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Last Updated: July 13, 2024

DEFERASIROX Drug Patent Profile


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

Deferasirox is a drug marketed by Alkem Labs Ltd, Amneal, Annora Pharma, Aucta, Cipla, MSN, Mylan, Teva Pharms Usa, Actavis Elizabeth, Alembic, Bionpharma, Ichnos, Sun Pharm, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Piramal Hlthcare Uk, and Stevens J. and is included in thirty-one NDAs.

The generic ingredient in DEFERASIROX 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 Deferasirox

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

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Drug patent expirations by year for DEFERASIROX
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Recent Clinical Trials for DEFERASIROX

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SponsorPhase
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 2
Children's Hospital KarachiPhase 2/Phase 3
EmeraMedPhase 2

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Anatomical Therapeutic Chemical (ATC) Classes for DEFERASIROX
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
Cipla DEFERASIROX deferasirox TABLET;ORAL 211852-002 Feb 11, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 209878-002 Nov 20, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alkem Labs Ltd DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 210519-002 Nov 20, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm DEFERASIROX deferasirox TABLET;ORAL 211641-003 Jun 15, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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

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