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Last Updated: October 20, 2021

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Temozolomide - Generic Drug Details

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What are the generic sources for temozolomide and what is the scope of patent protection?

Temozolomide is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Accord Hlthcare, Amneal Pharms, Ani Pharms, Apotex Inc, Chartwell, Chemi Spa, Deva Holding As, Heritage, 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.

Summary for temozolomide
Drug Prices for temozolomide

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Recent Clinical Trials for temozolomide

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

SponsorPhase
Andrew Sloan, MDPhase 2
Hopital FochPhase 2
Mayo ClinicPhase 1/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
Amneal Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691-003 May 8, 2015 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Heritage TEMOZOLOMIDE temozolomide CAPSULE;ORAL 078879-002 Mar 1, 2010 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206750-006 Jul 31, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Chemi Spa TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204639-004 Nov 23, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett Co Inc TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898-001 Feb 10, 2016 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Rising TEMOZOLOMIDE temozolomide CAPSULE;ORAL 206309-006 Apr 27, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Johnson and Johnson
McKesson
Moodys
AstraZeneca

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