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Serving 500+ biopharmaceutical companies globally:

Novartis
UBS
Merck
QuintilesIMS
Chubb
Accenture
AstraZeneca
Johnson and Johnson
Healthtrust
Argus Health

Generated: July 26, 2017

DrugPatentWatch Database Preview

GLEEVEC Drug Profile

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What is the patent landscape for Gleevec, and when can generic versions of Gleevec launch?

Gleevec is a drug marketed by Novartis and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has forty-six patent family members in thirty-one countries.

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

Summary for Tradename: GLEEVEC

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Bulk Api Vendors: see list101
Clinical Trials: see list182
Patent Applications: see list6,027
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:GLEEVEC at DailyMed

Pharmacology for Tradename: GLEEVEC

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001DISCNYesNo► Subscribe► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-002May 10, 2001DISCNYesNo► Subscribe► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003ABRXYesYes► Subscribe► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: GLEEVEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-002May 10, 2001► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003► Subscribe► Subscribe
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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
7,151,106Crystal modification of a N-phenyl-2-pyrimidineamine derivative, processes for its manufacture and its use► Subscribe
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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
Brazil9810920► Subscribe
World Intellectual Property Organization (WIPO)9903854► Subscribe
Indonesia24093► Subscribe
China1264375► Subscribe
Russian Federation2208012► Subscribe
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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
02/005Ireland► SubscribePRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
C/GB02/016United Kingdom► SubscribePRODUCT 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► SubscribePRODUCT 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
C0012France► SubscribePRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409/01Switzerland► SubscribePRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Deloitte
Julphar
Chubb
Cantor Fitzgerald
Moodys
Fish and Richardson
Accenture
AstraZeneca
QuintilesIMS
Teva

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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