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Profile for Tradename: GLEEVEC

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Gleevec is a drug marketed by Novartis and is included in two NDAs. It is available from two suppliers. There are five patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in GLEEVEC is imatinib mesylate. There are twenty-seven drug master file entries for this compound. Two suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for Tradename: GLEEVEC

Suppliers / Packagers: see list4
2013 Sales:$1,896,982,000

Pharmacology for Tradename: GLEEVEC

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: GLEEVEC

Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform Neurofibromas
Status: Active, not recruiting Condition: Neurofibromatosis; Neurofibromas

Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients
Status: Terminated Condition: Chronic Lymphocytic Leukemia

Therapy of Early Chronic Phase CML With Gleevec
Status: Completed Condition: Leukemia, Myeloid, Chronic-Phase

Effect of Antacids on Gleevec® in Healthy Volunteers
Status: Completed Condition: Healthy

Gleevec/Taxol for Patients With Uterine Papillary Serous Carcinoma
Status: Completed Condition: Uterine Cancer

Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG
Status: Completed Condition: Glioblastoma; Gliosarcoma

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Status: Completed Condition: Ovarian Cancer; Primary Peritoneal Cancer

Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
Status: Terminated Condition: Chronic Myeloid Leukemia (CML); Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL); Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)

Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse Scleroderma
Status: Terminated Condition: Scleroderma

High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)
Status: Completed Condition: Leukemia, Myeloid, Chronic

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
imatinib mesylate
CAPSULE;ORAL021335-001May 10, 2001DISCNNoRE43932*PED<disabled> <disabled>
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes7,544,799*PED<disabled>Y<disabled>
imatinib mesylate
TABLET;ORAL021588-002Apr 18, 2003RXYes<disabled><disabled>
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Paragraph IV activity for: GLEEVEC

Drugname Dosage Strength RLD Submissiondate
imatinib mesylateTablets100 mg and 400 mgGleevec3/12/2007
imatinib mesylateCapsules400 mgGleevec1/24/2014
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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