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Generated: October 23, 2017

DrugPatentWatch Database Preview

EXJADE Drug Profile

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What is the patent landscape for Exjade, and when can generic versions of Exjade launch?

Exjade is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-eight patent family members in thirty-four countries and nine supplementary protection certificates in eight countries.

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

Summary for Tradename: EXJADE

US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list61
Clinical Trials: see list27
Patent Applications: see list316
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EXJADE at DailyMed
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;ORAL021882-001Nov 2, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: EXJADE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005► Subscribe► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005► Subscribe► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for EXJADE

Drugname Dosage Strength RLD Submissiondate
deferasiroxTablets125 mg, 250 mg, and 500 mgExjade10/28/2011

Non-Orange Book Patents for Tradename: EXJADE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,723,742 Substituted 3,5-diphenyl-1,2,4-triazoles and their use as pharmaceutical metal chelators► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: EXJADE

Country Document Number Estimated Expiration
South Korea20050098029► Subscribe
Israel127212► Subscribe
Poland194758► Subscribe
Slovakia178598► Subscribe
Germany69716602► Subscribe
African Regional IP Organization (ARIPO)9801407► Subscribe
Cyprus2429► Subscribe
South Korea100616378► Subscribe
Brazil9709973► Subscribe
Czech Republic291470► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EXJADE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007001,C0914118Lithuania► SubscribePRODUCT 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
2006 00035Denmark► Subscribe
C/GB07/002United Kingdom► SubscribeSUPPLEMENTARY 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.
C 035/2006Ireland► SubscribeSPC 035/2006: 20070528, EXPIRES: 20210827
C0049France► SubscribePRODUCT 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
2007001Lithuania► SubscribePRODUCT 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
0914118/01Switzerland► SubscribePRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
0Finland► Subscribe
0248Netherlands► Subscribe300248, 20170624, EXPIRES: 20210827
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Citi
Boehringer Ingelheim
Chubb
Mallinckrodt
Fuji
Cantor Fitzgerald
US Army
Cipla
Deloitte
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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