DEFERASIROX - Generic Drug Details

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

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Norvium Bioscience, Teva Pharms Usa, Novartis, Actavis Elizabeth, Alembic, Bionpharma, Glenmark Speclt, Sun Pharm, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal, Stevens J, and Novartis Pharms Corp, and is included in thirty-five 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-seven patent family members in forty-two countries.

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

Summary for DEFERASIROX

International Patents:	67
US Patents:	1
Tradenames:	4
Applicants:	20
NDAs:	35
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	96
Patent Applications:	2,045
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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2
Children's Hospital Karachi	Phase 2/Phase 3
EmeraMed	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	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for DEFERASIROX

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

Paragraph IV (Patent) Challenges for DEFERASIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JADENU	Tablets	deferasirox	180 mg	206910	1	2016-04-21
JADENU	Tablets	deferasirox	90 mg and 360 mg	206910	1	2015-10-19
EXJADE	Tablets for Suspension	deferasirox	125 mg, 250 mg, and 500 mg	021882	1	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
Aucta	DEFERASIROX	deferasirox	GRANULE;ORAL	214559-001	Mar 9, 2021	AB	RX	No	No
Chartwell Rx	DEFERASIROX	deferasirox	TABLET;ORAL	212669-001	May 27, 2021	AB	RX	No	No
Msn	DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	209878-001	Nov 20, 2019	AB	RX	No	No

Expired US Patents for DEFERASIROX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015
Novartis	JADENU SPRINKLE	deferasirox	GRANULE;ORAL	207968-001	May 18, 2017

EU/EMA Drug Approvals for DEFERASIROX

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 DEFERASIROX

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014136079
South Korea	101925671
Japan	6739470

Supplementary Protection Certificates for DEFERASIROX

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	C00914118/01	Switzerland		PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
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