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Generated: April 23, 2017

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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 patent protection?

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 four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: temozolomide

Drug Master File Entries: see list16
Suppliers / Packagers: see list15
Bulk Api Vendors: see list85
Clinical Trials: see list275
Patent Applications: see list7,039
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes6,987,108► SubscribeY ► Subscribe
Merck Sharp Dohme
CAPSULE;ORAL021029-003Aug 11, 1999ABRXYesNo► Subscribe► Subscribe
CAPSULE;ORAL078879-002Mar 1, 2010ABRXNoNo► Subscribe► Subscribe
Kremers Urban Pharms
CAPSULE;ORAL203898-004Feb 10, 2016ABRXNoNo► Subscribe► Subscribe
Amneal Pharms
CAPSULE;ORAL203691-003May 8, 2015ABRXNoNo► Subscribe► Subscribe
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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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