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Telaprevir - Generic Drug Details

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Telaprevir is the generic ingredient in one branded drug marketed by Vertex Pharms and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventeen patent family members in thirty-six countries.

There are three drug master file entries for telaprevir.

Summary for Generic Name: telaprevir

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list3
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
Vertex Pharms
INCIVEK
telaprevir
TABLET;ORAL201917-001May 23, 2011DISCNNo► subscribe► subscribe
Vertex Pharms
INCIVEK
telaprevir
TABLET;ORAL201917-001May 23, 2011DISCNNo8,529,882► subscribe ► subscribe
Vertex Pharms
INCIVEK
telaprevir
TABLET;ORAL201917-001May 23, 2011DISCNNo7,820,671► subscribeYY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: telaprevir

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
8,252,923Peptidomimetic protease inhibitors► 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: telaprevir

Country Document Number Estimated Expiration
Hong Kong1114090► subscribe
Japan2012197289► subscribe
China1451014► 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: TELAPREVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00007Denmark► subscribePRODUCT NAME: TELAPREVIR OG FARMACEUTISK ACCEPTABLE SALTE OG/ELLER SOLVATER AF TELAPREVIR ELLER SOLVATER AF SADANNE SALTE; REG. NO/DATE: EU/1/11/720/001 20110919
C/GB12/010United Kingdom► subscribePRODUCT NAME: TELAPREVIR OR PHARMACEUTICALLY ACCEPTABLE SALTS AND/OR SOLVATES OF TELAPREVIR OR SOLVATES OF SUCH SALTS.; REGISTERED: UK EU/1/11/720/001 20110919
90007-2Sweden► subscribePRODUCT NAME: TELAPREVIR OCH FARMACEUTISKT GODTAGBARA SALTER OCH/ELLER SOLVAT AV TELAPREVIR ELLER SOLVAT AV SADANA SALTER; REG. NO/DATE: EU/1/11/720/001 20110919
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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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