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Temsirolimus - Generic Drug Details

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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.

This ingredient has forty-three patent family members in twenty-eight countries.

There are five drug master file entries for temsirolimus. One supplier is listed for this compound.

Summary for Generic Name: temsirolimus

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
TORISEL
temsirolimus
SOLUTION;INTRAVENOUS022088-001May 30, 2007RXYes► subscribe► subscribe
Pf Prism Cv
TORISEL
temsirolimus
SOLUTION;INTRAVENOUS022088-001May 30, 2007RXYes8,722,700*PED► subscribeY► subscribe
Pf Prism Cv
TORISEL
temsirolimus
SOLUTION;INTRAVENOUS022088-001May 30, 2007RXYes8,026,276*PED► subscribeY► subscribe
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International Patent Family for Ingredient: temsirolimus

Country Document Number Estimated Expiration
Slovakia133096► subscribe
Brazil9507323► subscribe
HungaryT77410► 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
C/GB08/025United Kingdom► subscribePRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119
C017/2008Ireland► subscribeSPC017/2008: 20090911, EXPIRES: 20200413
438Luxembourg► subscribe91438, EXPIRES: 20200414
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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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