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Generated: April 27, 2017

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Imatinib mesylate - Generic Drug Details

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

Imatinib mesylate
is the generic ingredient in two branded drugs marketed by Novartis, Sun Pharma Global, Apotex Inc, and Teva Pharms Usa, and is included in five NDAs. There are five 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:5
Applicants:4
NDAs:5
Drug Master File Entries: see list31
Suppliers / Packagers: see list9
Bulk Api Vendors: see list101
Clinical Trials: see list278
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
Novartis
GLEEVEC
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001DISCNYesNo6,894,051*PED► SubscribeY► Subscribe
Teva Pharms Usa
IMATINIB MESYLATE
imatinib mesylate
TABLET;ORAL204285-002Aug 4, 2016ABRXNoNo► Subscribe► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003ABRXYesYes7,544,799*PED► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003ABRXYesNo6,958,335*PED► SubscribeY► Subscribe
Novartis
GLEEVEC
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 2003ABRXYesNo7,544,799*PED► SubscribeY► Subscribe
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