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Serving leading biopharmaceutical companies globally:

Moodys
Dow
Farmers Insurance
Julphar
Chubb
Fish and Richardson
Johnson and Johnson
QuintilesIMS
US Army
Colorcon

Generated: January 20, 2018

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.

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

US Patents and Regulatory Information 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) 021877-001 Oct 28, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nelarabine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ARRANON nelarabine INJECTABLE;IV (INFUSION) 021877-001 Oct 28, 2005 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ARRANON nelarabine INJECTABLE;IV (INFUSION) 021877-001 Oct 28, 2005 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ARRANON nelarabine INJECTABLE;IV (INFUSION) 021877-001 Oct 28, 2005 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ARRANON nelarabine INJECTABLE;IV (INFUSION) 021877-001 Oct 28, 2005 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
Patent No. Title Estimated Patent Expiration

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International Patents for nelarabine

Supplementary Protection Certificates for nelarabine

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2007 Austria ➤ Subscribe PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
C0058 France ➤ Subscribe PRODUCT 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
00302 Netherlands ➤ Subscribe PRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
0294114/01 Switzerland ➤ Subscribe PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
07C/063 Belgium ➤ Subscribe PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
C/GB08/006 United Kingdom ➤ Subscribe PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822
0302 Netherlands ➤ Subscribe 300302, 20080527, EXPIRES: 20130526
370 Luxembourg ➤ Subscribe 91370, EXPIRES: 20130527
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
Healthtrust
US Department of Justice
Queensland Health
Teva
Harvard Business School
Argus Health
US Army
McKesson

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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