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Last Updated: February 25, 2020

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DEFERASIROX - Generic Drug Details

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What are the generic drug 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, Alembic Pharms Ltd, Alkem Labs Ltd, Bionpharma Inc, Ichnos, MSN, Sun Pharm, Amneal Pharms Co, Piramal Hlthcare Uk, Teva Pharms Usa, Zydus Pharms, and Novartis Pharms Corp, and is included in eighteen 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 five patent family members in fifty countries.

There are twenty drug master file entries for deferasirox. Fifteen suppliers are listed for this compound. There are eight 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
National Cancer Institute (NCI)Phase 2

See all DEFERASIROX clinical trials

Recent Litigation for DEFERASIROX

Identify potential future generic entrants

District Court Litigation
Case NameDate
ALEMBIC PHARMACEUTICALS, LTD v. NOVARTIS PHARMACEUTICALS CORP.2019-11-27
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2016-07-29
Novartis Pharmaceuticals Corporation v. Mylan Inc.2014-06-26

See all DEFERASIROX litigation

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial180MGTABLET; ORAL
  Start Trial  Start Trial360MGTABLET;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 Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Actavis Elizabeth DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 203560-002 Jan 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ichnos DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 209433-003 Jan 6, 2020 AB RX No 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 EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017   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
>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 SPC/GB07/002 United Kingdom   Start 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.
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
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Harvard Business School
Moodys
Colorcon

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