73	45.70	34	2710	5205	34948982
Off label use	108.28	45.70	147	2597	419377	34534810
Partial seizures	102.10	45.70	30	2714	4730	34949457
Drug ineffective	95.69	45.70	145	2599	456606	34497581
Irritability	77.26	45.70	38	2706	24652	34929535
Hyperammonaemic encephalopathy	74.20	45.70	20	2724	2304	34951883
Focal dyscognitive seizures	74.19	45.70	18	2726	1363	34952824
Drug level fluctuating	73.83	45.70	15	2729	500	34953687
Aura	73.66	45.70	14	2730	328	34953859
Overdose	73.18	45.70	59	2685	91000	34863187
Anger	58.25	45.70	25	2719	11859	34942328
Hydrocephalus	58.19	45.70	20	2724	5212	34948975
Psychogenic seizure	54.42	45.70	11	2733	357	34953830
Affective disorder	45.90	45.70	16	2728	4344	34949843

FDA Adverse Event Reporting System (Geriatric)

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
Seizure	640.77	38.64	274	4119	188560	79551435
Multiple-drug resistance	254.30	38.64	65	4328	8743	79731252
Generalised tonic-clonic seizure	199.49	38.64	79	4314	43831	79696164
Off label use	159.40	38.64	220	4173	906995	78833000
Status epilepticus	142.06	38.64	53	4340	24988	79715007
Partial seizures	136.39	38.64	40	4353	8938	79731057
Aggression	120.79	38.64	58	4335	50900	79689095
Irritability	116.62	38.64	53	4340	41091	79698904
Drug ineffective	110.45	38.64	205	4188	1080708	78659287
Behaviour disorder	104.17	38.64	30	4363	6283	79733712
Overdose	93.82	38.64	79	4314	184127	79555868
Suicidal ideation	83.24	38.64	52	4341	76288	79663707
Focal dyscognitive seizures	82.39	38.64	22	4371	3490	79736505
Maternal exposure before pregnancy	77.61	38.64	22	4371	4351	79735644
Partial seizures with secondary generalisation	75.84	38.64	15	4378	626	79739369
Hyperammonaemic encephalopathy	71.26	38.64	21	4372	4761	79735234
Anticonvulsant drug level increased	68.83	38.64	18	4375	2635	79737360
Petit mal epilepsy	67.53	38.64	21	4372	5706	79734289
Aura	64.44	38.64	14	4379	928	79739067
Anger	61.19	38.64	26	4367	17136	79722859
Mood swings	60.71	38.64	27	4366	19853	79720142
Epilepsy	57.97	38.64	33	4360	40827	79699168
JC polyomavirus test	56.47	38.64	8	4385	38	79739957
Hydrocephalus	54.70	38.64	20	4373	8880	79731115
Psychogenic seizure	54.45	38.64	14	4379	1917	79738078
Somnolence	53.88	38.64	66	4327	238915	79501080
Mental disorder	46.34	38.64	26	4367	31276	79708719
Abnormal behaviour	45.26	38.64	27	4366	36394	79703601
Seizure cluster	45.10	38.64	9	4384	393	79739602
Depression	42.70	38.64	56	4337	216734	79523261
Psychiatric symptom	40.25	38.64	15	4378	7020	79732975
Dizziness	40.21	38.64	89	4304	526352	79213643

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	N03AX23	NERVOUS SYSTEM ANTIEPILEPTICS ANTIEPILEPTICS Other antiepileptics
MeSH PA	D000927	Anticonvulsants
MeSH PA	D002491	Central Nervous System Agents
FDA MoA	N0000192345	Epoxide Hydrolase Inhibitors
CHEBI has role	CHEBI:35623	anticonvulsants

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

Disease	Relation	SNOMED_ID	DOID
Partial seizure	indication	29753000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.83	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
10MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
25MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
75MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER
50MG/5ML (10MG/ML)	BRIVIACT	UCB INC	N205837	May 12, 2016	RX	SOLUTION	INTRAVENOUS	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
50MG/5ML (10MG/ML)	BRIVIACT	UCB INC	N205837	May 12, 2016	RX	SOLUTION	INTRAVENOUS	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL ONSET SEIZURES IN PATIENTS WITH EPILEPSY AGED 16 YEARS AND OLDER WITH EPILEPSY
10MG/ML	BRIVIACT	UCB INC	N205838	May 12, 2016	RX	SOLUTION	ORAL	6911461	Feb. 21, 2026	TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS 4 YEARS OF AGE AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION
10MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION
25MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION
50MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION
75MG	BRIVIACT	UCB INC	N205836	May 12, 2016	RX	TABLET	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION
50MG/5ML (10MG/ML)	BRIVIACT	UCB INC	N205837	May 12, 2016	RX	SOLUTION	INTRAVENOUS	Aug. 27, 2024	NEW PATIENT POPULATION
10MG/ML	BRIVIACT	UCB INC	N205838	May 12, 2016	RX	SOLUTION	ORAL	Aug. 27, 2024	NEW PATIENT POPULATION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Synaptic vesicle glycoprotein 2A	Transporter	Q7L0J3	SV2A_HUMAN	MODULATOR	Ki	7.10		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Synaptic vesicle glycoprotein 2A	Unclassified		SV2A_RAT	INHIBITOR	IC50	7		IUPHAR

External reference:

ID	Source
U863JGG2IA	UNII
D08879	KEGG_DRUG
4035741	VANDF
C1699861	UMLSCUI
CHEBI:133013	CHEBI
CHEMBL607400	ChEMBL_ID
9837243	PUBCHEM_CID
DB05541	DRUGBANK_ID
8642	INN_ID
C482793	MESH_SUPPLEMENTAL_RECORD_UI
9041	IUPHAR_LIGAND_ID
1739745	RXNORM
238946	MMSL
31471	MMSL
d08414	MMSL
016704	NDDF
420813001	SNOMEDCT_US
421052000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-370	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-370	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-370	TABLET, FILM COATED	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-470	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-470	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-470	TABLET, FILM COATED	25 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-570	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-570	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-570	TABLET, FILM COATED	50 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-670	TABLET, FILM COATED	75 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-670	TABLET, FILM COATED	75 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-670	TABLET, FILM COATED	75 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-770	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-770	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-770	TABLET, FILM COATED	100 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-870	SOLUTION	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-870	SOLUTION	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-870	SOLUTION	10 mg	ORAL	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-970	INJECTION, SUSPENSION	50 mg	INTRAVENOUS	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-970	INJECTION, SUSPENSION	50 mg	INTRAVENOUS	NDA	32 sections
Briviact	HUMAN PRESCRIPTION DRUG LABEL	1	50474-970	INJECTION, SUSPENSION	50 mg	INTRAVENOUS	NDA	32 sections