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

Stem definition	Drug id	CAS RN
alpha-2 adrenoreceptor agonists	395	59803-98-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: UK 14,304 mirvaso brimonidine brimonidine tartrate bromoxidine	A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. Molecular weight: 292.14 Formula: C11H10BrN5 CLOGP: 1.49 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 62.20 ALOGS: -3.28 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

UK 14,304
mirvaso
brimonidine
brimonidine tartrate
bromoxidine

A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

Molecular weight: 292.14
Formula: C11H10BrN5
CLOGP: 1.49
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 62.20
ALOGS: -3.28
ROTB: 1

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1.50 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	10 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company
March 25, 2020	PMDA	Senju Pharmaceutical Co., Ltd
Sept. 6, 1996	FDA
Feb. 20, 2014	EMA	GALDERMA INTERNATIONAL

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
Treatment failure	477.58	17.46	332	9995	198711	63279984
Eye irritation	430.23	17.46	154	10173	21817	63456878
Ocular hyperaemia	417.26	17.46	156	10171	24988	63453707
Intraocular pressure increased	400.45	17.46	108	10219	5970	63472725
Eye pain	240.57	17.46	115	10212	33739	63444956
Corneal opacity	135.60	17.46	30	10297	713	63477982
Iridocyclitis	130.05	17.46	37	10290	2485	63476210
Vision blurred	122.91	17.46	109	10218	91815	63386880
Eye pruritus	110.38	17.46	56	10271	18615	63460080
Glaucoma	101.09	17.46	53	10274	18852	63459843
Visual acuity reduced	99.40	17.46	55	10272	21771	63456924
Inappropriate schedule of product administration	93.19	17.46	99	10228	103866	63374829
Dry eye	92.47	17.46	66	10261	40695	63438000
Corneal oedema	86.51	17.46	24	10303	1469	63477226
Foreign body sensation in eyes	85.43	17.46	26	10301	2208	63476487
Erythema of eyelid	84.84	17.46	26	10301	2260	63476435
Rebound effect	78.31	17.46	29	10298	4497	63474198
Erythema	78.27	17.46	118	10209	175633	63303062
Scleral hyperaemia	71.03	17.46	15	10312	284	63478411
Ocular surface disease	69.73	17.46	11	10316	33	63478662
Conjunctival hyperaemia	67.30	17.46	22	10305	2357	63476338
Uveitis	63.72	17.46	34	10293	12519	63466176
Eye swelling	59.51	17.46	41	10286	23877	63454818
Choroidal effusion	53.69	17.46	13	10314	463	63478232
Iris adhesions	52.94	17.46	12	10315	319	63478376
Hypotonia	52.40	17.46	27	10300	9258	63469437
Conjunctivitis allergic	49.37	17.46	14	10313	928	63477767
Eye discharge	47.32	17.46	22	10305	6041	63472654
Vitreous haemorrhage	46.28	17.46	16	10311	2034	63476661
Lacrimation increased	45.83	17.46	33	10294	20598	63458097
Dry mouth	44.55	17.46	59	10268	77804	63400891
Skin burning sensation	44.43	17.46	27	10300	12707	63465988
Visual impairment	43.79	17.46	61	10266	84385	63394310
Corneal deposits	43.35	17.46	10	10317	288	63478407
