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Last Updated: February 3, 2023

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, Nivagen Pharms Inc, Rising, Sun Pharm, Watson Labs Teva, and Zydus Pharms, and is included in seventeen 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. Twelve 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
University of Alabama at BirminghamEarly Phase 1
University of ZurichPhase 1/Phase 2
Swiss National Science FoundationPhase 1/Phase 2

See all temozolomide clinical trials

Pharmacology for temozolomide
Drug Class Alkylating 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
Amneal Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691-005 May 8, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Deva Holding As TEMOZOLOMIDE temozolomide CAPSULE;ORAL 207658-006 Apr 26, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ani Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203490-005 Jul 13, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203691-004 May 8, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021029-006 Oct 19, 2006 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 See Plans and Pricing See Plans and Pricing
>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
Teva B.V.  Temozolomide Teva temozolomide EMEA/H/C/001126
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 2010-01-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for temozolomide

Country Patent Number Title Estimated Expiration
Cyprus 1108291 See Plans and Pricing
European Patent Office 1938798 Formulations pharmaceutiques d'agents antinéoplastiques, en particulier du témozolomide, leurs procédés de fabrication et leur utilisation (Pharmaceutical formulations of antineoplastic agents, in particular temozolomide, processes of making and using the same) See Plans and Pricing
China 1635871 Pharmaceutical formulations of antineoplastic agents, in particular temozolomide, processes of making and using the same See Plans and Pricing
Norway 20043961 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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