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JADENU SPRINKLE Drug Profile

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

Jadenu Sprinkle is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in JADENU SPRINKLE is deferasirox. There are twenty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

US ANDA Litigation and Generic Entry Outlook for Jadenu Sprinkle

A generic version of JADENU SPRINKLE was approved as deferasirox by ACTAVIS ELIZABETH on January 26^th, 2016.

Summary for JADENU SPRINKLE

International Patents:	48
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Patent Applications:	517
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JADENU SPRINKLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JADENU SPRINKLE
DailyMed Link:	JADENU SPRINKLE at DailyMed

See drug prices for JADENU SPRINKLE

Recent Litigation for JADENU SPRINKLE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ALEMBIC PHARMACEUTICALS, LTD v. NOVARTIS PHARMACEUTICALS CORP.	2019-11-27
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.	2016-07-29
Novartis Pharmaceuticals Corporation v. Mylan Inc.	2014-06-26

See all JADENU SPRINKLE litigation

Pharmacology for JADENU SPRINKLE

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 SPRINKLE

1044764-54-6

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-[(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

530D418

A814288

AB0020007

AB0073018

AB01565800_02

AB1008603

AC-8972

ACM1133425758

AK544293

AKOS015855839

AKOS015902587

AKOS025312553

BCP05341

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

DB01609

Deferasirox

Deferasirox (Exjade)

Deferasirox (JAN/USAN/INN)

Deferasirox [USAN:INN:JAN]

Deferasirox [USAN:INN]

Deferasirox, ICL670

Deferasirox(Exjade)

Deferasiroxum

Deferasiroxum [INN-Latin]

DSSTox_CID_28522

DSSTox_GSID_48596

DSSTox_RID_82794

DTXSID1048596

Exjade

Exjade (TN)

F0001-2380

FT-0601564

HMS3655A04

HSDB 7844

HY-17359

ICL 670

ICL 670A

ICL-670

ICL-670A

ICL670

ICL670A

J-013060

Jadenu

Jadenu (TN)

KE-0220

KS-00000G02

LS-186571

LS-187785

MLS003915634

MLS006010080

NCGC00181754-01

NCGC00263572-01

PubChem20503

Q5251502

s1712

SB18926

SCHEMBL1071867

SCHEMBL61756

SCHEMBL62042

SMR002544689

SR-01000931971

SR-01000931971-2

SW219752-1

Tox21_112926

Tox21_112926_1

UNII-V8G4MOF2V9

V0697

V8G4MOF2V9

W-5422

ZINC100022643

ZINC100504305

ZINC100504309

ZINC1481815

ZINC14880008

US Patents and Regulatory Information for JADENU SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017		RX	Yes	No			Y	Y
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017		RX	Yes	Yes			Y	Y
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017		RX	Yes	No			Y	Y
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017		RX	Yes	Yes
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017		RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017		RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017		RX	Yes	No

Expired US Patents for JADENU SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017

International Patents for JADENU SPRINKLE

Country	Patent Number	Estimated Expiration
Israel	127212
Hong Kong	1020530
Slovakia	178598
Hungary	9903111
Poland	330119
Australia	718037
Denmark	0914118

Supplementary Protection Certificates for JADENU SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118	CA 2006 00035	Denmark
0914118	PA2007001	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
0914118	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
0914118	SPC/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.
0914118	PA2007001,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
0914118	06C0049	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