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Last Updated: April 22, 2024

EXJADE Drug Patent Profile


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

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

The generic ingredient in EXJADE 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 Exjade

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

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Drug patent expirations by year for EXJADE
Drug Prices for EXJADE

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Recent Clinical Trials for EXJADE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 2
DisperSol Technologies, LLCPhase 2
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2

See all EXJADE clinical trials

Paragraph IV (Patent) Challenges for EXJADE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXJADE Tablets for Suspension deferasirox 125 mg, 250 mg, and 500 mg 021882 1 2011-10-28

US Patents and Regulatory Information for EXJADE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EXJADE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for EXJADE

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EXJADE

See the table below for patents covering EXJADE around the world.

Country Patent Number Title Estimated Expiration
Norway 986024 ⤷  Try a Trial
Hungary 226232 SUBSTITUTED 3,5-DIPHENYL-1,2,4-TRIAZOLES, THEIR PRODUCTION PROCESSES, THEIR USE AS PHARMACEUTICAL METAL CHELATORS AND PHARAMCEUTICAL COMPOSITIONS COMPRISING SAID COMPOSITIONS ⤷  Try a Trial
Poland 194758 ⤷  Try a Trial
Brazil 9709973 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EXJADE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 290 Finland ⤷  Try a Trial
0914118 300248 Netherlands ⤷  Try a Trial 300248, 20170624, EXPIRES: 20210827
0914118 SPC 035/2006 Ireland ⤷  Try a Trial SPC 035/2006: 20070528, EXPIRES: 20210827
0914118 SPC/GB07/002 United Kingdom ⤷  Try a Trial 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.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.