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EXJADE Drug Profile

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Which patents cover Exjade, and what substitute generic drugs are available?

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-six patent family members in thirty-four countries.

The generic ingredient in EXJADE is deferasirox. There are eighteen 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

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list61
Clinical Trials: see list11
Patent Applications: see list268
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EXJADE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005RXYesNo6,596,750► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005RXYesYes6,596,750► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005RXYesNo6,596,750► SubscribeY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005RXYesYes6,465,504► SubscribeYY ► Subscribe
Novartis
EXJADE
deferasirox
TABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005RXYesNo6,465,504► SubscribeYY ► Subscribe
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Paragraph IV activity 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
Malaysia129541► Subscribe
Bulgaria103003► Subscribe
Japan2000507601► Subscribe
Slovakia178598► Subscribe
South Korea20000022222► 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
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
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.
0248Netherlands► Subscribe300248, 20170624, EXPIRES: 20210827
2006 00035Denmark► Subscribe
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