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JADENU Drug Profile

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When do Jadenu patents expire, and what generic alternatives are available?

Jadenu is a drug marketed by Novartis Pharms Corp and is included in two NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in JADENU 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 JADENU

US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	39
Clinical Trials:	1
Patent Applications:	416
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JADENU
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JADENU
DailyMed Link:	JADENU at DailyMed

Pharmacology for JADENU

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

Synonyms for JADENU

1044764-54-6

201530-41-8

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-[(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)-1H-1,2,4-triazol-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

AB0073018

AB01565800_02

AB1008603

AC1NUU0E

AKOS015855839

AN-5418

BCP9000594

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

C21H15N3O4

CAS-201530-41-8

CGP-72670

D03669

D0Q5UQ

DB01609

Deferasirox

Deferasirox (Exjade)

Deferasirox (JAN/USAN/INN)

Deferasirox [USAN:INN:JAN]

Deferasirox [USAN:INN]

Deferasiroxum

Deferasiroxum [INN-Latin]

DR002074

DSSTox_CID_28522

DSSTox_GSID_48596

DSSTox_RID_82794

DTXSID1048596

Exjade

Exjade (TN)

HE323479

HSDB 7844

ICL 670

ICL 670A

ICL-670

ICL-670A

ICL670

J-013060

Jadenu (TN)

Jadenu Sprinkle

LS-186571

LS-187785

MFCD09751362

MFCD09951804

NCGC00181754-01

NCGC00263572-01

PubChem20503

s1712

SCHEMBL62042

Tox21_112926

Tox21_112926_1

UNII-V8G4MOF2V9

V0697

V8G4MOF2V9

W-5422

ZINC14880008

US Patents and Regulatory Information for JADENU

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	206910-001	Mar 30, 2015		RX	Yes	No			Y	Y
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	207968-003	May 18, 2017		RX	Yes	Yes			Y	Y

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Expired US Patents for JADENU

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 Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015

Paragraph IV (Patent) Challenges for JADENU

Drugname	Dosage	Strength	RLD	Date
	Tablets	180 mg
	Tablets	90 mg and 360 mg
	Tablets	180 mg

Non-Orange Book US Patents for JADENU

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

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International Patents for JADENU

Country	Document Number	Estimated Expiration
South Africa	201506060
Czech Republic	9804272
China	1146415
Mexico	2015011962

Supplementary Protection Certificates for JADENU

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0	Finland
C 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
2007001	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
C0049	France		PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828