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Deferasirox - Generic Drug Details

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What are the generic drug sources for deferasirox and what is the scope of deferasirox patent protection?

Deferasirox is the generic ingredient in four branded drugs marketed by Novartis Pharms Corp, Actavis Elizabeth, and Novartis, and is included in four NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has seventy-six patent family members in forty-eight countries.

There are twenty drug master file entries for deferasirox. One supplier is listed for this compound.

Summary for deferasirox

International Patents:	76
US Patents:	2
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	20
Suppliers / Packagers:	1
Bulk Api Vendors:	91
Clinical Trials:	86
Patent Applications:	762
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deferasirox
DailyMed Link:	deferasirox at DailyMed

Pharmacology for deferasirox

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity Cytochrome P450 3A4 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 1A2 Inhibitors

Synonyms for deferasirox

1044764-54-6

1133425-75-8

201530-41-8

4-((3E,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl)benzoic acid

4-((3Z,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl)benzoic acid

4-(3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)benzoic acid

4-[(3E,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid

4-[(3Z,5E)-3,5-Bis(6-Oxo-2,4-cyclohexadien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid, AldrichCPR

4-[(3Z,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid

4-[3,5-bis(2-hydroxyphenyl)

4-[3,5-Bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid

4-[3,5-Bis(2-hydroxyphenyl)-1,2,4-triazol-1-yl]benzoic acid

4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid

4-[3,5-bis(6-oxidanylidenecyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid

4-[3,5-bis(6-oxo-1-cyclohexa-2,4-dienylidene)-1,2,4-triazolidin-1-yl]benzoic acid

4-{5-[(1E)-6-OXOCYCLOHEXA-2,4-DIEN-1-YLIDENE]-3-[(1Z)-6-OXOCYCLOHEXA-2,4-DIEN-1-YLIDENE]-1,2,4-TRIAZOLIDIN-1-YL}BENZOIC ACID

530D418

A814288

AB0020007

AB0073018

AB01565800_02

AB1008603

AC-8972

AC1NUU0E

AC1O1JMP

ACM1133425758

AKOS015855839

AKOS015902587

AKOS025312553

AN-5418

BC677677

BCP9000594

BDBM50088376

Benzoic acid, 4-(3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)-

Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-

BOFQWVMAQOTZIW-UHFFFAOYSA-N

C21H15N3O4

CAS-201530-41-8

CGP-72670

CHEBI:49005

CHEMBL550348

CS-0901

CTK8F0690

D03669

D0Q5UQ

DB01609

Deferasirox (Exjade)

Deferasirox (JAN/USAN/INN)

Deferasirox [USAN:INN:JAN]

Deferasirox [USAN:INN]

Deferasirox-d4

Deferasirox, ICL670

Deferasiroxum

Deferasiroxum [INN-Latin]

DR002074

DSSTox_CID_28522

DSSTox_GSID_48596

DSSTox_RID_82794

DTXSID1048596

Exjade

Exjade (TN)

F0001-2380

FT-0601564

HE297142

HE323479

HMS3655A04

HSDB 7844

HY-17359

I14-1968

ICL 670

ICL 670A

ICL-670

ICL-670A

ICL670

ICL670A

J-013060

Jadenu

Jadenu (TN)

Jadenu Sprinkle

KB-49640

KE-0220

KS-00000G02

LS-186571

LS-187785

MFCD09751362

MFCD09951804

MLS003915634

MLS006010080

MolPort-006-392-553

MolPort-028-744-623

NCGC00181754-01

NCGC00263572-01

PubChem20503

s1712

SCHEMBL1071867

SCHEMBL61756

SCHEMBL62042

SMR002544689

SR-01000931971

SR-01000931971-2

Tox21_112926

Tox21_112926_1

UNII-V8G4MOF2V9

V0697

V8G4MOF2V9

W-5422

ZINC100022643

ZINC100504305

ZINC100504309

ZINC1481815

ZINC14880008

US Patents and Regulatory Information for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015		RX	Yes	No			Y	Y
Novartis Pharms Corp	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017		RX	Yes	No			Y	Y
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	AB	RX	Yes	No

Expired US Patents for deferasirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015

International Patents for deferasirox

Country	Document Number	Estimated Expiration
South Africa	201506060
South Korea	20050098029
European Patent Office	3124018
Israel	127212

Supplementary Protection Certificates for deferasirox

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0248	Netherlands		300248, 20170624, EXPIRES: 20210827
2007001,C0914118	Lithuania		PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
C 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
2006 00035	Denmark