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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Federal Trade Commission
Colorcon
Johnson and Johnson
McKesson
Queensland Health
Express Scripts
Dow
US Department of Justice

Generated: December 18, 2017

DrugPatentWatch Database Preview

Temozolomide - Generic Drug Details

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What are the generic drug sources for temozolomide and what is the scope of temozolomide patent protection?

Temozolomide
is the generic ingredient in two branded drugs marketed by Merck Sharp Dohme, Accord Hlthcare, Amerigen Pharms Ltd, Amneal Pharms, Barr, Chemi Spa, Deva Holding As, Idt Australia Ltd, Kremers Urban Pharms, Mylan Pharms Inc, Rising Pharms Inc, Sun Pharma Global, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in fifteen 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-five patent family members in twenty-three countries.

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

Pharmacology for temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Deva Holding AsTEMOZOLOMIDEtemozolomideCAPSULE;ORAL207658-005Apr 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Chemi SpaTEMOZOLOMIDEtemozolomideCAPSULE;ORAL204639-006Nov 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Amerigen Pharms LtdTEMOZOLOMIDEtemozolomideCAPSULE;ORAL203490-006Jul 13, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal PharmsTEMOZOLOMIDEtemozolomideCAPSULE;ORAL203691-002May 8, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms IncTEMOZOLOMIDEtemozolomideCAPSULE;ORAL205227-006Jun 29, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalTEMOZOLOMIDEtemozolomideCAPSULE;ORAL201742-005Feb 12, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Idt Australia LtdTEMOZOLOMIDEtemozolomideCAPSULE;ORAL206413-004Apr 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
BarrTEMOZOLOMIDEtemozolomideCAPSULE;ORAL078879-004Mar 1, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa IncTEMOZOLOMIDEtemozolomideCAPSULE;ORAL206750-004Jul 31, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Accord HlthcareTEMOZOLOMIDEtemozolomideCAPSULE;ORAL201528-004Feb 27, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: temozolomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-006Oct 19, 2006► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-001Aug 11, 1999► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-004Aug 11, 1999► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-005Oct 19, 2006► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-003Aug 11, 1999► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-002Aug 11, 1999► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: temozolomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents► Subscribe
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: temozolomide

Country Document Number Estimated Expiration
Portugal1478339► Subscribe
European Patent Office1478339► Subscribe
MexicoPA04008133► Subscribe
Canada2662899► Subscribe
Poland205936► Subscribe
Argentina084868► Subscribe
Austria397440► Subscribe
Cyprus1108291► Subscribe
Germany60321450► Subscribe
Japan4077794► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Novartis
Baxter
McKesson
Chubb
Johnson and Johnson
Deloitte
Express Scripts
Cantor Fitzgerald
Farmers Insurance
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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