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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, Barr, and Sun Pharma Global, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: temozolomide

Tradenames:2
Patents:4
Applicants:3
NDAs:4
Drug Master File Entries: see list15
Suppliers: see list3

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: temozolomide

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, 2009RXYes6,987,108<disabled>Y<disabled>
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, 1999RXYes5,260,291*PED<disabled>Y<disabled>
Sun Pharma Global
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL201742Feb 12, 2014RXNo<disabled><disabled>
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