Deferasirox

Treats chronic iron overload due to blood transfusions. Sold as Exjade, Jadenu, Jadenu Sprinkle. Every FDA application for this active ingredient: 3 branded and 35 generic.

As of Nov 15, 2026, FDA lists 38 applications for Deferasirox (sold as Exjade, Jadenu, Jadenu Sprinkle), first approved Nov 2, 2005, with 16 new uses approved and 0 published complete response letters.

First approved: Nov 2, 2005
Applications: 38
New uses approved: 16
Complete response letters: 0
Medicare spending, 2025: $39.1M
First approved in the EU: Aug 28, 2006
First approved in Japan: Apr 16, 2008

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Deferasirox	Part D	$30.0M	+2%	4,090
Jadenu	Part D	$6.7M	-13%	72
Exjade	Part D	$2.2M	-30%	35
Jadenu Sprinkle	Part D	$109K	+24%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DEFERASIROX 360 MG TABLET: $1.12 per unitGeneric · -12% in a year
DEFERASIROX 500 MG TB FOR SUSP: $5.85 per unitGeneric · new this year

Orphan Designations (FDA)

4 designations, 4 approved for the designated use; see all orphan designations

Treatment of chronic iron overload in alpha-thalassemiaNovartis Pharmaceuticals Corporation · designated Feb 24, 2015 · approved May 18, 2017
Treatment of chronic iron overload in alpha-thalassemiaNovartis Pharmaceuticals Corporation · designated Feb 24, 2015 · approved Jan 23, 2013
Treatment of chronic iron overload in patients with transfusion-dependent anemiasNovartis Pharmaceuticals Corp. · designated Nov 21, 2002 · approved May 18, 2017
Treatment of chronic iron overload in patients with transfusion-dependent anemiasNovartis Pharmaceuticals Corp. · designated Nov 21, 2002 · approved Nov 2, 2005

Approvals in the EU (EMA)

First approved in the EU 10 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Deferasirox Accord, genericAccord Healthcare S.L.U. · Jan 9, 2020
Deferasirox Mylan, genericMylan Pharmaceuticals Limited · Sep 26, 2019
Exjade, new substanceNovartis Europharm Limited · Aug 28, 2006

Approvals in Japan (PMDA)

First approved in Japan 29 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Jadenu, new approvalDrugs in a new dosage form indicated for the treatment of chronic iron overload due to blood transfusions (in patients for whom injection of iron chelating… · Novartis Pharma K.K. · Jul 3, 2017
Exjade Dispersible, new ingredientDrugs with a new active ingredient indicated for the treatment of chronic iron overload due to blood transfusions (in patients for whom injection of iron… · Novartis Pharma K.K. · Apr 16, 2008

Clinical Trials

5 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Evaluation of the Quality of Life in Patients With Chronic Iron Overload Due to Hemoglobinopathies in Greece.Thalassemia, Iron Overload · Elpen Pharmaceutical Co. Inc.	—	Not yet recruiting	Jan 20, 2026
Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta ThalassemiaBeta Thalassemia · Tanta University	Phase 3	Not yet recruiting	Sep 5, 2025
Early Screening and Treatment of Heart Complication in Sickle Cell DiseaseSickle Cell Disease · Inova Health Care Services	Phase 2	Recruiting	Jun 17, 2025
Treatment of Transfusion-dependent Nonsevere Aplastic Anemia With Luspatercept: a Multicenter Prospective Clinical StudyTransfusion-dependent Non-severe Aplastic Anemia · The First Affiliated Hospital of Zhejiang Chinese Medical University	Not applicable	Not yet recruiting	May 11, 2025
Phase II Study of Resistant Potato Starch Plus Deferasirox to Improve Outcomes in Patients Undergoing Allogeneic Stem Cell TransplantationAllogeneic Stem Cell Transplant · University of Michigan Rogel Cancer Center	Phase 2	Recruiting	Jan 20, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 2, 2005	ExjadeNDA 21882 · New molecular entity	Novartis	24	Marketed
Mar 30, 2015	JadenuNDA 206910 · New formulation or manufacturer	Novartis Pharms Corp	14	Marketed
Jan 26, 2016	DeferasiroxANDA 203560	Actavis Elizabeth	6	Marketed
May 18, 2017	Jadenu SprinkleNDA 207968 · New formulation or manufacturer	Novartis	8	Marketed
Nov 20, 2019	DeferasiroxANDA 210060	Alembic	0	Marketed
Nov 20, 2019	DeferasiroxANDA 210519	Alkem Labs Ltd	1	Marketed
Nov 20, 2019	DeferasiroxANDA 209782	Sun Pharm	7	Marketed
Nov 20, 2019	DeferasiroxANDA 209878	Msn	2	Marketed
Nov 20, 2019	DeferasiroxANDA 210920	Bionpharma	2	Marketed
Dec 13, 2019	DeferasiroxANDA 208697	Actavis Elizabeth	2	Marketed
Jan 3, 2020	DeferasiroxANDA 209433	Glenmark Speclt	2	Marketed
Apr 24, 2020	DeferasiroxANDA 209223	Teva Pharms USA	0	Discontinued
May 5, 2020	DeferasiroxANDA 208882	Zydus Pharms	0	Discontinued
Jun 15, 2020	DeferasiroxANDA 210727	Stevens J	1	Discontinued
Jun 15, 2020	DeferasiroxANDA 211641	Sun Pharm	2	Discontinued
Jun 15, 2020	DeferasiroxANDA 211824	Alembic	2	Marketed
Jun 15, 2020	DeferasiroxANDA 211852	Cipla	0	Discontinued
Jun 15, 2020	DeferasiroxANDA 212995	Piramal	2	Marketed
Jun 15, 2020	DeferasiroxANDA 211383	Zydus Pharms	5	Marketed
Jun 16, 2020	DeferasiroxANDA 210945	Msn	4	Marketed
Jul 2, 2020	DeferasiroxANDA 210555	Alkem Labs Ltd	1	Marketed
Jul 14, 2020	DeferasiroxANDA 213374	Alkem Labs Ltd	1	Marketed
Feb 9, 2021	DeferasiroxANDA 214194	Amneal	1	Discontinued
Mar 9, 2021	DeferasiroxANDA 214559	Pharmazone	1	Marketed
Mar 17, 2021	DeferasiroxANDA 214650	Msn	1	Marketed
May 14, 2021	DeferasiroxANDA 214341	Annora Pharma	1	Marketed
May 27, 2021	DeferasiroxANDA 212669	Chartwell Rx	0	Marketed
Nov 19, 2021	DeferasiroxANDA 214180	Teva Pharms USA	3	Discontinued
Feb 23, 2022	DeferasiroxANDA 215026	Cipla	0	Marketed
Sep 22, 2022	DeferasiroxANDA 216229	Annora Pharma	2	Marketed
Sep 23, 2022	DeferasiroxANDA 207124	Teva Pharms USA	0	Marketed
Oct 16, 2023	DeferasiroxANDA 214474	Aurobindo Pharma Ltd	0	Marketed
Mar 22, 2024	DeferasiroxANDA 211395	Pharmobedient	0	Marketed
May 3, 2024	DeferasiroxANDA 213146	Pharmobedient	0	Discontinued
May 17, 2024	DeferasiroxANDA 206585	Pharmobedient	0	Discontinued
Nov 5, 2024	DeferasiroxANDA 209426	Torrent	0	Discontinued
Apr 11, 2025	DeferasiroxANDA 211660	Jubilant Generics	0	Marketed
Sep 8, 2025	DeferasiroxANDA 215137	Aurobindo Pharma	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA