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ARRANON Drug Profile

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Arranon is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

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

The generic ingredient in ARRANON is nelarabine. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nelarabine profile page.

Summary for Tradename: ARRANON

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ARRANON

Clinical Trials for: ARRANON

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, 2005RXYes5,424,295<disabled>YY <disabled>
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Expired Patents for Tradename: ARRANON

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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 Tradename: ARRANON

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 Tradename: ARRANON

Country Document Number Estimated Expiration
Philippines27292<disabled in preview>
Austria142636<disabled in preview>
Hong Kong78497<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: ARRANON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/006United Kingdom<disabled>PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822
00302Netherlands<disabled>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
0294114/01Switzerland<disabled>PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
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