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Temozolomide - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for temozolomide?

Temozolomide is the generic ingredient in two branded drugs marketed by Rising Pharms Inc, Idt Australia Ltd, Mylan Pharms Inc, Accord Hlthcare, Merck Sharp Dohme, Chemi Spa, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in twenty-three countries.

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

Summary for Generic Name: temozolomide

Tradenames:2
Patents:4
Applicants:11
NDAs:12
Drug Master File Entries: see list16
Suppliers / Packagers: see list14
Bulk Api Vendors: see list85
Clinical Trials: see list275
Patent Applications: see list7,011
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:temozolomide at DailyMed

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL201742-005Feb 12, 2014RXNoNo► Subscribe► Subscribe
Amerigen Pharms Ltd
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL203490-004Jul 13, 2016RXNoNo► Subscribe► Subscribe
Kremers Urban Pharms
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL203898-006Feb 10, 2016RXNoNo► Subscribe► Subscribe
Sun Pharma Global
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL201742-006Feb 12, 2014RXNoNo► Subscribe► Subscribe
Idt Australia Ltd
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL206413-003Apr 12, 2016RXNoNo► 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 Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 19995,260,291*PED► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 20065,260,291*PED► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-006Oct 19, 20065,260,291*PED► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277-001Feb 27, 20095,260,291*PED► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-004Aug 11, 19995,260,291*PED► 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
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents► Subscribe
7,674,790Processes of making and using 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
Japan4077794► Subscribe
Poland372319► Subscribe
World Intellectual Property Organization (WIPO)03072082► Subscribe
Slovenia1478339► Subscribe
Canada2476494► 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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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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