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Details for Generic Name: gefitinib

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Gefitinib is the generic ingredient in one branded drug marketed by Astrazeneca and Astrazeneca Pharms, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-five patent family members in thirty-five countries.

There are four drug master file entries for gefitinib. One supplier is listed for this compound.

Summary for Generic Name: gefitinib

Drug Master File Entries: see list4
Suppliers / Packaging: see list1
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for Ingredient: gefitinib

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: gefitinib

Hydroxychloroquine and Gefitinib to Treat Lung Cancer
Status: Recruiting Condition: Non-small Cell Lung Cancer

Gefitinib in Treating Patients Who Are Undergoing Surgery and/or Radiation Therapy for Locally Advanced or Recurrent Squamous Cell Skin Cancer
Status: Completed Condition: Recurrent Skin Cancer; Squamous Cell Carcinoma of the Skin

Study of Gefitinib Retreatment in Non-Small Cell Lung Cancer (NSCLC)
Status: Completed Condition: Carcinoma, Non-Small-Cell Lung

High Dose Gefitinib for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
Status: Active, not recruiting Condition: Non-Small Cell Lung Cancer

Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Status: Completed Condition: Myelogenous Leukemia, Acute

Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
Status: Completed Condition: Untreated Childhood Anaplastic Astrocytoma; Untreated Childhood Anaplastic Oligodendroglioma; Untreated Childhood Brain Stem Glioma; Untreated Childhood Giant Cell Glioblastoma; Untreated Childhood Glioblastoma; Untreated Childhood Gliomatosis Cerebri; Untreated Childhood Gliosarcoma; Untreated Childhood Oligodendroglioma

First Line Gefitinib by FDG-PET Metabolic Response
Status: Recruiting Condition: Non-small Cell Lung Cancer

Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer
Status: Completed Condition: Head and Neck Cancer

Erlotinib Versus Gefitinib in Advanced Non Small Cell Lung Cancer With exon21 Mutation:A Randomized Trial
Status: Completed Condition: Thoracic Neoplasms

Vinorelbine-ifosfamide Versus Gefitinib for EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients
Status: Recruiting Condition: Non-small Cell Lung Cancer; Effects of Chemotherapy

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
Astrazeneca Pharms
TABLET;ORAL206995-001Jul 13, 2015RXYes<disabled><disabled>
TABLET;ORAL021399-001May 5, 2003DISCNNo5,770,599<disabled>YY <disabled>
Astrazeneca Pharms
TABLET;ORAL206995-001Jul 13, 2015RXYes<disabled><disabled>
Astrazeneca Pharms
TABLET;ORAL206995-001Jul 13, 2015RXYes5,770,599<disabled>YY <disabled>
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International Patent Family for Ingredient: gefitinib

Country Document Number Publication Date
Canada2215732Apr 09, 2002
Poland323066Mar 02, 1998
Slovenia0823900Jun 30, 2001
New Zealand305444Mar 29, 1999
Israel118045Oct 31, 2001
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ISSN: 2162-2639

Preferred citation:

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

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