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Last Updated: January 26, 2021

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TEMOZOLOMIDE Drug Profile

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Which patents cover Temozolomide, and what generic alternatives are available?

Temozolomide is a drug marketed by Accord Hlthcare, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Barr, Chartwell, Chemi Spa, Deva Holding As, Lannett Co Inc, Mylan, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms. and is included in fourteen NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Temozolomide

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

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Drug patent expirations by year for TEMOZOLOMIDE
Drug Prices for TEMOZOLOMIDE

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Recent Clinical Trials for TEMOZOLOMIDE

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SponsorPhase
Hangzhou Normal UniversityPhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 2
ClinSearchPhase 1

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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
Sun Pharm TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201742-006 Feb 12, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Chemi Spa TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204639-005 Nov 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206413-002 Apr 12, 2016 AB RX No 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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Moodys
Colorcon
Medtronic
McKesson

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