Intraocular pressure test abnormal	43.05	17.46	9	10318	162	63478533
Eye disorder	43.03	17.46	33	10294	22652	63456043
Eye inflammation	42.71	17.46	20	10307	5579	63473116
Blepharitis	41.84	17.46	16	10311	2709	63475986
Conjunctivitis	41.10	17.46	31	10296	20765	63457930
Meniscus injury	41.05	17.46	21	10306	7093	63471602
Hypersensitivity	40.68	17.46	122	10205	292563	63186132
Conjunctival scar	40.46	17.46	7	10320	42	63478653
Corneal neovascularisation	40.35	17.46	8	10319	109	63478586
Corneal disorder	40.34	17.46	14	10313	1800	63476895
Conjunctival follicles	40.10	17.46	6	10321	11	63478684
Cataract	36.98	17.46	46	10281	57007	63421688
Hypothermia	35.48	17.46	24	10303	13557	63465138
Product quality issue	35.39	17.46	36	10291	35829	63442866
Cystoid macular oedema	34.42	17.46	12	10315	1563	63477132
Visual field defect	33.94	17.46	18	10309	6543	63472152
Product container issue	32.90	17.46	12	10315	1781	63476914
Product delivery mechanism issue	31.14	17.46	8	10319	364	63478331
Eyelids pruritus	30.05	17.46	10	10317	1132	63477563
Photophobia	29.87	17.46	24	10303	17611	63461084
Abnormal sensation in eye	29.50	17.46	11	10316	1738	63476957
Product packaging quantity issue	28.35	17.46	10	10317	1349	63477346
Arthropathy	27.62	17.46	3	10324	234789	63243906
Blindness unilateral	26.42	17.46	15	10312	6226	63472469
Eyelid oedema	26.15	17.46	18	10309	10461	63468234
Maternal exposure during pregnancy	25.41	17.46	3	10324	220059	63258636
Bradycardia	24.16	17.46	43	10284	73184	63405511
Symblepharon	24.13	17.46	5	10322	86	63478609
Eyelid irritation	23.70	17.46	7	10320	536	63478159
Angle closure glaucoma	23.58	17.46	10	10317	2209	63476486
Open angle glaucoma	23.46	17.46	6	10321	268	63478427
Eye colour change	23.06	17.46	6	10321	287	63478408
Pain of skin	22.23	17.46	17	10310	11617	63467078
Accidental exposure to product by child	21.95	17.46	8	10319	1185	63477510
Corneal infiltrates	21.91	17.46	5	10322	137	63478558
Retinal detachment	21.71	17.46	13	10314	5956	63472739
Deep anterior chamber of the eye	21.09	17.46	3	10324	3	63478692
Macular oedema	21.08	17.46	11	10316	3866	63474829
Retinal vascular occlusion	20.82	17.46	6	10321	421	63478274
Intraocular pressure fluctuation	20.65	17.46	4	10323	48	63478647
Ocular discomfort	20.18	17.46	11	10316	4222	63474473
Flat anterior chamber of eye	20.07	17.46	4	10323	56	63478639
Eye haemorrhage	19.81	17.46	14	10313	8482	63470213
Eye operation	19.74	17.46	9	10318	2363	63476332
Vitreous floaters	19.16	17.46	12	10315	5954	63472741
Keratitis interstitial	18.78	17.46	3	10324	10	63478685
Retinopathy haemorrhagic	18.55	17.46	3	10324	11	63478684
Hepatic enzyme increased	18.53	17.46	5	10322	202323	63276372
Endocrine ophthalmopathy	18.15	17.46	6	10321	665	63478030
Joint swelling	18.11	17.46	16	10311	327650	63151045
Vitreous detachment	17.84	17.46	8	10319	2019	63476676
Infusion related reaction	17.57	17.46	9	10318	245512	63233183
Corneal scar	17.55	17.46	4	10323	109	63478586

