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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 Novartis and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has sixty-two patent family members in thirty-eight countries.

The generic ingredient in JADENU 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 Jadenu

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

Summary for JADENU

International Patents:	62
US Patents:	1
Applicants:	2
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	108
Clinical Trials:	2
Patent Applications:	546
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

See drug prices for JADENU

Recent Clinical Trials for JADENU

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

Sponsor	Phase
DisperSol Technologies, LLC	Phase 2
Novartis Pharmaceuticals	Phase 2

See all JADENU clinical trials

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

Paragraph IV (Patent) Challenges for JADENU

Tradename	Dosage	Ingredient	NDA	Submissiondate
JADENU	TABLET;ORAL	deferasirox	206910	2016-04-21
JADENU	TABLET;ORAL	deferasirox	206910	2015-10-19

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	AB	RX	Yes	No			Y	Y
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	AB	RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017	AB	RX	Yes	Yes
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	AB	RX	Yes	No
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	AB	RX	Yes	No

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

International Patents for JADENU

Country	Patent Number	Estimated Expiration
Argentina	095058
Cuba	20150110
South Korea	101925671
Hungary	226232
Slovenia	3124018

Supplementary Protection Certificates for JADENU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
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/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.