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Last Updated: April 15, 2024

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, Amneal Pharms, Ani Pharms, Apotex, Chartwell, Chartwell Molecular, Chemi Spa, Deva Holding As, Heritage, Mylan, Nivagen Pharms Inc, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for temozolomide

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Recent Clinical Trials for temozolomide

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SponsorPhase
CarTheraPhase 3
Xynomic Pharmaceuticals, Inc.Phase 1
Ruijin HospitalPhase 2

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Pharmacology for temozolomide
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for TEMOZOLOMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEMODAR Capsules temozolomide 140 mg and 180 mg 021029 1 2008-03-24
TEMODAR Capsules temozolomide 5 mg, 20 mg, 100 mg and 250 mg 021029 1 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
Mylan TEMOZOLOMIDE temozolomide CAPSULE;ORAL 205227-002 Jun 29, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare TEMOZOLOMIDE temozolomide CAPSULE;ORAL 201528-006 Feb 27, 2017 AB RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691-003 May 8, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 021029-003 Aug 11, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for temozolomide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH Temomedac temozolomide EMEA/H/C/001124
Temomedac hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Authorised yes no no 2010-01-25
Accord Healthcare S.L.U. Temozolomide Accord temozolomide EMEA/H/C/001125
For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Authorised yes no no 2010-03-15
Sun Pharmaceutical Industries Europe B.V. Temozolomide Sun temozolomide EMEA/H/C/002198
Temozolomide Sun is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment;children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Authorised yes no no 2011-07-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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