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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

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list36

Pharmacology for Tradename: TEMODAR

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: TEMODAR

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
CAPSULE;ORAL021029-001Aug 11, 1999RXNo<disabled><disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYes6,987,108<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 2006RXNo<disabled><disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYes7,786,118<disabled>Y<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-002Aug 11, 1999RXNo<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
Spain2307905Dec 01, 2008
Denmark1478339Aug 25, 2008
Australia2003213142Nov 10, 2005
Argentina038535Jan 19, 2005
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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