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Last Updated: August 12, 2020

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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, Amerigen Pharms Ltd, Amneal Pharms, Apotex Inc, Barr, Chartwell, Chemi Spa, Deva Holding As, 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.

Drug Prices for temozolomide

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Recent Clinical Trials for temozolomide

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

SponsorPhase
Hangzhou Medical Biotechnology Co., LtdPhase 1/Phase 2
MetVital, Inc.Phase 2
CyTIX.IncPhase 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 203691-004 May 8, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Chemi Spa TEMOZOLOMIDE temozolomide CAPSULE;ORAL 204639-003 Nov 23, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Amerigen Pharms Ltd TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203490-005 Jul 13, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Deva Holding As TEMOZOLOMIDE temozolomide CAPSULE;ORAL 207658-006 Apr 26, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Lannett Co Inc TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898-006 Feb 10, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-004 Aug 11, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lannett Co Inc TEMOZOLOMIDE temozolomide CAPSULE;ORAL 203898-004 Feb 10, 2016 DISCN No No   Start Trial   Start Trial   Start 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 021029-004 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-001 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide POWDER;INTRAVENOUS 022277-001 Feb 27, 2009   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-003 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-002 Aug 11, 1999   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-005 Oct 19, 2006   Start Trial   Start Trial
Merck Sharp Dohme TEMODAR temozolomide CAPSULE;ORAL 021029-006 Oct 19, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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