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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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International Patent Family for Tradename: ARRANON

Country Document Number Estimated Expiration
Finland89805<disabled in preview>
HungaryT47129<disabled in preview>
China1020107<disabled in preview>
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Supplementary Protection Certificates for Tradename: ARRANON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0302Netherlands<disabled>300302, 20080527, EXPIRES: 20130526
07C/063Belgium<disabled>PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823
370Luxembourg<disabled>91370, EXPIRES: 20130527
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