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Last Updated: December 7, 2022

Deferasirox - Generic Drug Details


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What are the generic drug sources for deferasirox and what is the scope of patent protection?

Deferasirox is the generic ingredient in four branded drugs marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Teva Pharms Usa, Novartis, Actavis Elizabeth, Alembic Pharms Ltd, Bionpharma Inc, Ichnos, Sun Pharm, Zydus Pharms, Celltrion, Piramal Hlthcare Uk, and Novartis Pharms Corp, and is included in thirty-one NDAs. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty drug master file entries for deferasirox. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for deferasirox

See drug prices for deferasirox

Recent Clinical Trials for deferasirox

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

SponsorPhase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 2
EmeraMedPhase 2
DisperSol Technologies, LLCPhase 2

See all deferasirox clinical trials

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing500MGTABLET, FOR SUSPENSION;ORAL
See Plans and PricingSee Plans and Pricing250MGTABLET, FOR SUSPENSION;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Zydus Pharms DEFERASIROX deferasirox TABLET;ORAL 211383-003 Jun 15, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cipla DEFERASIROX deferasirox TABLET;ORAL 211852-001 Feb 11, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 208882-002 May 5, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 208882-003 May 5, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zydus Pharms DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 208882-001 May 5, 2020 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 See Plans and Pricing See Plans and Pricing
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 See Plans and Pricing See Plans and Pricing
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 See Plans and Pricing See Plans and Pricing
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

International Patents for deferasirox

Country Patent Number Title Estimated Expiration
Nicaragua 201500126 FORMULACIONES ORALES DE DEFERASIROX See Plans and Pricing
New Zealand 711179 Oral formulations of deferasirox See Plans and Pricing
Malaysia 170303 ORAL FORMULATIONS OF DEFERASIROX See Plans and Pricing
Peru 20151600 FORMULACIONES ORALES DE DEFERASIROX See Plans and Pricing
South Korea 101925671 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for deferasirox

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 PA2007001 Lithuania See Plans and Pricing PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828
0914118 SPC/GB07/002 United Kingdom See Plans and Pricing 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.
0914118 C00914118/01 Switzerland See Plans and Pricing PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118 06C0049 France See Plans and Pricing PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
0914118 PA2007001,C0914118 Lithuania See Plans and Pricing PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
>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.