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
Treatment failure	537.41	18.80	233	6519	46464	34903715
Intraocular pressure increased	395.35	18.80	108	6644	5275	34944904
Ocular hyperaemia	242.61	18.80	89	6663	11363	34938816
Eye irritation	222.27	18.80	75	6677	7486	34942693
Corneal oedema	166.72	18.80	41	6711	1310	34948869
Eye pain	128.03	18.80	59	6693	13403	34936776
Visual acuity reduced	123.74	18.80	61	6691	16088	34934091
Ocular surface disease	123.36	18.80	20	6732	60	34950119
Choroidal detachment	112.57	18.80	24	6728	398	34949781
Corneal opacity	94.08	18.80	22	6730	564	34949615
Hypotony of eye	83.16	18.80	15	6737	97	34950082
Vision blurred	81.63	18.80	69	6683	45894	34904285
Eye pruritus	78.05	18.80	35	6717	7454	34942725
Foreign body sensation in eyes	76.99	18.80	19	6733	615	34949564
Blepharitis	70.05	18.80	21	6731	1424	34948755
Conjunctivitis	66.48	18.80	34	6718	9671	34940508
Iridocyclitis	63.11	18.80	20	6732	1632	34948547
Glaucoma	61.66	18.80	29	6723	6883	34943296
Corneal neovascularisation	59.44	18.80	10	6742	40	34950139
Punctate keratitis	49.15	18.80	12	6740	371	34949808
Conjunctival hyperaemia	48.34	18.80	18	6734	2384	34947795
Choroidal effusion	45.96	18.80	10	6742	183	34949996
Scleral hyperaemia	42.86	18.80	8	6744	64	34950115
Cataract	41.76	18.80	37	6715	26149	34924030
Lacrimation increased	39.43	18.80	23	6729	8459	34941720
Blindness	38.48	18.80	28	6724	14958	34935221
Retinal detachment	37.24	18.80	19	6733	5372	34944807
Eye discharge	36.62	18.80	14	6738	1992	34948187
Corneal infiltrates	36.44	18.80	8	6744	153	34950026
Product delivery mechanism issue	36.10	18.80	8	6744	160	34950019
Visual impairment	35.46	18.80	39	6713	35763	34914416
Hyperaemia	35.13	18.80	12	6740	1237	34948942
Erythema of eyelid	34.28	18.80	11	6741	934	34949245
Pyelitis	33.12	18.80	7	6745	111	34950068
Product container issue	32.91	18.80	10	6742	709	34949470
Dacryostenosis acquired	32.29	18.80	8	6744	263	34949916
Hypersensitivity	31.28	18.80	48	6704	60987	34889192
Cornea verticillata	31.03	18.80	6	6746	59	34950120
Corneal disorder	30.34	18.80	10	6742	924	34949255
Intraocular pressure decreased	30.34	18.80	6	6746	67	34950112
Conjunctival follicles	30.21	18.80	4	6748	0	34950179
Cystoid macular oedema	28.74	18.80	9	6743	706	34949473
Visual field defect	28.66	18.80	15	6737	4468	34945711
Conjunctivitis allergic	28.13	18.80	10	6742	1160	34949019
Dry eye	27.13	18.80	19	6733	9556	34940623
Anterior chamber inflammation	26.81	18.80	7	6745	285	34949894
Eye swelling	26.40	18.80	19	6733	9976	34940203
Thunderclap headache	26.23	18.80	6	6746	139	34950040
Hyphaema	26.17	18.80	8	6744	579	34949600
Visual acuity tests abnormal	25.88	18.80	5	6747	49	34950130
Keratic precipitates	25.65	18.80	6	6746	154	34950025
Open angle glaucoma	25.50	18.80	6	6746	158	34950021
Eyelids pruritus	25.04	18.80	6	6746	171	34950008
Ulcerative keratitis	24.33	18.80	10	6742	1719	34948460
Corneal deposits	23.64	18.80	6	6746	218	34949961
Keratitis interstitial	23.22	18.80	4	6748	19	34950160
Angle closure glaucoma	22.33	18.80	8	6744	949	34949230
Ocular discomfort	22.31	18.80	10	6742	2124	34948055
Corneal degeneration	21.11	18.80	4	6748	35	34950144
Giant papillary conjunctivitis	20.58	18.80	3	6749	3	34950176
Inappropriate schedule of product administration	20.14	18.80	40	6712	62256	34887923
Dermatitis exfoliative generalised	19.78	18.80	11	6741	3696	34946483
Reversible cerebral vasoconstriction syndrome	19.41	18.80	6	6746	451	34949728

