DrugPatentWatch Database Preview

Deferasirox - Generic Drug Details

« Back to Dashboard

What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Novartis, Actavis Elizabeth, and Novartis Pharms Corp, 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 one hundred and four patent family members in fifty countries.

There are twenty drug master file entries for deferasirox. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for deferasirox

International Patents:	104
US Patents:	2
Tradenames:	4
Applicants:	3
NDAs:	4
Drug Master File Entries:	20
Suppliers / Packagers:	2
Bulk Api Vendors:	100
Clinical Trials:	87
Patent Applications:	908
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deferasirox
DailyMed Link:	deferasirox at DailyMed

Recent Clinical Trials for deferasirox

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

Sponsor	Phase
Fondazione Italiana Sindromi Mielodisplastiche Onlus	Phase 2
DisperSol Technologies, LLC	Phase 2
Fred Hutchinson Cancer Research Center	Phase 2

See all deferasirox clinical trials

Recent Litigation for deferasirox

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.	2016-07-29
Novartis Pharmaceuticals Corporation v. Mylan Inc.	2014-06-26
Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc.	2014-06-25

See all deferasirox litigation

Generic filers with tentative approvals for DEFERASIROX

Applicant	Application No.	Strength	Dosage Form
		360MG	TABLET;ORAL
		180MG	TABLET;ORAL
		90MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Paragraph IV (Patent) Challenges for DEFERASIROX

Tradename	Dosage	Ingredient	NDA	Submissiondate
JADENU	TABLET;ORAL	deferasirox	206910	2016-04-21
JADENU	TABLET;ORAL	deferasirox	206910	2015-10-19
EXJADE	TABLET, FOR SUSPENSION;ORAL	deferasirox	021882	2011-10-28

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	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	021882-002	Nov 2, 2005	AB	RX	Yes	No			Y	Y
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015		RX	Yes	No			Y	Y
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015		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 deferasirox

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	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015
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	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017

International Patents for deferasirox

Country	Patent Number	Estimated Expiration
Mexico	361055
Denmark	2964202
European Patent Office	0914118
Spain	2708955
Slovenia	3124018
Germany	122007000020
Philippines	12015501981

Supplementary Protection Certificates for deferasirox

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