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EXJADE Drug Profile

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When do Exjade patents expire, and when can generic versions of Exjade launch?

Exjade is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-eight patent family members in thirty-four countries.

The generic ingredient in EXJADE is deferasirox. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deferasirox profile page.

Summary for EXJADE

International Patents:	48
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	83
Clinical Trials:	27
Patent Applications:	398
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	EXJADE at DailyMed

Pharmacology for EXJADE

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

Synonyms for EXJADE

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

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 (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 EXJADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	AB	RX	Yes	No			Y	Y
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	AB	RX	Yes	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	AB	RX	Yes	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	AB	RX	Yes	No			Y	Y

Expired US Patents for EXJADE

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

Paragraph IV (Patent) Challenges for EXJADE

Drugname	Dosage	Strength	RLD	Submissiondate
	Tablets	125 mg, 250 mg, and 500 mg		2011-10-28

Non-Orange Book US Patents for EXJADE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,596,750	Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
6,723,742	Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators

International Patents for EXJADE

Country	Document Number	Estimated Expiration
Poland	330119
Czech Republic	291470
Cyprus	2429
Bulgaria	103003

Supplementary Protection Certificates for EXJADE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB07/002	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
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
0	Finland