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
Intraocular pressure increased	579.75	16.20	156	12124	9049	79723059
Ocular hyperaemia	354.80	16.20	141	12139	28065	79704043
Eye irritation	315.60	16.20	119	12161	20562	79711546
Corneal oedema	235.67	16.20	59	12221	2561	79729547
Eye pain	205.52	16.20	105	12175	37473	79694635
Ocular surface disease	183.73	16.20	29	12251	94	79732014
Visual acuity reduced	171.81	16.20	86	12194	29383	79702725
Vision blurred	150.48	16.20	127	12153	105771	79626337
Blepharitis	107.06	16.20	33	12247	3091	79729017
Foreign body sensation in eyes	105.47	16.20	30	12250	2127	79729981
Choroidal detachment	97.24	16.20	22	12258	614	79731494
Conjunctival hyperaemia	91.99	16.20	32	12248	4381	79727727
Glaucoma	84.78	16.20	47	12233	19714	79712394
Erythema of eyelid	83.23	16.20	26	12254	2544	79729564
Eye pruritus	83.01	16.20	47	12233	20523	79711585
Corneal opacity	81.98	16.20	21	12259	999	79731109
Corneal neovascularisation	80.84	16.20	15	12265	149	79731959
Choroidal effusion	80.02	16.20	19	12261	658	79731450
Iridocyclitis	77.75	16.20	27	12253	3677	79728431
Erythema	77.65	16.20	130	12150	223160	79508948
Inappropriate schedule of product administration	74.22	16.20	97	12183	133531	79598577
Hypotony of eye	74.05	16.20	15	12265	243	79731865
Conjunctivitis allergic	71.12	16.20	21	12259	1699	79730409
Corneal deposits	69.54	16.20	16	12264	482	79731626
Iris adhesions	68.07	16.20	16	12264	530	79731578
Scleral hyperaemia	65.41	16.20	14	12266	300	79731808
Corneal disorder	65.18	16.20	21	12259	2270	79729838
Dry eye	64.46	16.20	50	12230	36881	79695227
Conjunctivitis	63.58	16.20	43	12237	25672	79706436
Conjunctival follicles	62.39	16.20	9	12271	12	79732096
Uveitis	56.15	16.20	34	12246	16796	79715312
Eye discharge	54.99	16.20	24	12256	6010	79726098
Cataract	54.39	16.20	57	12223	62063	79670045
Punctate keratitis	54.06	16.20	15	12265	971	79731137
Rebound effect	53.94	16.20	25	12255	7201	79724907
Retinal detachment	48.08	16.20	25	12255	9222	79722886
Cystoid macular oedema	47.68	16.20	16	12264	1964	79730144
Visual field defect	45.73	16.20	24	12256	9021	79723087
Vitreous haemorrhage	44.67	16.20	18	12262	3695	79728413
Corneal infiltrates	43.50	16.20	10	12270	300	79731808
Skin burning sensation	42.19	16.20	26	12254	13246	79718862
Anterior chamber inflammation	42.16	16.20	11	12269	563	79731545
Angle closure glaucoma	41.31	16.20	16	12264	2960	79729148
Eye inflammation	41.17	16.20	20	12260	6393	79725715
Lacrimation increased	40.46	16.20	31	12249	22446	79709662
Visual impairment	39.36	16.20	59	12221	92072	79640036
Blindness	38.12	16.20	33	12247	28350	79703758
Hypotonia	37.86	16.20	24	12256	12846	79719262
Eyelids pruritus	36.64	16.20	11	12269	942	79731166
Photophobia	36.26	16.20	28	12252	20500	79711608
Open angle glaucoma	34.93	16.20	9	12271	438	79731670
Ulcerative keratitis	34.68	16.20	15	12265	3674	79728434
Hyperaemia	33.74	16.20	14	12266	3096	79729012
Corneal scar	33.07	16.20	8	12272	300	79731808
