EXJADE Drug Patent Profile

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. Nineteen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

DrugPatentWatch^® 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	141
Clinical Trials:	36
Patent Applications:	1,584
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EXJADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EXJADE
What excipients (inactive ingredients) are in EXJADE?	EXJADE excipients list
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2
DisperSol Technologies, LLC	Phase 2
Fondazione Italiana Sindromi Mielodisplastiche-ETS	Phase 2

See all EXJADE clinical trials

Pharmacology for EXJADE

Drug Class	Iron Chelator
Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for EXJADE

V03AC	Iron chelating agents
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for EXJADE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EXJADE	Tablets for Suspension	deferasirox	125 mg, 250 mg, and 500 mg	021882	1	2011-10-28

US Patents and Regulatory Information for EXJADE

EXJADE is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting 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	021882-002	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
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	AB	RX	Yes	Yes
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	AB	RX	Yes	Yes

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	021882-003	Nov 2, 2005
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005

EU/EMA Drug Approvals for EXJADE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Deferasirox Mylan	deferasirox	EMEA/H/C/005014 Deferasirox Mylan is indicated forthe treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and olderthe treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2019-09-26
Novartis Europharm Limited	Exjade	deferasirox	EMEA/H/C/000670 Exjade is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged six years and older.Exjade is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥ 7 ml/kg/month of packed red blood cells) aged two to five years;in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (< 7 ml/kg/month of packed red blood cells) aged two years and older;in patients with other anaemias aged two years and older.Exjade is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.	Authorised	no	no	no	2006-08-28
Accord Healthcare S.L.U.	Deferasirox Accord	deferasirox	EMEA/H/C/005156 Deferasirox Accord is indicated for the treatment of chronic iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older.Deferasirox Accord is also indicated for the treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in the following patient groups:in paediatric patients with beta thalassaemia major with iron overload due to frequent blood transfusions (≥7 ml/kg/month of packed red blood cells) aged 2 to 5 years,in adult and paediatric patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (	Authorised	yes	no	no	2020-01-09

International Patents for EXJADE

See the table below for patents covering EXJADE around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	127212
South Korea	20050098029
China	1146415
New Zealand	333308	Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators
Germany	122007000020
Austria	226435

Supplementary Protection Certificates for EXJADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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.
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	300248	Netherlands		300248, 20170624, EXPIRES: 20210827
0914118	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118	290	Finland