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Last Updated: November 18, 2019

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Deferasirox - Generic Drug Details

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What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Novartis, Actavis Elizabeth, and Novartis Pharms Corp, and is included in four NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has one hundred and four patent family members in fifty countries.

There are twenty drug master file entries for deferasirox. Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for deferasirox

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SponsorPhase
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2
DisperSol Technologies, LLCPhase 2
Fred Hutchinson Cancer Research CenterPhase 2

See all deferasirox clinical trials

Recent Litigation for deferasirox

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2016-07-29
Novartis Pharmaceuticals Corporation v. Mylan Inc.2014-06-26
Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc.2014-06-25

See all deferasirox litigation

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial360MGTABLET;ORAL
  Start Trial  Start Trial180MGTABLET;ORAL
  Start Trial  Start Trial90MGTABLET;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 NDA Submissiondate
JADENU TABLET;ORAL deferasirox 206910 2016-04-21
JADENU TABLET;ORAL deferasirox 206910 2015-10-19
EXJADE TABLET, FOR SUSPENSION;ORAL deferasirox 021882 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
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 RX Yes No   Start Trial   Start Trial   Start 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 deferasirox

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

Supplementary Protection Certificates for deferasirox

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 PA2007001 Lithuania   Start Trial 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 C00914118/01 Switzerland   Start Trial PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0914118 CA 2006 00035 Denmark   Start Trial
0914118 PA2007001,C0914118 Lithuania   Start Trial 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 290 Finland   Start Trial
0914118 06C0049 France   Start Trial 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 SPC 035/2006 Ireland   Start Trial SPC 035/2006: 20070528, EXPIRES: 20210827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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