Dacryostenosis acquired	33.05	16.20	9	12271	543	79731565
Eye disorder	33.02	16.20	28	12252	23384	79708724
Hyphaema	32.89	16.20	10	12270	894	79731214
Flat anterior chamber of eye	32.49	16.20	7	12273	155	79731953
Anterior chamber disorder	32.49	16.20	7	12273	155	79731953
Cornea verticillata	32.11	16.20	7	12273	164	79731944
Eye swelling	32.01	16.20	29	12251	26439	79705669
Keratic precipitates	31.77	16.20	8	12272	355	79731753
Dry mouth	31.53	16.20	52	12228	87967	79644141
Meniscus injury	31.51	16.20	17	12263	6751	79725357
Conjunctival scar	30.45	16.20	7	12273	210	79731898
Keratitis interstitial	30.11	16.20	5	12275	24	79732084
Abnormal sensation in eye	29.00	16.20	11	12269	1924	79730184
Retinal vascular occlusion	27.69	16.20	8	12272	599	79731509
Intraocular pressure test abnormal	27.67	16.20	6	12274	137	79731971
Pyelitis	27.26	16.20	7	12273	336	79731772
Eyelid oedema	27.12	16.20	20	12260	13667	79718441
Giant papillary conjunctivitis	27.07	16.20	4	12276	7	79732101
Trabeculectomy	26.56	16.20	5	12275	54	79732054
Bradycardia	26.44	16.20	62	12218	135495	79596613
Intraocular pressure decreased	26.23	16.20	6	12274	176	79731932
Intraocular pressure fluctuation	25.64	16.20	5	12275	66	79732042
Meibomian gland dysfunction	25.07	16.20	6	12274	215	79731893
Reaction to preservatives	24.50	16.20	6	12274	237	79731871
Dermatitis contact	23.86	16.20	17	12263	11016	79721092
Eyelid ptosis	23.85	16.20	17	12263	11027	79721081
Skin irritation	23.58	16.20	17	12263	11223	79720885
Macular oedema	23.41	16.20	13	12267	5461	79726647
Optic nerve cup/disc ratio increased	23.34	16.20	3	12277	0	79732108
Visual acuity tests abnormal	22.94	16.20	5	12275	117	79731991
Conjunctival oedema	22.61	16.20	8	12272	1150	79730958
Vitreous floaters	22.52	16.20	14	12266	7242	79724866
Corneal epithelium defect	22.14	16.20	7	12273	712	79731396
Dizziness	21.73	16.20	147	12133	526294	79205814
Thunderclap headache	21.46	16.20	6	12274	399	79731709
Blindness unilateral	21.03	16.20	14	12266	8132	79723976
Photopsia	21.00	16.20	12	12268	5324	79726784
Eyelid irritation	20.69	16.20	6	12274	455	79731653
Hypothermia	20.13	16.20	21	12259	22725	79709383
Deep anterior chamber of the eye	20.04	16.20	3	12277	6	79732102
Product quality issue	19.37	16.20	25	12255	33915	79698193
Keratopathy	18.66	16.20	7	12273	1187	79730921
Eyelid disorder	18.45	16.20	8	12272	1970	79730138
Accidental exposure to product by child	18.40	16.20	9	12271	2917	79729191
Prostaglandin analogue periorbitopathy	18.32	16.20	3	12277	13	79732095
Endocrine ophthalmopathy	17.99	16.20	6	12274	722	79731386
Corneal infection	17.99	16.20	4	12276	103	79732005
Pain of skin	17.64	16.20	16	12264	14597	79717511
Floppy iris syndrome	17.53	16.20	5	12275	358	79731750
Brain stem haematoma	17.18	16.20	4	12276	127	79731981
Corneal degeneration	16.89	16.20	4	12276	137	79731971
Panophthalmitis	16.41	16.20	4	12276	155	79731953
Iris atrophy	16.34	16.20	4	12276	158	79731950
Corneal epithelial microcysts	16.34	16.20	3	12277	28	79732080

