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

Stem definition	Drug id	CAS RN
	4188	30652-11-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: deferiprone deferione ferriprox	a chelating agent with an affinity for ferric ion (iron III) indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes Molecular weight: 139.15 Formula: C7H9NO2 CLOGP: -0.90 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 40.54 ALOGS: 0.29 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

deferiprone
deferione
ferriprox

a chelating agent with an affinity for ferric ion (iron III) indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes

Molecular weight: 139.15
Formula: C7H9NO2
CLOGP: -0.90
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 40.54
ALOGS: 0.29
ROTB: 0

Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Aug. 25, 1999	EMA	APOTEX EUROPE BV
Oct. 14, 2011	FDA	APOPHARMA 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
Agranulocytosis	265.70	36.74	67	1155	25067	63462733
Sickle cell anaemia with crisis	188.79	36.74	39	1183	5964	63481836
Neutropenia	78.38	36.74	46	1176	174959	63312841
Serum ferritin increased	62.64	36.74	16	1206	6166	63481634
Death	45.23	36.74	45	1177	374336	63113464
Off label use	42.65	36.74	58	1164	674404	62813396

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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
Agranulocytosis	150.14	31.78	46	940	23775	34932170
Neutropenia	57.70	31.78	42	944	156736	34799209
Death	56.52	31.78	62	924	397987	34557958
Sickle cell anaemia with crisis	44.03	31.78	12	974	4041	34951904

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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
Agranulocytosis	390.14	33.37	106	1704	44924	79697654
Sickle cell anaemia with crisis	144.73	33.37	34	1776	7888	79734690
Neutropenia	131.05	33.37	81	1729	287629	79454949
Death	103.66	33.37	92	1718	566422	79176156
Serum ferritin increased	61.31	33.37	18	1792	9829	79732749
Off label use	39.47	33.37	72	1738	907143	78835435

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	V03AC02	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Iron chelating agents
CHEBI has role	CHEBI:38157	iron chelating agents
CHEBI has role	CHEBI:50267	protective agents
FDA EPC	N0000175522	Iron Chelator
FDA MoA	N0000000144	Iron Chelating Activity
MeSH PA	D002614	Chelating Agents
MeSH PA	D007502	Iron Chelating Agents
MeSH PA	D064449	Sequestering Agents

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

Disease	Relation	SNOMED_ID	DOID
Iron overload	indication	60737008
beta Thalassemia	indication	65959000	DOID:12241

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.54	acidic

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/ML	FERRIPROX	CHIESI	N208030	Sept. 9, 2015	RX	SOLUTION	ORAL	8703156	Oct. 26, 2029	METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
1GM	FERRIPROX	CHIESI	N212269	May 19, 2020	RX	TABLET	ORAL	10780055	Oct. 25, 2038	METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
1GM	FERRIPROX	CHIESI	N212269	May 19, 2020	RX	TABLET	ORAL	10940115	Oct. 25, 2038	METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
1GM	FERRIPROX	CHIESI	N212269	May 19, 2020	RX	TABLET	ORAL	11357731	Oct. 25, 2038	METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD
80MG/ML	FERRIPROX	CHIESI	N208030	April 20, 2018	DISCN	SOLUTION	ORAL	8703156	Oct. 26, 2029	METHOD OF TREATING TRANSFUSIONAL IRON OVERLOAD

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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/ML	FERRIPROX	CHIESI	N208030	Sept. 9, 2015	RX	SOLUTION	ORAL	April 30, 2024	TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS
100MG/ML	FERRIPROX	CHIESI	N208030	Sept. 9, 2015	RX	SOLUTION	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS
100MG/ML	FERRIPROX	CHIESI	N208030	Sept. 9, 2015	RX	SOLUTION	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011
100MG/ML	FERRIPROX	CHIESI	N208030	Sept. 9, 2015	RX	SOLUTION	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
1GM	FERRIPROX	CHIESI	N021825	July 25, 2019	RX	TABLET	ORAL	April 30, 2024	TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS
1GM	FERRIPROX	CHIESI	N212269	May 19, 2020	RX	TABLET	ORAL	April 30, 2024	TREATMENT OF PATIENTS WITH TRANSFUSIONAL IRON OVERLOAD DUE TO SICKLE CELL DISEASE OR OTHER ANEMIAS
1GM	FERRIPROX	CHIESI	N021825	July 25, 2019	RX	TABLET	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS
1GM	FERRIPROX	CHIESI	N021825	July 25, 2019	RX	TABLET	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT PATIENTS WITH THALASSEMIA SYNDROMES EXCLUDING ADULT PATIENTS COVERED BY THE INDICATION FOR THALASSEMIA SYNDROMES APPROVED ON OCTOBER 14, 2011
1GM	FERRIPROX	CHIESI	N021825	July 25, 2019	RX	TABLET	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH THALASSEMIA SYNDROMES
1GM	FERRIPROX	CHIESI	N212269	May 19, 2020	RX	TABLET	ORAL	April 30, 2028	TREATMENT OF TRANSFUSIONAL IRON OVERLOAD IN ADULT AND PEDIATRIC PATIENTS 8 YEARS OF AGE AND OLDER WITH SICKLE CELL DISEASE OR OTHER ANEMIAS

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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
Deoxyhypusine hydroxylase	Enzyme	Q9BU89	DOHH_HUMAN		IC50	5.30		CHEMBL

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External reference:

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ID	Source
007561	NDDF
11645	RXNORM
117386	MMSL
18035	MMSL
2972	PUBCHEM_CID
2BTY8KH53L	UNII
329482000	SNOMEDCT_US
396011004	SNOMEDCT_US
4031179	VUID
4031179	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Deferiprone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0576	TABLET, COATED	500 mg	ORAL	ANDA	28 sections
Deferiprone	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0711	TABLET, COATED	1000 mg	ORAL	ANDA	28 sections
Deferiprone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4196	TABLET	500 mg	ORAL	ANDA	32 sections
Deferiprone	HUMAN PRESCRIPTION DRUG LABEL	1	51672-4196	TABLET	500 mg	ORAL	ANDA	32 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-100	TABLET, FILM COATED	500 mg	ORAL	NDA	28 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-100	TABLET, FILM COATED	500 mg	ORAL	NDA	28 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-100	TABLET, FILM COATED	500 mg	ORAL	NDA	28 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-101	SOLUTION	100 mg	ORAL	NDA	29 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-103	TABLET, FILM COATED	1000 mg	ORAL	NDA	30 sections
FERRIPROX	HUMAN PRESCRIPTION DRUG LABEL	1	10122-103	TABLET, FILM COATED	1000 mg	ORAL	NDA	30 sections

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