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EXJADE Drug Profile

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Which patents cover Exjade, and what generic alternatives are available?

Exjade is a drug marketed by Novartis and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Exjade

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

Summary for EXJADE

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	102
Clinical Trials:	29
Patent Applications:	546
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXJADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXJADE
DailyMed Link:	EXJADE at DailyMed

See drug prices for EXJADE

Recent Clinical Trials for EXJADE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fondazione Italiana Sindromi Mielodisplastiche Onlus	Phase 2
DisperSol Technologies, LLC	Phase 2
Abramson Cancer Center of the University of Pennsylvania	N/A

See all EXJADE clinical trials

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

Paragraph IV (Patent) Challenges for EXJADE

Tradename	Dosage	Ingredient	NDA	Submissiondate
EXJADE	TABLET, FOR SUSPENSION;ORAL	deferasirox	021882	2011-10-28

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
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	AB	RX	Yes	Yes
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	AB	RX	Yes	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	AB	RX	Yes	Yes
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	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

Expired US Patents for EXJADE

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

International Patents for EXJADE

Country	Patent Number	Estimated Expiration
China	1223579
Brazil	9709973
Portugal	914118
Georgia, Republic of	P20084355
Slovakia	284319
Netherlands	300248
Poland	330119

Supplementary Protection Certificates for EXJADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	290	Finland
0914118	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
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	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	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
0914118	CA 2006 00035	Denmark