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Temozolomide - Generic Drug Details

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Temozolomide is the generic ingredient in two branded drugs marketed by Lotus Pharm Co Ltd, Idt Australia Ltd, Mylan Pharms Inc, Merck Sharp Dohme, Sun Pharma Global, Barr, Amerigen Pharms Ltd, Amneal Pharms, and Kremers Urban Pharms, and is included in ten 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. Ten suppliers are listed for this compound.

Summary for Generic Name: temozolomide

Tradenames:2
Patents:3
Applicants:9
NDAs:10
Drug Master File Entries: see list16
Suppliers / Packaging: see list10
Formulation / Manufacturing:see details

Pharmacology for Ingredient: temozolomide

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

Clinical Trials for: temozolomide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL201742-003Feb 12, 2014RXNo<disabled><disabled>
Amneal Pharms
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL203691-003May 8, 2015RXNo<disabled><disabled>
Sun Pharma Global
TEMOZOLOMIDE
temozolomide
CAPSULE;ORAL201742-004Feb 12, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: temozolomide

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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<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 20065,260,291*PED<disabled>
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-003Aug 11, 19995,260,291*PED<disabled>
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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<disabled in preview>
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents<disabled in preview>
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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
Japan4785816<disabled in preview>
South Korea100970528<disabled in preview>
European Patent Office1938798<disabled in preview>
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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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