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D11AX21	DERMATOLOGICALS OTHER DERMATOLOGICAL PREPARATIONS OTHER DERMATOLOGICAL PREPARATIONS Other dermatologicals
ATC	S01EA05	SENSORY ORGANS OPHTHALMOLOGICALS ANTIGLAUCOMA PREPARATIONS AND MIOTICS Sympathomimetics in glaucoma therapy
ATC	S01GA07	SENSORY ORGANS OPHTHALMOLOGICALS DECONGESTANTS AND ANTIALLERGICS Sympathomimetics used as decongestants
FDA MoA	N0000000209	Adrenergic alpha-Agonists
FDA EPC	N0000175552	alpha-Adrenergic Agonist
CHEBI has role	CHEBI:35569	alpha-adrenergic agonists
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:37886	adrenergic agonists
MeSH PA	D018663	Adrenergic Agents
MeSH PA	D000322	Adrenergic Agonists
MeSH PA	D058647	Adrenergic alpha-2 Receptor Agonists
MeSH PA	D000316	Adrenergic alpha-Agonists
MeSH PA	D000959	Antihypertensive Agents
MeSH PA	D002317	Cardiovascular Agents
MeSH PA	D018377	Neurotransmitter Agents

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

Disease	Relation	SNOMED_ID	DOID
Ocular hypertension	indication	4210003	DOID:9282
Open-angle glaucoma	indication	84494001	DOID:1067
Rosacea	indication	398909004	DOID:8881
Bronchospasm	contraindication	4386001
Complete atrioventricular block	contraindication	27885002
Orthostatic hypotension	contraindication	28651003
Acute cerebrovascular insufficiency	contraindication	29322000
Hyperthyroidism	contraindication	34486009	DOID:7998
Depressive disorder	contraindication	35489007
Anaphylaxis	contraindication	39579001
Sinus bradycardia	contraindication	49710005
General anesthesia	contraindication	50697003
Thromboangiitis obliterans	contraindication	52403007	DOID:12918
Cerebrovascular disease	contraindication	62914000	DOID:6713
Diabetes mellitus	contraindication	73211009	DOID:9351
Pulmonary emphysema	contraindication	87433001
Cardiogenic shock	contraindication	89138009
Myasthenia gravis	contraindication	91637004	DOID:437
Acute disease of cardiovascular system	contraindication	128487001
Partial atrioventricular block	contraindication	195039008
Decompensated cardiac failure	contraindication	195111005
Hypoglycemic disorder	contraindication	237630007
Raynaud's phenomenon	contraindication	266261006
Pregnancy, function	contraindication	289908002
Severe chronic obstructive pulmonary disease	contraindication	313299006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.64	Basic
pKa2	1.82	Basic

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
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8859551	May 25, 2024	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8410102	May 24, 2025	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8426410	May 24, 2025	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	7439241	Aug. 25, 2025	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
0.025%	LUMIFY	BAUSCH AND LOMB INC	N208144	Dec. 22, 2017	OTC	SOLUTION/DROPS	OPHTHALMIC	11596600	July 27, 2029	RELIEVES REDNESS OF THE EYE DUE TO MINOR EYE IRRITATIONS
0.025%	LUMIFY	BAUSCH AND LOMB INC	N208144	Dec. 22, 2017	OTC	SOLUTION/DROPS	OPHTHALMIC	8293742	July 14, 2030	RELIEVES REDNESS OF THE EYE DUE TO MINOR EYE IRRITATIONS
0.025%	LUMIFY	BAUSCH AND LOMB INC	N208144	Dec. 22, 2017	OTC	SOLUTION/DROPS	OPHTHALMIC	9259425	July 14, 2030	RELIEVES REDNESS OF THE EYE DUE TO MINOR EYE IRRITATIONS
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8513247	March 25, 2031	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8513249	March 25, 2031	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	9861631	March 25, 2031	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	9861632	March 25, 2031	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
EQ 0.33% BASE	MIRVASO	GALDERMA LABS LP	N204708	Aug. 23, 2013	RX	GEL	TOPICAL	8053427	June 13, 2031	TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN	AGONIST	EC50	8.47	WOMBAT-PK	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN	AGONIST	EC50	8.39	WOMBAT-PK	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN	AGONIST	EC50	7.26	WOMBAT-PK	CHEMBL
Alpha-1B adrenergic receptor	GPCR	P35368	ADA1B_HUMAN		Ki	5.27	CHEMBL
Alpha-1A adrenergic receptor	GPCR	P35348	ADA1A_HUMAN		Ki	5.55	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.84	DRUG MATRIX
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	6.07	DRUG MATRIX
Alpha-2B adrenergic receptor	GPCR		ADA2B_RAT		Ki	7.28	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	5.59	CHEMBL
Alpha-1A adrenergic receptor	GPCR		ADA1A_BOVIN		EC50	5.95	CHEMBL
Adrenergic receptor alpha-2	GPCR		ADA2B_RAT ADA2C_RAT ADA2A_RAT		Ki	7.52	CHEMBL
Adrenergic receptor alpha-1	GPCR		ADA1B_RAT ADA1D_RAT ADA1A_RAT		Ki	6.13	CHEMBL
Alpha-1B adrenergic receptor	GPCR		G3HDX1_CRIGR		EC50	6.03	CHEMBL

External reference:

