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Last Updated: August 12, 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, Zydus Pharms, Amneal, Cipla, Piramal Hlthcare Uk, Teva Pharms Usa, and Novartis Pharms Corp, and is included in twenty-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 patent family members in thirty-eight countries.

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

Drug Prices for DEFERASIROX

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Recent Clinical Trials for DEFERASIROX

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

SponsorPhase
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2
DisperSol Technologies, LLCPhase 2
National Cancer Institute (NCI)Phase 2

See all DEFERASIROX clinical trials

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGTABLET, FOR SUSPENSION;ORAL
  Start Trial  Start Trial250MGTABLET, 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 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
Msn DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 209878-001 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd DEFERASIROX deferasirox TABLET;ORAL 211824-002 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Bionpharma Inc DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 210920-002 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Msn DEFERASIROX deferasirox TABLET;ORAL 210945-001 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm DEFERASIROX deferasirox TABLET;ORAL 211641-001 Jan 2, 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 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 EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005   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 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 C00914118/01 Switzerland   Start Trial PRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
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 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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