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Last Updated: January 25, 2020

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JADENU Drug Profile

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When do Jadenu patents expire, and when can generic versions of Jadenu launch?

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

This drug has one hundred and five patent family members in fifty countries.

The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Twelve 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 25th, 2020.

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Drug patent expirations by year for JADENU
Drug Prices for JADENU

See drug prices for JADENU

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

Recent Litigation for JADENU

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 JADENU litigation

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 RX Yes 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
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 RX Yes No   Start Trial   Start Trial Y Y   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 206910-003 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 206910-001 Mar 30, 2015   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 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 SPC 035/2006 Ireland   Start Trial SPC 035/2006: 20070528, EXPIRES: 20210827
0914118 300248 Netherlands   Start Trial 300248, 20170624, EXPIRES: 20210827
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Dow
Mallinckrodt
Harvard Business School

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