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TEMODAR Drug Profile

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Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from two 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. Eight 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 list2

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>
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Expired Patents for Tradename: TEMODAR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-006Oct 19, 20065,260,291*PED<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 19995,260,291*PED<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-003Aug 11, 19995,260,291*PED<disabled>
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Paragraph IV activity for: TEMODAR

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

Non-Orange Book Patents for Tradename: TEMODAR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents<disabled in preview>
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents<disabled in preview>
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International Patent Family for Tradename: TEMODAR

Country Document Number Estimated Expiration
Canada2662899<disabled in preview>
China1635871<disabled in preview>
Poland372319<disabled in preview>
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