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Temozolomide - Generic Drug Details

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Temozolomide is the generic ingredient in two branded drugs marketed by Rising Pharms Inc, Idt Australia Ltd, Mylan Pharms Inc, Merck Sharp Dohme, Chemi Spa, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in eleven 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. Twelve suppliers are listed for this compound.

Summary for Generic Name: temozolomide

Tradenames:2
Patents:3
Applicants:10
NDAs:11
Drug Master File Entries: see list16
Suppliers / Packagers: see list12
Bulk Api Vendors: see list85
Clinical Trials: see list275
Patent Applications: see list10,513
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 1999RXNo► subscribe► subscribe
Chemi Spa
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL204639-004Nov 23, 2016RXNo► subscribe► subscribe
Idt Australia Ltd
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL206413-006Apr 12, 2016RXNo► 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;ORAL021029-005Oct 19, 20065,260,291*PED► subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-001Aug 11, 19995,260,291*PED► subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-002Aug 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
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
European Patent Office1478339► subscribe
China1635871► subscribe
Japan4785816► 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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