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

Stem definition	Drug id	CAS RN
	4224	53179-13-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pirfenidone esbriet glaspia	pyridone, indicated for the treatment of idiopathic pulmonary fibrosis Molecular weight: 185.23 Formula: C12H11NO CLOGP: 2.10 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 20.31 ALOGS: -1.81 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pirfenidone
esbriet
glaspia

pyridone, indicated for the treatment of idiopathic pulmonary fibrosis

Molecular weight: 185.23
Formula: C12H11NO
CLOGP: 2.10
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 20.31
ALOGS: -1.81
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2.40	g	O

ADMET properties:

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Property	Value	Reference
fu (Fraction unbound in plasma)	0.39 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

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Date	Agency	Company
Feb. 28, 2011	EMA	Roche Registration Limited
Oct. 15, 2014	FDA	GENENTECH INC
Sept. 16, 2008	PMDA

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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
Death	804.09	27.00	607	10894	373774	63103747
Nausea	413.42	27.00	626	10875	853845	62623676
Decreased appetite	318.12	27.00	302	11199	250750	63226771
Weight decreased	155.25	27.00	219	11282	276579	63200942
No adverse event	154.03	27.00	95	11406	41310	63436211
Dyspepsia	148.35	27.00	133	11368	102063	63375458
Cough	140.13	27.00	215	11286	292528	63184993
Pulmonary function test abnormal	133.14	27.00	36	11465	1794	63475727
Photosensitivity reaction	131.68	27.00	61	11440	14933	63462588
Forced vital capacity decreased	121.24	27.00	30	11471	1049	63476472

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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
Death	2328.96	23.77	1919	19776	396130	34539106
Decreased appetite	609.90	23.77	625	21070	165767	34769469
Photosensitivity reaction	433.00	23.77	183	21512	10411	34924825
Weight decreased	302.76	23.77	453	21242	175848	34759388
Dyspnoea	259.75	23.77	657	21038	376125	34559111
Sunburn	249.23	23.77	77	21618	1746	34933490
Nausea	242.74	23.77	601	21094	339307	34595929
Fatigue	233.39	23.77	625	21070	370028	34565208
Pulmonary function test abnormal	229.84	23.77	79	21616	2531	34932705
Pulmonary function test decreased	220.16	23.77	91	21604	4884	34930352

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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
Death	1682.68	22.91	1373	22817	565141	79155057
Decreased appetite	754.61	22.91	704	23486	341714	79378484
Photosensitivity reaction	387.69	22.91	168	24022	20959	79699239
Nausea	357.77	22.91	848	23342	956348	78763850
Pulmonary function test abnormal	343.48	22.91	101	24089	4043	79716155
Weight decreased	338.74	22.91	474	23716	354724	79365474
Pulmonary function test decreased	309.49	22.91	108	24082	7529	79712669
Dyspnoea	307.49	22.91	748	23442	856277	78863921
Dyspepsia	280.29	22.91	245	23945	108442	79611756
Oxygen saturation decreased	262.98	22.91	255	23935	128792	79591406

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L04AX05	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Other immunosuppressants
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35493	anti-pyretic
FDA CS	M0018236	Pyridones
FDA EPC	N0000191420	Pyridone
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	D000970	Antineoplastic 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
Idiopathic pulmonary fibrosis	indication	700250006	DOID:0050156
Severe hepatic impairment	contraindication	59927004
Severe renal impairment	contraindication	236423003
End stage renal failure	contraindication	236435004
Fluvoxamine	contraindication	372905008
End stage liver disease	contraindication	708248004

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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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
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	7767225	Sept. 22, 2026	METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	7988994	Sept. 22, 2026	METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	8753679	Sept. 22, 2026	METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	7696236	Dec. 18, 2027	DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	7767700	Dec. 18, 2027	DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	8420674	Dec. 18, 2027	DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
267MG	ESBRIET	GENENTECH INC	N208780	Jan. 11, 2017	RX	TABLET	ORAL	7767700	Dec. 18, 2027	PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF IPF AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG	ESBRIET	GENENTECH INC	N208780	Jan. 11, 2017	RX	TABLET	ORAL	8420674	Dec. 18, 2027	PIRFENIDONE DOSE ESCALATION REGIMEN FOR TREATMENT OF FIBROSIS AS 801 MG/DAY FOR DAYS 1-7 OF THE REGIMEN, 1602 MG/DAY FOR DAYS 8-14 OF THE REGIMEN, AND 2403 MG/DAY FOR AT LEAST DAY 15 OF THE REGIMEN
267MG	ESBRIET	GENENTECH INC	N022535	Oct. 15, 2014	RX	CAPSULE	ORAL	8383150	May 10, 2028	METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
267MG	ESBRIET	GENENTECH INC	N208780	Jan. 11, 2017	RX	TABLET	ORAL	8383150	May 10, 2028	METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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External reference:

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ID	Source
014994	NDDF
1592254	RXNORM
198886	MMSL
29209	MMSL
354385	MMSL
3825	INN_ID
4033815	VUID
4033815	VANDF
40632	PUBCHEM_CID
438240001	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0480-3610	TABLET, FILM COATED	267 mg	ORAL	ANDA	27 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0480-3611	TABLET, FILM COATED	801 mg	ORAL	ANDA	27 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-2158	CAPSULE	267 mg	ORAL	ANDA	28 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8085	TABLET, FILM COATED	267 mg	ORAL	ANDA	28 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8085	TABLET, FILM COATED	267 mg	ORAL	ANDA	28 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8086	TABLET, FILM COATED	801 mg	ORAL	ANDA	28 sections
Pirfenidone	HUMAN PRESCRIPTION DRUG LABEL	1	0781-8086	TABLET, FILM COATED	801 mg	ORAL	ANDA	28 sections
PIRFENIDONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-467	TABLET, FILM COATED	267 mg	ORAL	ANDA	28 sections
PIRFENIDONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-467	TABLET, FILM COATED	267 mg	ORAL	ANDA	28 sections
PIRFENIDONE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-468	TABLET, FILM COATED	801 mg	ORAL	ANDA	28 sections

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