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Last Updated: April 22, 2024

JADENU Drug Patent Profile


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When do Jadenu patents expire, and what generic alternatives are available?

Jadenu is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has sixty-seven patent family members in forty-two countries.

The generic ingredient in JADENU 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 Jadenu

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

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Drug patent expirations by year for JADENU
Drug Prices for JADENU

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Recent Clinical Trials for JADENU

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

SponsorPhase
DisperSol Technologies, LLCPhase 2
Novartis PharmaceuticalsPhase 2

See all JADENU clinical trials

Paragraph IV (Patent) Challenges for JADENU
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

US Patents and Regulatory Information for JADENU

JADENU is protected by one US patents.

Patents protecting JADENU

Oral formulations of deferasirox
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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 JADENU

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for JADENU

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

Supplementary Protection Certificates for JADENU

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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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