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Profile for Tradename: IRESSA

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Iressa is a drug marketed by Astrazeneca and Astrazeneca Pharms and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug.

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

The generic ingredient in IRESSA is gefitinib. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gefitinib profile page.

Summary for Tradename: IRESSA

Suppliers / Packagers: see list1

Pharmacology for Tradename: IRESSA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Clinical Trials for: IRESSA

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

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

An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Status: Completed Condition: Mesothelioma

Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer
Status: Terminated Condition: BREAST 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

A Feasibility Study With Iressa in Resistant Cytokeratin-Positive Tumor Cells Circulating in the Blood of Women With Breast Cancer
Status: Completed Condition: Breast Cancer

ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Status: Completed Condition: Skin Cancer

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

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

Phase 2 Study Of Neoadjuvant Iressa Treatment In Stage 1 NSCLC
Status: Completed Condition: LUNG CANCER

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
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 Tradename: IRESSA

Country Document Number Publication Date
Hungary9802839Feb 28, 2001
Netherlands300429Mar 01, 2010
China1100046Jan 29, 2003
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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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