ID	Source
E6GNX3HHTE	UNII
D02076	KEGG_DRUG
70359-46-5	SECONDARY_CAS_RN
134615	RXNORM
C0525227	UMLSCUI
CHEBI:3175	CHEBI
J59	PDB_CHEM_ID
CHEMBL844	ChEMBL_ID
2435	PUBCHEM_CID
DB00484	DRUGBANK_ID
CHEMBL2062257	ChEMBL_ID
D000068438	MESH_DESCRIPTOR_UI
6863	INN_ID
520	IUPHAR_LIGAND_ID
14807	MMSL
205316	MMSL
240890	MMSL
31659	MMSL
4297	MMSL
44062	MMSL
46686	MMSL
108827001	SNOMEDCT_US
372547000	SNOMEDCT_US
386924004	SNOMEDCT_US
4021002	VANDF
4024043	VANDF
006196	NDDF
006197	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ALPHAGAN P	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9177	SOLUTION/ DROPS	1.50 mg	OPHTHALMIC	NDA	25 sections
ALPHAGAN P	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9177	SOLUTION/ DROPS	1.50 mg	OPHTHALMIC	NDA	25 sections
COMBIGAN	HUMAN PRESCRIPTION DRUG LABEL	2	0023-9211	SOLUTION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
COMBIGAN	HUMAN PRESCRIPTION DRUG LABEL	2	0023-9211	SOLUTION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
ALPHAGAN P	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9321	SOLUTION/ DROPS	1 mg	OPHTHALMIC	NDA	25 sections
ALPHAGAN P	HUMAN PRESCRIPTION DRUG LABEL	1	0023-9321	SOLUTION/ DROPS	1 mg	OPHTHALMIC	NDA	25 sections
SIMBRINZA	HUMAN PRESCRIPTION DRUG LABEL	2	0065-4147	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
SIMBRINZA	HUMAN PRESCRIPTION DRUG LABEL	2	0065-4147	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
SIMBRINZA	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0904	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
SIMBRINZA	HUMAN PRESCRIPTION DRUG LABEL	2	0078-0904	SUSPENSION/ DROPS	2 mg	OPHTHALMIC	NDA	26 sections
Mirvaso	HUMAN PRESCRIPTION DRUG LABEL	1	0299-5980	GEL	5 mg	TOPICAL	NDA	26 sections
Mirvaso	HUMAN PRESCRIPTION DRUG LABEL	1	0299-5980	GEL	5 mg	TOPICAL	NDA	26 sections
Brimonidine Tartrate/Timolol Maleate	HUMAN PRESCRIPTION DRUG LABEL	2	0591-2422	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	22 sections
Brimonidine Tartrate and Timolol Maleate	HUMAN PRESCRIPTION DRUG LABEL	2	0781-7186	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	23 sections
Brimonidine Tartrate and Timolol Maleate	HUMAN PRESCRIPTION DRUG LABEL	2	0781-7186	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	23 sections
Brimonidine Tartrate and Timolol Maleate	HUMAN PRESCRIPTION DRUG LABEL	2	0832-1425	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	27 sections
Brimonidine Tartrate	Human Prescription Drug Label	1	14445-400	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	24 sections
BRIMONIDINE TARTRATE	HUMAN PRESCRIPTION DRUG LABEL	1	16590-883	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	12 sections
Brimonidine	HUMAN PRESCRIPTION DRUG LABEL	1	17478-715	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	25 sections
Brimonidine	HUMAN PRESCRIPTION DRUG LABEL	1	17478-715	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	25 sections
Brimonidine Tartrate	HUMAN PRESCRIPTION DRUG LABEL	1	24208-411	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	22 sections
Brimonidine Tartrate	HUMAN PRESCRIPTION DRUG LABEL	1	24208-411	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	22 sections
Brimonidine Tartrate	HUMAN PRESCRIPTION DRUG LABEL	1	24208-411	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	22 sections
LUMIFY Redness Reliever Eye Drops	HUMAN OTC DRUG LABEL	1	24208-537	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	13 sections
LUMIFY Redness Reliever Eye Drops	HUMAN OTC DRUG LABEL	1	24208-537	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	13 sections
LUMIFY Redness Reliever Eye Drops	HUMAN OTC DRUG LABEL	1	24208-537	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	13 sections
LUMIFY Redness Reliever Eye Drops	HUMAN OTC DRUG LABEL	1	24208-537	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	13 sections
Brimonidine Tartrate	HUMAN PRESCRIPTION DRUG LABEL	1	25685-715	SOLUTION/ DROPS	2 mg	OPHTHALMIC	ANDA	12 sections
BRIMONIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	45802-078	GEL	5 mg	TOPICAL	ANDA	26 sections
Brimonidine Tartrate ophthalmic solution, 0.15%	Human Prescription Drug Label	1	46708-661	SOLUTION/ DROPS	1.50 mg	OPHTHALMIC	ANDA	24 sections