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Last Updated: November 26, 2020

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JADENU Drug Profile

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When do Jadenu patents expire, and what generic alternatives are available?

Jadenu is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has sixty-two patent family members in thirty-eight countries.

The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

US ANDA Litigation and Generic Entry Outlook for Jadenu

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

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Drug patent expirations by year for JADENU
Drug Prices for JADENU

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Recent Clinical Trials for JADENU

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

SponsorPhase
DisperSol Technologies, LLCPhase 2
Novartis PharmaceuticalsPhase 2

See all JADENU clinical trials

Paragraph IV (Patent) Challenges for JADENU
Tradename Dosage Ingredient NDA Submissiondate
JADENU TABLET;ORAL deferasirox 206910 2016-04-21
JADENU TABLET;ORAL deferasirox 206910 2015-10-19

US Patents and Regulatory Information for JADENU

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 206910-001 Mar 30, 2015 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 AB 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 JADENU

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 Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for JADENU

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SPC 035/2006 Ireland   Start Trial SPC 035/2006: 20070528, EXPIRES: 20210827
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/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.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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