DrugPatentWatch Database Preview

Deferasirox - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for deferasirox and what is the scope of patent protection?

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Novartis, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Ichnos, MSN, Sun Pharm, Zydus Pharms, Amneal, Cipla, Piramal Hlthcare Uk, Teva Pharms Usa, and Novartis Pharms Corp, and is included in twenty-two NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has sixty-three patent family members in thirty-eight countries.

There are twenty drug master file entries for deferasirox. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for deferasirox

International Patents:	63
US Patents:	1
Tradenames:	4
Applicants:	14
NDAs:	22
Drug Master File Entries:	20
Suppliers / Packagers:	17
Bulk Api Vendors:	112
Clinical Trials:	87
Patent Applications:	1,944
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for deferasirox
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deferasirox
What excipients (inactive ingredients) are in deferasirox?	deferasirox excipients list
DailyMed Link:	deferasirox at DailyMed

See drug prices for deferasirox

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

Generic filers with tentative approvals for DEFERASIROX

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET, FOR SUSPENSION;ORAL
		250MG	TABLET, FOR SUSPENSION;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 Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	AB	RX	Yes	No
Zydus Pharms	DEFERASIROX	deferasirox	TABLET;ORAL	211383-001	Nov 20, 2019	AB	RX	No	No
Bionpharma Inc	DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	210920-001	Nov 20, 2019	AB	RX	No	No
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	AB	RX	Yes	No

Expired US Patents for deferasirox

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	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015

International Patents for deferasirox

Country	Patent Number	Estimated Expiration
European Patent Office	2964202
Japan	6434429
World Intellectual Property Organization (WIPO)	2014136079
Eurasian Patent Organization	031719

Supplementary Protection Certificates for deferasirox

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
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	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