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Profile for Tradename: TEMODAR

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Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-three countries.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

Summary for Tradename: TEMODAR

Suppliers / Packagers: see list36

Pharmacology for Tradename: TEMODAR

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: TEMODAR

Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)
Status: Active, not recruiting Condition: Glioblastoma Multiforme; Gliosarcoma

Sarasar and Temodar for Glioblastoma Multiforme Patients
Status: Active, not recruiting Condition: Glioblastoma Multiforme; Gliosarcoma; Brain Tumors

Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors
Status: Completed Condition: Glioblastoma Multiforme; Gliosarcoma

A Phase I/II Study of TPI 287 - Temozolomide Combination in Melanoma
Status: Recruiting Condition: Melanoma

Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma
Status: Completed Condition: Glioblastoma Multiforme; Anaplastic Glioma

Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas
Status: Completed Condition: Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma

Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
Status: Terminated Condition: Brain Cancer; Glioblastoma Multiforme

Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
Status: Completed Condition: Glioblastoma; Gliosarcoma

Taxotere/Temodar/Cisplatin Study in Melanoma Patients
Status: Completed Condition: Metastatic Melanoma

Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma
Status: Recruiting Condition: Adult Glioblastoma

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
Merck Sharp Dohme
CAPSULE;ORAL021029-001Aug 11, 1999RXNo<disabled><disabled>
Merck Sharp Dohme
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYes6,987,108<disabled>Y <disabled>
Merck Sharp Dohme
CAPSULE;ORAL021029-005Oct 19, 2006RXNo<disabled><disabled>
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Paragraph IV activity for: TEMODAR

Drugname Dosage Strength RLD Submissiondate
temozolomideCapsules140 mg and 180 mgTemodar3/24/2008

International Patent Family for Tradename: TEMODAR

Country Document Number Publication Date
South Korea20040085196Oct 07, 2004
Spain2307905Dec 01, 2008
World Intellectual Property Organization (WIPO)03072082Sep 04, 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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