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

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibufenac derivatives	401	91714-94-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: yellox bromfenac sodium sesquihydrate prolensa bromfenac xibrom bromfenac sodium	Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2, prostaglandins are mediators of certain kinds of intraocular inflammation. Molecular weight: 334.17 Formula: C15H12BrNO3 CLOGP: 3.28 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 80.39 ALOGS: -4.42 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

yellox
bromfenac sodium sesquihydrate
prolensa
bromfenac
xibrom
bromfenac sodium

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2, prostaglandins are mediators of certain kinds of intraocular inflammation.

Molecular weight: 334.17
Formula: C15H12BrNO3
CLOGP: 3.28
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 80.39
ALOGS: -4.42
ROTB: 4

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	67 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	4.28 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
t_half (Half-life)	2.60 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
CL (Clearance)	1.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.11 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.01 mg/mL	Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
March 24, 2005	FDA	BAUSCH AND LOMB INC

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
Corneal oedema	112.11	33.46	20	1142	1473	63486387
Endophthalmitis	88.88	33.46	19	1143	3573	63484287
Hypopyon	83.42	33.46	14	1148	718	63487142
Cataract	82.45	33.46	33	1129	57020	63430840
Eye irritation	78.91	33.46	25	1137	21946	63465914
Toxic anterior segment syndrome	77.19	33.46	15	1147	1756	63486104
Eye pain	60.96	33.46	23	1139	33831	63454029
Product packaging quantity issue	56.09	33.46	11	1151	1348	63486512
Corneal opacity	49.50	33.46	9	1153	734	63487126
Corneal infiltrates	48.31	33.46	7	1155	135	63487725

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FDA Adverse Event Reporting System (Male)

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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
Cataract	82.17	41.10	26	537	26160	34930208
Hypopyon	63.67	41.10	10	553	386	34955982
Toxic anterior segment syndrome	59.20	41.10	11	552	1158	34955210
Eye pain	57.62	41.10	17	546	13445	34942923
Endophthalmitis	52.49	41.10	12	551	3496	34952872
Corneal oedema	51.41	41.10	10	553	1341	34955027
Ulcerative keratitis	48.95	41.10	10	553	1719	34954649

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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
Corneal oedema	153.62	30.64	28	1287	2592	79740481
Endophthalmitis	145.50	30.64	31	1284	6397	79736676
Hypopyon	140.70	30.64	23	1292	1119	79741954
Toxic anterior segment syndrome	132.96	30.64	25	1290	2739	79740334
Eye pain	95.22	30.64	32	1283	37546	79705527
Cataract	86.52	30.64	34	1281	62086	79680987
Corneal opacity	80.23	30.64	14	1301	1006	79742067
Corneal disorder	68.92	30.64	14	1301	2277	79740796
Ulcerative keratitis	67.76	30.64	15	1300	3674	79739399
Corneal infiltrates	65.83	30.64	10	1305	300	79742773

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	S01BC11	SENSORY ORGANS OPHTHALMOLOGICALS ANTIINFLAMMATORY AGENTS Antiinflammatory agents, non-steroids
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents
MeSH PA	D000894	Anti-Inflammatory Agents, Non-Steroidal
MeSH PA	D018501	Antirheumatic Agents

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

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Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Postoperative Ocular Pain	indication
Post-Op Ocular Inflammation	indication
Rheumatoid arthritis	contraindication	69896004	DOID:7148
Diabetes mellitus	contraindication	73211009	DOID:9351
Red eye	contraindication	75705005
Epithelial Keratopathy	contraindication

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.32	acidic
pKa2	3.17	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
EQ 0.07% ACID	PROLENSA	BAUSCH AND LOMB	N203168	April 5, 2013	RX	SOLUTION/DROPS	OPHTHALMIC	8927606	Jan. 16, 2024	METHOD OF TREATING OCULAR INFLAMMATION
EQ 0.07% ACID	PROLENSA	BAUSCH AND LOMB	N203168	April 5, 2013	RX	SOLUTION/DROPS	OPHTHALMIC	8927606	Jan. 16, 2024	METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
EQ 0.07% ACID	PROLENSA	BAUSCH AND LOMB	N203168	April 5, 2013	RX	SOLUTION/DROPS	OPHTHALMIC	9561277	Jan. 16, 2024	TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY
EQ 0.07% ACID	PROLENSA	BAUSCH AND LOMB	N203168	April 5, 2013	RX	SOLUTION/DROPS	OPHTHALMIC	9517220	Nov. 11, 2033	TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS WHO HAVE UNDERGONE CATARACT SURGERY
EQ 0.075% ACID	BROMSITE	SUN PHARM	N206911	April 8, 2016	RX	SOLUTION/DROPS	OPHTHALMIC	8778999	Aug. 7, 2029	TREATMENT OF POSTOPERATIVE INFLAMMATION AND PREVENTION OF OCULAR PAIN IN PATIENTS UNDERGOING CATARACT SURGERY

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	8.40	WOMBAT-PK	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN	INHIBITOR	IC50	8.29	WOMBAT-PK	CHEMBL
Cyclooxygenase	Enzyme		PGH1_BOVIN PGH2_BOVIN		IC50	7.10	CHEMBL

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External reference:

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ID	Source
27R	PDB_CHEM_ID
006757	NDDF
006758	NDDF
108520008	SNOMEDCT_US
108521007	SNOMEDCT_US
120638-55-3	SECONDARY_CAS_RN
1375918	RXNORM
181436	MMSL
200626	MMSL
31652	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bromday	HUMAN PRESCRIPTION DRUG LABEL	1	50436-6301	SOLUTION/ DROPS	0.90 mg	OPHTHALMIC	NDA	22 sections
Bromday	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6301	SOLUTION/ DROPS	0.90 mg	OPHTHALMIC	NDA	22 sections
bromfenac	Human Prescription Drug Label	1	46708-508	SOLUTION/ DROPS	1.04 mg	OPHTHALMIC	ANDA	22 sections
bromfenac	HUMAN PRESCRIPTION DRUG LABEL	1	50383-249	SOLUTION/ DROPS	1.04 mg	OPHTHALMIC	ANDA	25 sections
bromfenac	HUMAN PRESCRIPTION DRUG LABEL	1	50383-249	SOLUTION/ DROPS	1.04 mg	OPHTHALMIC	ANDA	25 sections
Bromfenac	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6343	SOLUTION/ DROPS	1.04 mg	OPHTHALMIC	ANDA	23 sections
Bromfenac	Human Prescription Drug Label	1	65862-789	SOLUTION/ DROPS	0.90 mg	OPHTHALMIC	ANDA	22 sections
BROMFENAC	Human Prescription Drug Label	1	68083-313	SOLUTION/ DROPS	0.90 mg	OPHTHALMIC	ANDA	22 sections
BROMFENAC	HUMAN PRESCRIPTION DRUG LABEL	1	72266-142	SOLUTION/ DROPS	0.90 mg	OPHTHALMIC	ANDA	22 sections
Bromfenac Ophthalmic Solution 0.09%	Human Prescription Drug Label	1	62332-508	SOLUTION/ DROPS	1.04 mg	OPHTHALMIC	ANDA	22 sections

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