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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Argus Health
Harvard Business School

Generated: June 23, 2018

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 two 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-three drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 021335
Ingredient:imatinib mesylate
Therapeutic Class:Antineoplastics
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50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:➤ Sign UpPatent Expiration:Nov 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jun 19, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jan 16, 2019Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Johnson and Johnson

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