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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Covington
Express Scripts
Citi
Chubb
Deloitte
Cantor Fitzgerald
Cipla
US Army
Fuji

Generated: December 11, 2017

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Temsirolimus - Generic Drug Details

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What are the generic sources for temsirolimus and what is the scope of temsirolimus patent protection?

Temsirolimus
is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Temsirolimus has forty-eight patent family members in twenty-eight countries and ten supplementary protection certificates in eight countries.

There are five drug master file entries for temsirolimus. One supplier is listed for this compound.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Pf Prism CvTORISELtemsirolimusSOLUTION;INTRAVENOUS022088-001May 30, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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International Patent Family for Ingredient: temsirolimus

Country Document Number Estimated Expiration
European Patent Office1760083► Subscribe
Hungary225915► Subscribe
Austria234307► Subscribe
Portugal1266899► Subscribe
China1149296► Subscribe
Australia679854► Subscribe
Czech Republic9603052► Subscribe
Russian Federation2134267► Subscribe
Austria537176► Subscribe
Poland183178► 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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Supplementary Protection Certificates for Tradename: TEMSIROLIMUS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008 00028Denmark► Subscribe
00348Netherlands► SubscribePRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
C0018France► SubscribePRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
2008009,C0763039Lithuania► SubscribePRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119
2008009Lithuania► SubscribePRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119
C017/2008Ireland► SubscribeSPC017/2008: 20090911, EXPIRES: 20200413
C/GB08/025United Kingdom► SubscribePRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
438Luxembourg► Subscribe91438, EXPIRES: 20200414
0348Netherlands► Subscribe300348, 20150414, EXPIRES: 20200413
0763039/01Switzerland► SubscribePRODUCT NAME: TEMSIROLIMUS; REGISTRATION NUMBER/DATE: SWISSMEDIC 58100 12.12.2008
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Serving leading biopharmaceutical companies globally:

US Department of Justice
McKesson
Teva
Chubb
QuintilesIMS
Farmers Insurance
Medtronic
Argus Health
McKinsey
Cerilliant

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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