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Last Updated: March 29, 2024

TEMODAR Drug Patent Profile


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When do Temodar patents expire, and what generic alternatives are available?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Temodar

A generic version of TEMODAR was approved as temozolomide by SUN PHARM on February 12th, 2014.

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Drug patent expirations by year for TEMODAR
Drug Prices for TEMODAR

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Recent Clinical Trials for TEMODAR

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

SponsorPhase
Xynomic Pharmaceuticals, Inc.Phase 1
Orbus Therapeutics, Inc.Phase 1
Kari KendraPhase 1/Phase 2

See all TEMODAR clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 DISCN Yes 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 TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TEMODAR

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
Merck Sharp & Dohme B.V.  Temodal temozolomide EMEA/H/C/000229
Temodal hard capsules is indicated for the treatment of:adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy 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 no no no 1999-01-26
Hexal AG Temozolomide Hexal temozolomide EMEA/H/C/001127
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.
Withdrawn yes no no 2010-03-15
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TEMODAR

See the table below for patents covering TEMODAR around the world.

Country Patent Number Title Estimated Expiration
China 1117711 ⤷  Try a Trial
Germany 3231255 ⤷  Try a Trial
Austria 397440 ⤷  Try a Trial
European Patent Office 1478339 FORMULATIONS PHARMACEUTIQUES D'AGENTS ANTI-NÉOPLASTIQUES, NOTAMMENT LA TEMOZOLOMIDE, ET PROCÉDÉS DE FABRICATION ET D'UTILISATION ASSOCIÉS (PHARMACEUTICAL FORMULATIONS OF ANTINEOPLASTIC AGENTS, IN PARTICULAR TEMOZOLOMIDE, PROCESSES OF MAKING AND USING THE SAME) ⤷  Try a Trial
Spain 8400438 ⤷  Try a Trial
South Africa 200406632 PHARMACEUTICAL FORMULATIONS OF ANTINEOPLASTIC AGENTS IN PARTICULAR TEMOZOLOMIDE PROCESSES OF MAKING AND USING THE SAME ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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