JADENU SPRINKLE Drug Patent Profile

When do Jadenu Sprinkle patents expire, and when can generic versions of Jadenu Sprinkle launch?

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jadenu Sprinkle

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

Summary for JADENU SPRINKLE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	142
Patent Applications:	1,373
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for JADENU SPRINKLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JADENU SPRINKLE
DailyMed Link:	JADENU SPRINKLE at DailyMed

See drug prices for JADENU SPRINKLE

Pharmacology for JADENU SPRINKLE

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 JADENU SPRINKLE

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

US Patents and Regulatory Information for JADENU SPRINKLE

JADENU SPRINKLE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting JADENU SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017	AB	RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017	AB	RX	Yes	No
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-003	May 18, 2017	AB	RX	Yes	Yes

Expired US Patents for JADENU SPRINKLE

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	207968-003	May 18, 2017
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-002	May 18, 2017

EU/EMA Drug Approvals for JADENU SPRINKLE

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 JADENU SPRINKLE

See the table below for patents covering JADENU SPRINKLE around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	9903111
World Intellectual Property Organization (WIPO)	9749395
Australia	3262997
Japan	2000507601
Germany	122007000020
Czech Republic	291470	Substituované 3,5-difenyl-1,2,4-triazoly, jejich použití jako léčiv chelatujících kovy a způsob jejich přípravy (Substituted 3,5-diphenyl-1,2,4-triazoles, their use as iron chelating medicaments and process of their preparation)

Supplementary Protection Certificates for JADENU SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0914118	SPC 035/2006	Ireland		SPC 035/2006: 20070528, EXPIRES: 20210827
0914118	300248	Netherlands		300248, 20170624, EXPIRES: 20210827
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	290	Finland
0914118	CA 2006 00035	Denmark
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