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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 four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in TEMODAR is temozolomide. There are fifteen 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

Patents:4
Applicants:1
NDAs:2
Suppliers: see list3

Pharmacology for Tradename: TEMODAR

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: TEMODAR

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

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

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: Completed Condition: Melanoma

Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
Status: Active, not recruiting Condition: Glioblastoma Multiforme; Gliosarcoma

Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma
Status: Completed Condition: Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)
Status: Completed Condition: Glioblastoma; Glioma; Astrocytoma

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

Temozolomide in Treating Patients With Recurrent High-Grade Glioma
Status: Completed Condition: Recurrent Central Nervous System Neoplasm

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277Feb 27, 2009RXYes5,260,291*PED<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277Feb 27, 2009RXYes8,623,868<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029Aug 11, 1999RXNo5,260,291*PED<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277Feb 27, 2009RXYes6,987,108<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029Aug 11, 1999RXYes5,260,291*PED<disabled>Y<disabled>
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Paragraph IV activity for: TEMODAR

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