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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

TEMOZOLOMIDE - Generic Drug Details

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What are the generic drug sources for temozolomide and what is the scope of freedom to operate?

Temozolomide is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Lannett Co Inc, Mylan, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in sixteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for TEMOZOLOMIDE

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Recent Clinical Trials for TEMOZOLOMIDE

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

SponsorPhase
CyTIX.IncPhase 1/Phase 2
Hangzhou Medical Biotechnology Co., LtdPhase 1/Phase 2
MetVital, Inc.Phase 2

See all TEMOZOLOMIDE clinical trials

Pharmacology for TEMOZOLOMIDE
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for TEMOZOLOMIDE
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 TEMOZOLOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr TEMOZOLOMIDE temozolomide CAPSULE;ORAL 078879-001 Mar 1, 2010 AB RX No No   Start Trial   Start Trial   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 021029-005 Oct 19, 2006 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 TEMOZOLOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 CAPSULE;ORAL 021029-003 Aug 11, 1999   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:

Moodys
Boehringer Ingelheim
Mallinckrodt
Medtronic
Colorcon
Baxter

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