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Details for Generic Name: temozolomide

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Temozolomide is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Amneal Pharms, Barr, and Sun Pharma Global, and is included in five NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are sixteen drug master file entries for temozolomide. Three suppliers are listed for this compound.

Summary for Generic Name: temozolomide

Drug Master File Entries: see list16
Suppliers / Packaging: see list36
Formulation / Manufacturing:see details

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: temozolomide

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

ABT-888 and Temozolomide for Liver Cancer
Status: Active, not recruiting Condition: Hepatocellular Carcinoma

Bevacizumab, Irinotecan and Temozolomide for Relapsed or Refractory Neuroblastoma
Status: Active, not recruiting Condition: Neuroblastoma

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

A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Status: Active, not recruiting Condition: Glioblastoma

Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas
Status: Completed Condition: Glioblastoma; 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

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
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYes8,623,868<disabled>Y <disabled>
Amneal Pharms
CAPSULE;ORAL203691-001May 8, 2015RXNo<disabled><disabled>
Amneal Pharms
CAPSULE;ORAL203691-003May 8, 2015RXNo<disabled><disabled>
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International Patent Family for Ingredient: temozolomide

Country Document Number Publication Date
Norway20043961Sep 21, 2004
Slovenia1478339Oct 31, 2008
Canada2662899Sep 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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