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Serving leading biopharmaceutical companies globally:

Novartis
Moodys
Queensland Health
Federal Trade Commission
Chinese Patent Office
UBS
McKinsey
Fish and Richardson
AstraZeneca
Covington

Generated: December 15, 2017

DrugPatentWatch Database Preview

TEMODAR Drug Profile

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When do Temodar patents expire, and what generic alternatives are available?

Temodar is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in twenty-three countries.

The generic ingredient in TEMODAR is temozolomide. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the temozolomide profile page.
Drug patent expirations by year for TEMODAR

Pharmacology for TEMODAR

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-001Aug 11, 1999ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-005Oct 19, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-002Aug 11, 1999ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-003Aug 11, 1999ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-004Aug 11, 1999ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-006Oct 19, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: TEMODAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-001Aug 11, 1999► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-004Aug 11, 1999► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-005Oct 19, 2006► Subscribe► Subscribe
Merck Sharp DohmeTEMODARtemozolomideCAPSULE;ORAL021029-006Oct 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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Paragraph IV (Patent) Challenges for TEMODAR

Drugname Dosage Strength RLD Submissiondate
temozolomideCapsules140 mg and 180 mgTemodar3/24/2008

Non-Orange Book Patents for Tradename: TEMODAR

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 Tradename: TEMODAR

Country Document Number Estimated Expiration
Cyprus1108291► Subscribe
Japan2005518434► Subscribe
China100346784► Subscribe
Japan4077794► Subscribe
Canada2476494► Subscribe
Argentina038535► Subscribe
Japan2008031186► Subscribe
European Patent Office1478339► Subscribe
Hong Kong1066466► Subscribe
Germany60321450► 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:

Citi
Fish and Richardson
Farmers Insurance
Covington
UBS
Medtronic
Johnson and Johnson
Express Scripts
Baxter
Merck

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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