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Generated: December 12, 2017

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Deferasirox - Generic Drug Details

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What are the generic sources for deferasirox and what is the scope of deferasirox freedom to operate?

Deferasirox
is the generic ingredient in four branded drugs marketed by Novartis Pharms Corp, Actavis Elizabeth, and Novartis, and is included in four NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has seventy-four patent family members in forty-six countries and nine supplementary protection certificates in eight countries.

There are twenty drug master file entries for deferasirox. One supplier is listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Actavis ElizabethDEFERASIROXdeferasiroxTABLET, FOR SUSPENSION;ORAL203560-003Jan 26, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-002Mar 30, 2015RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpJADENU SPRINKLEdeferasiroxGRANULE;ORAL207968-002May 18, 2017RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-003Mar 30, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpJADENU SPRINKLEdeferasiroxGRANULE;ORAL207968-003May 18, 2017RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-002Mar 30, 2015RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-003Mar 30, 2015RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-003Nov 2, 2005► Subscribe► Subscribe
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-001Nov 2, 2005► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-003Mar 30, 2015► Subscribe► Subscribe
NovartisEXJADEdeferasiroxTABLET, FOR SUSPENSION;ORAL021882-002Nov 2, 2005► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-001Mar 30, 2015► Subscribe► Subscribe
Novartis Pharms CorpJADENUdeferasiroxTABLET;ORAL206910-002Mar 30, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: deferasirox

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 Ingredient: deferasirox

Country Document Number Estimated Expiration
Uruguay35367► Subscribe
Slovenia914118► Subscribe
Tunisia2015000393► Subscribe
Australia718037► Subscribe
Dominican RepublicP2015000220► Subscribe
African Intellectual Property Organization (OAPI)10946► Subscribe
Taiwan533205► Subscribe
South Korea20000022222► Subscribe
African Regional IP Organization (ARIPO)9801407► Subscribe
Israel240797► 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: DEFERASIROX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118/01Switzerland► SubscribePRODUCT NAME: DEFERASIROX; REGISTRATION NUMBER/DATE: SWISSMEDIC 57466 03.11.2005
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
0Finland► Subscribe
2006 00035Denmark► Subscribe
0248Netherlands► Subscribe300248, 20170624, 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
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.
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
C 035/2006Ireland► SubscribeSPC 035/2006: 20070528, EXPIRES: 20210827
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Serving leading biopharmaceutical companies globally:

Novartis
Accenture
McKinsey
Citi
QuintilesIMS
Baxter
Cerilliant
Queensland Health
Merck
Cantor Fitzgerald

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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