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Generated: October 17, 2017

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NELARABINE - Generic Drug Details

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

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.

Summary for Generic Name: NELARABINE

US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list47
Clinical Trials: see list23
Patent Applications: see list5,110
Drug Prices:see low prices
DailyMed Link:NELARABINE at DailyMed

Pharmacology for Ingredient: 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
Denmark289788► Subscribe
European Patent Office0294114► Subscribe
Portugal87592► Subscribe
United Kingdom8712745► Subscribe
HungaryT47129► Subscribe
Hong Kong78497► Subscribe
Norway2007016► Subscribe
Cyprus2001► Subscribe
Denmark171670► Subscribe
Czechoslovakia277006► 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
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
0294114/01Switzerland► SubscribePRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
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
07C/063Belgium► SubscribePRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
/2007Austria► SubscribePRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 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
0302Netherlands► Subscribe300302, 20080527, EXPIRES: 20130526
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Citi
McKinsey
Cerilliant
Harvard Business School
Covington
US Army
Argus Health
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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