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Serving leading biopharmaceutical companies globally:

Cipla
Chubb
Baxter
Deloitte
Fish and Richardson
Boehringer Ingelheim
US Department of Justice
Mallinckrodt
Daiichi Sankyo
Fuji

Generated: November 19, 2017

DrugPatentWatch Database Preview

Nelarabine - Generic Drug Details

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What are the generic drug sources for nelarabine and what is the scope of nelarabine patent protection?

Nelarabine
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Nelarabine has forty-three patent family members in twenty-eight countries and eight supplementary protection certificates in seven countries.

There are two drug master file entries for nelarabine. Two suppliers are listed for this compound.

Pharmacology for nelarabine

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
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nelarabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005► Subscribe► Subscribe
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005► Subscribe► Subscribe
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005► Subscribe► Subscribe
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: nelarabine

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
5,539,098 5'-O-propionyl and 5'-O-butyryl esters of 2-amino-6-methoxy-9-(.beta.-D-arabinofuranosyl)-9H-purine► 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: nelarabine

Country Document Number Estimated Expiration
Poland157684► Subscribe
Portugal87592► Subscribe
Germany122008000003► Subscribe
China1020107► Subscribe
Norway882357► Subscribe
Finland882511► Subscribe
HungaryT47129► Subscribe
European Patent Office0294114► Subscribe
Canada1330990► Subscribe
JapanS63310831► 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: NELARABINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0302Netherlands► Subscribe300302, 20080527, EXPIRES: 20130526
0294114/01Switzerland► SubscribePRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
07C/063Belgium► SubscribePRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
00302Netherlands► SubscribePRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
/2007Austria► SubscribePRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
C0058France► SubscribePRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
370Luxembourg► Subscribe91370, EXPIRES: 20130527
C/GB08/006United Kingdom► SubscribePRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Deloitte
Dow
Federal Trade Commission
Boehringer Ingelheim
US Army
Fish and Richardson
Accenture
QuintilesIMS

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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