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EXJADE

NDA

DEFERASIROX | N021882 | NOVARTIS PHARMACEUTICALS CORP

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

81 trials from ClinicalTrials.gov, 54 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload NCT00481143	Phase 4	Completed	Novartis Pharmaceuticals	63	2007-05
Effect of Deferasirox on Patients With Cardiac MRI T2* < 20 Msec NCT00879242	Phase 2	Completed	Novartis Pharmaceuticals	20	2009-02
Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis NCT00395629	Phase 1/2	Completed	Novartis Pharmaceuticals	49	2006-08 → 2009-03
Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam NCT00427505	Phase 1	Completed	Novartis	22	2006-07
Combination Deferasirox and Deferiprone for Severe Iron Overload in Thalassemia NCT01709032	Phase 1/2	Completed	Children's Hospital of Philadelphia	9	2012-09 → 2017-08-01
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation NCT02720536	Phase 3	Completed	Novartis Pharmaceuticals	53	2016-08-16 → 2019-07-23
This Study Will Evaluate Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndromes (MDS), Thalassemia and Rare Anemia Types Having Transfusion-induced Iron Overload.NCT01250951	Phase 4	Completed	Novartis Pharmaceuticals	111	2009-12 → 2011-09
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload NCT00560820	Phase 1	Completed	Novartis Pharmaceuticals	11	2007-09 → 2012-04
Efficacy and Safety of Desferal Versus Osveral in Transfusional Iron Overload NCT01369719	N/A	Completed	Hormozgan University of Medical Sciences	138	2010-02 → 2011-05
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload NCT02435212	Phase 2	Completed	Novartis Pharmaceuticals	224	2015-10-21 → 2024-01-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$1164.27

Highest Price

$5735.13

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00078-0468-15EXJADE 125MG TAB	$1433.83	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0468-15EXJADE 125MG TAB	$1164.27	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0469-15EXJADE 250MG TAB	$2867.63	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0469-15EXJADE 250MG TAB	$2315.38	Big4	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0470-15EXJADE 500MG TAB	$5735.13	FSS	Novartis Pharmaceuticals Corporation	08/31/2026
00078-0470-15EXJADE 500MG TAB	$4629.33	Big4	Novartis Pharmaceuticals Corporation	08/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Exjade (2024)

Total Spending

$3.2M

Total Claims

232

Beneficiaries

Avg Cost/Unit

$159.61

Spending Trend

$37.9M(2019)→$14.7M(2020)→$8.6M(2021)→$4.2M(2022)→$2.9M(2023)→$3.2M(2024)

YoY Change:+1.6%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain22 active DMFs5 inactive

21 active API suppliers hold Drug Master Files for this ingredient.

MATRIX PHARMACORP PRIVATE LTDDEFERASIROX

DMF 223692008

ALIVUS LIFE SCIENCES LTDDEFERASIROX

DMF 242092010

NEULAND LABORATORIES LTDDEFERASIROX

DMF 257332012

MSN LABORATORIES PRIVATE LTDDEFERASIROX [ROUTE CODE - "DR"]

DMF 258372012

JUBILANT BIOSYS LTDDEFERASIROX

DMF 258882012

PURE AND CURE HEALTHCARE PRIVATE LTDDEFERASIROX

DMF 259642012

ALEMBIC PHARMACEUTICALS LTDDEFERASIROX

DMF 268332013

TAPI NL BVDEFERASIROX

DMF 276482014

BIOCON LTDDEFERASIROX

DMF 286262015

SUN PHARMACEUTICAL INDUSTRIES LTDDEFERASIROX

DMF 293202015

TAPI NL BVDEFERASIROX

DMF 295482015

MEDILUX LABORATORIES PVT LTDDEFERASIROX

DMF 306952016

CIPLA LTDDEFERASIROX

DMF 308172016

PIRAMAL PHARMA LTDDEFERASIROX

DMF 314852017

YUNG ZIP CHEMICAL IND CO LTDDEFERASIROX

DMF 315992017

SYMED LABS LTDDEFERASIROX

DMF 318772019

APITORIA PHARMA PRIVATE LTDDEFERASIROX

DMF 341912019

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DEFERASIROX

DMF 356512021

CTX LIFESCIENCES PVT LTDDEFERASIROX

DMF 389632023

ZHEJIANG HENGKANG PHARMACEUTICAL CO LTDDEFERASIROX

DMF 410512024

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDDEFERASIROX

DMF 412022025

SMS PHARMACEUTICALS LTDDEFERASIROX

DMF 419172025

BACHEM SAInactiveDEFERASIROX

DMF 260032012

ERREGIERRE SPAInactiveDEFERASIROX

DMF 264682012

APOTEX PHARMACHEM INDIA PVT LTDInactiveDEFERASIROX

DMF 283792014

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveDEFERASIROX

DMF 288052014

CTX LIFE SCIENCES PVT LTDInactiveDEFERASIROX

DMF 302132016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -37	View Letter (PDF)
Jul 27, 2020	SUPPL -33	View Letter (PDF)
Jul 24, 2020	SUPPL -33	View Letter (PDF)
Jul 29, 2019	SUPPL -30	View Letter (PDF)
Jun 4, 2019	SUPPL -31	View Letter (PDF)
Dec 20, 2018	SUPPL -29	View Letter (PDF)
Dec 20, 2018	SUPPL -28	View Letter (PDF)
May 15, 2018	SUPPL -25	View Letter (PDF)
Feb 23, 2018	SUPPL -26	View Letter (PDF)
Aug 17, 2016	SUPPL -24	View Letter (PDF)
Jul 24, 2015	SUPPL -21	View Letter (PDF)
Oct 22, 2013	SUPPL -19	View Letter (PDF)
May 31, 2013	SUPPL -17	View Letter (PDF)
Jan 25, 2013	SUPPL -15	View Letter (PDF)
Jan 25, 2013	SUPPL -16	View Letter (PDF)
Sep 18, 2012	SUPPL -14	View Letter (PDF)
Aug 12, 2011	SUPPL -12	View Letter (PDF)
Apr 13, 2011	SUPPL -11	View Letter (PDF)
Feb 5, 2010	SUPPL -10	View Letter (PDF)
Apr 27, 2009	SUPPL -6	View Letter (PDF)
Mar 10, 2009	SUPPL -7	View Letter (PDF)
Oct 8, 2008	SUPPL -4	View Letter (PDF)
Jan 9, 2008	SUPPL -3	View Letter (PDF)
May 1, 2007	SUPPL -2	View Letter (PDF)
Nov 8, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 125MG

RLDAB

0 patents0 exclusivities▴

TABLET, FOR SUSPENSION;ORAL | Approved: Nov 2, 2005

No patent or exclusivity listings for this strength.

#002 — 250MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Nov 2, 2005

#003 — 500MG

RLDAB

0 patents0 exclusivities▾

TABLET, FOR SUSPENSION;ORAL | Approved: Nov 2, 2005