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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. Eight suppliers are listed 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
Drug Prices: :see details

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, 2001DISCNNo5,521,184*PEDJul 4, 2015
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes6,894,051*PEDNov 23, 2019Y
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYesDec 19, 2015
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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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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: GLEEVEC

Country Document Number Estimated Expiration
Malaysia128664<disabled in preview>
Norway931283<disabled in preview>
Slovakia28093<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: GLEEVEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0564409/01Switzerland<disabled>PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
C0012France<disabled>PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
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
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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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