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Serving 500+ biopharmaceutical companies globally:

Dow
UBS
Moodys
Harvard Business School
US Army
Deloitte
Citi
Mallinckrodt
Julphar
Daiichi Sankyo

Generated: August 21, 2017

DrugPatentWatch Database Preview

Imatinib mesylate - Generic Drug Details

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What are the generic drug sources for imatinib mesylate and what is the scope of imatinib mesylate freedom to operate?

Imatinib mesylate
is the generic ingredient in two branded drugs marketed by Novartis, Sun Pharma Global, Mylan Pharms Inc, Apotex Inc, and Teva Pharms Usa, and is included in six NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imatinib mesylate has forty-six patent family members in thirty-one countries.

There are thirty-one drug master file entries for imatinib mesylate. Nine suppliers are listed for this compound.

Summary for Generic Name: imatinib mesylate

Tradenames:2
Patents:4
Applicants:5
NDAs:6
Drug Master File Entries: see list31
Suppliers / Packagers: see list9
Bulk Api Vendors: see list101
Clinical Trials: see list786
Patent Applications: see list8,900
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:imatinib mesylate at DailyMed

Pharmacology for Ingredient: imatinib mesylate

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
Apotex Inc
IMATINIB MESYLATE
imatinib mesylate
TABLET;ORAL079179-002Aug 5, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003ABRXYesYes► 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► Subscribe ► Subscribe
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-002May 10, 2001DISCNYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: imatinib mesylate

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
TABLET;ORAL021588-002Apr 18, 2003► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-002May 10, 2001► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: imatinib mesylate

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 Ingredient: imatinib mesylate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9903854► Subscribe
Russian Federation2208012► Subscribe
China1264375► Subscribe
Malaysia128664► Subscribe
New Zealand502295► 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: IMATINIB MESYLATE

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
0564409/01Switzerland► SubscribePRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Dow
Baxter
Johnson and Johnson
Chinese Patent Office
UBS
Colorcon
Cerilliant
Teva
Daiichi Sankyo

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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