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Last Updated: October 23, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021335


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NDA 021335 describes GLEEVEC, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There is one patent 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-four suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 021335
Tradename:GLEEVEC
Applicant:Novartis
Ingredient:imatinib mesylate
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021335

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 10, 2001TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 10, 2001TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021335

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-002 May 10, 2001 ⤷  Try it Free ⤷  Try it Free
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 ⤷  Try it Free ⤷  Try it Free
Novartis GLEEVEC imatinib mesylate CAPSULE;ORAL 021335-001 May 10, 2001 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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