Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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 one supplier. There are three 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-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 021588
Tradename:GLEEVEC
Applicant:Novartis
Ingredient:imatinib mesylate
Patents:3
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 0078-0649 0078-0649-30 30 TABLET in 1 BOX, UNIT-DOSE (0078-0649-30)
Paragraph IV (Patent) Challenges for 021588
Tradename Dosage Ingredient NDA Submissiondate
GLEEVEC TABLET;ORAL imatinib mesylate 021588

Profile 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:TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ ALL) IN COMBINATION WITH CHEMOTHERAPY, APPROVED UNDER NDA #21588/S-037
Patent:  Start TrialPatent Expiration:Nov 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021588

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-002 Apr 18, 2003   Start Trial   Start Trial
Novartis GLEEVEC imatinib mesylate TABLET;ORAL 021588-001 Apr 18, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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