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Last Updated: July 13, 2020

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TEMODAR Drug Profile


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Which patents cover Temodar, and when can generic versions of Temodar launch?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-three countries.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.

US ANDA Litigation and Generic Entry Outlook for Temodar

A generic version of TEMODAR was approved as temozolomide by BARR on March 1st, 2010.

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Drug patent expirations by year for TEMODAR
Drug Prices for TEMODAR

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Recent Clinical Trials for TEMODAR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Valent Technologies, Inc.Phase 1
NeuGATE TheranosticsPhase 1/Phase 2
M.D. Anderson Cancer CenterEarly Phase 1

See all TEMODAR clinical trials

Pharmacology for TEMODAR
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for TEMODAR
Tradename Dosage Ingredient NDA Submissiondate
TEMODAR CAPSULE;ORAL temozolomide 021029 2008-03-24
TEMODAR CAPSULE;ORAL temozolomide 021029 2007-03-20

US Patents and Regulatory Information for TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Harvard Business School
Dow
Boehringer Ingelheim
Express Scripts

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