DEFERASIROX Drug Patent Profile

Which patents cover Deferasirox, and what generic alternatives are available?

Deferasirox is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Ichnos, Sun Pharm, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal Hlthcare Uk, and Stevens J. and is included in twenty-nine NDAs.

The generic ingredient in DEFERASIROX 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 Deferasirox

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

Summary for DEFERASIROX

US Patents:	0
Applicants:	17
NDAs:	29
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	95
Patent Applications:	1,373
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DEFERASIROX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEFERASIROX
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
EmeraMed	Phase 2
DisperSol Technologies, LLC	Phase 2

See all DEFERASIROX clinical trials

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
Msn	DEFERASIROX	deferasirox	TABLET;ORAL	210945-002	Nov 20, 2019	AB	RX	No	No
Sun Pharm	DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	209782-002	Nov 20, 2019	AB	RX	No	No
Bionpharma	DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	210920-002	Nov 20, 2019	AB	RX	No	No
Zydus Pharms	DEFERASIROX	deferasirox	TABLET;ORAL	211383-003	Jun 15, 2020	AB	RX	No	No
Actavis Elizabeth	DEFERASIROX	deferasirox	TABLET;ORAL	208697-001	Dec 13, 2019	AB	RX	No	No
Annora Pharma	DEFERASIROX	deferasirox	TABLET;ORAL	214341-003	May 14, 2021	AB	RX	No	No
Teva Pharms Usa	DEFERASIROX	deferasirox	TABLET, FOR SUSPENSION;ORAL	207124-003	Sep 23, 2022		DISCN	No	No

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