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GLEEVEC Drug Profile

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Gleevec is a drug marketed by Novartis and is included in two NDAs. It is available from three suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has ninety-one patent family members in thirty-eight countries.

The generic ingredient in GLEEVEC is imatinib mesylate. There are twenty-eight drug master file entries for this compound. Five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for Tradename: GLEEVEC

Patents:5
Applicants:1
NDAs:2
Suppliers / Packagers: see list3

Pharmacology for Tradename: GLEEVEC

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: GLEEVEC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001DISCNNoRE43932*PED<disabled> <disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes7,544,799*PED<disabled>Y<disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes<disabled><disabled>
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Expired Patents for Tradename: GLEEVEC

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 20015,521,184*PED<disabled>
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 20035,521,184*PED<disabled>
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-002May 10, 20015,521,184*PED<disabled>
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Paragraph IV activity for: GLEEVEC

Drugname Dosage Strength RLD Submissiondate
imatinib mesylateTablets100 mg and 400 mgGleevec3/12/2007
imatinib mesylateCapsules400 mgGleevec1/24/2014

Non-Orange Book Patents for Tradename: GLEEVEC

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
5,543,520 Pyrimidine derivatives<disabled in preview>
7,151,106Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use<disabled in preview>
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International Patent Family for Tradename: GLEEVEC

Country Document Number Estimated Expiration
Hungary9300982<disabled in preview>
Australia740713<disabled in preview>
Brazil9810920<disabled in preview>
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Supplementary Protection Certificates for Tradename: GLEEVEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB02/016United Kingdom<disabled>PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
00086Netherlands<disabled>PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621
2002 00005Denmark<disabled>
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