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Serving leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
Queensland Health

Generated: December 16, 2017

DrugPatentWatch Database Preview

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 four 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 thirty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for 021588

Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 021588

Mechanism of ActionProtein Kinase Inhibitors

Medical Subject Heading (MeSH) Categories for 021588

Suppliers and Packaging for NDA: 021588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLEEVEC imatinib mesylate TABLET;ORAL 021588 NDA Novartis Pharmaceuticals Corporation 0078-0401 0078-0401-34 90 TABLET in 1 BOTTLE (0078-0401-34)
GLEEVEC 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:Yes
Regulatory Exclusivity Expiration:Jan 25, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Nov 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021588

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisGLEEVECimatinib mesylateTABLET;ORAL021588-001Apr 18, 2003► Subscribe► Subscribe
NovartisGLEEVECimatinib mesylateTABLET;ORAL021588-002Apr 18, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Boehringer Ingelheim
Johnson and Johnson
Harvard Business School
US Army
Federal Trade Commission

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