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Details for New Drug Application (NDA): 021588

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NDA 021588 describes GLEEVEC, which 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. Additional details are available on the GLEEVEC profile page.

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 NDA: 021588

imatinib mesylate
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021588

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 021588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
imatinib mesylate
TABLET;ORAL 021588 NDA Novartis Pharmaceuticals Corporation 0078-0401 0078-0401-34 90 TABLET in 1 BOTTLE (0078-0401-34)
imatinib mesylate
TABLET;ORAL 021588 NDA Novartis Pharmaceuticals Corporation 0078-0438 0078-0438-15 30 TABLET in 1 BOTTLE (0078-0438-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 18, 2003TE:ABRLD:No
Patent:5,521,184*PEDPatent Expiration:Jul 4, 2015Product Flag?Substance Flag?Delist Request?
Patent:6,894,051*PEDPatent Expiration:Nov 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:6,958,335*PEDPatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021588

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
imatinib mesylate
TABLET;ORAL021588-001Apr 18, 20035,521,184*PED<disabled>
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 20035,521,184*PED<disabled>
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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.