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Last Updated: September 26, 2022

TEMODAR Drug Patent Profile


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Which patents cover Temodar, and when can generic versions of Temodar launch?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-six patent family members in twenty-three countries.

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

Summary for TEMODAR
Drug patent expirations by year for TEMODAR
Drug Prices for TEMODAR

See drug prices for TEMODAR

Recent Clinical Trials for TEMODAR

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

SponsorPhase
Innovative Therapies For Children with Cancer ConsortiumPhase 1/Phase 2
Merck Sharp & Dohme LLCPhase 2
L. Nicolas Gonzalez Castro, MD, PhDPhase 2

See all TEMODAR clinical trials

Pharmacology for TEMODAR
Drug Class Alkylating 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

TEMODAR is protected by three US patents.

Patents protecting TEMODAR

Pharmaceutical formulations of antineoplastic agents and processes of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations of antineoplastic agents
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Processes of making and using pharmaceutical formulations of antineoplastic agents
Patent Number: See Plans and Pricing
Patent Expiration: 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
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 AB RX Yes Yes 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 TEMODAR

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.
Authorised yes no no 2010-03-15
Sandoz GmbH Temozolomide Sandoz temozolomide EMEA/H/C/001128
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
>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
Australia 8749382 See Plans and Pricing
Austria 397440 See Plans and Pricing
Ireland 822026 See Plans and Pricing
Slovakia 282452 See Plans and Pricing
Russian Federation 2148401 PHARMACEUTICAL COMPOSITION SHOWING ANTITUMOR ACTIVITY AND METHOD OF ITS PREPARING See Plans and Pricing
Australia 2003213142 PHARMACEUTICAL FORMULATIONS OF ANTINEOPLASTIC AGENTS, IN PARTICULAR TEMOZOLOMIDE, PROCESSES OF MAKING AND USING THE SAME See Plans and Pricing
Canada 2476494 FORMULATIONS PHARMACEUTIQUES D'AGENTS ANTI-NEOPLASTIQUES, NOTAMMENT LA TEMOZOLOMIDE ET PROCEDES DE FABRICATION ET D'UTILISATION ASSOCIES (PHARMACEUTICAL FORMULATIONS OF ANTINEOPLASTIC AGENTS, IN PARTICULAR TEMOZOLOMIDE, PROCESSES OF MAKING AND USING THE SAME) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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