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Nelarabine - Generic Drug Details

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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.

This ingredient has forty-three patent family members in twenty-eight countries.

There is one drug master file entry for nelarabine. One supplier is listed for this compound.

Summary for Generic Name: nelarabine

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: nelarabine

Clinical Trials for: nelarabine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 2005RXYes5,424,295Jun 13, 2017YY
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Expired Orange Book Patents for Generic Ingredient: nelarabine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,492,897<disabled>
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,821,236<disabled>
Novartis Pharms Corp
ARRANON
nelarabine
INJECTABLE;IV (INFUSION)021877-001Oct 28, 20055,747,472<disabled>
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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<disabled in preview>
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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
Greece3021257<disabled in preview>
Denmark171670<disabled in preview>
United Kingdom8712745<disabled in preview>
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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
0294114/01Switzerland<disabled>PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
07C/063Belgium<disabled>PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
370Luxembourg<disabled>91370, EXPIRES: 20130527
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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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