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Last Updated: August 14, 2020

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Telaprevir - Generic Drug Details

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

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.

Telaprevir has one hundred and twenty-five patent family members in thirty-eight countries.

There are three drug master file entries for telaprevir.

Summary for telaprevir
International Patents:125
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 3
Bulk Api Vendors: 62
Clinical Trials: 101
Patent Applications: 160
Formulation / Manufacturing:see details
DailyMed Link:telaprevir at DailyMed
Recent Clinical Trials for telaprevir

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AbbViePhase 4
National Taiwan University HospitalPhase 4
Dayanand Medical College and HospitalN/A

See all telaprevir clinical trials

US Patents and Regulatory Information for telaprevir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vertex Pharms INCIVEK telaprevir TABLET;ORAL 201917-001 May 23, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Vertex Pharms INCIVEK telaprevir TABLET;ORAL 201917-001 May 23, 2011 DISCN No No   Start Trial   Start Trial Y Y   Start Trial
Vertex Pharms INCIVEK telaprevir TABLET;ORAL 201917-001 May 23, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for telaprevir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1320540 C 2012 005 Romania   Start Trial PRODUCT NAME: TELAPREVIR SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTUIA, PRECUM SARURI SI/SAU SOLVATI ACCEPTABILI FARMACEUTIC SAU SOLVATI AI UNOR ASTFEL DE SARURI; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/720/001; DATE OF NATIONAL AUTHORISATION: 20110919; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/720/001; DATE OF FIRST AUTHORISATION IN EEA: 20110919
1320540 91960 Luxembourg   Start Trial 91960, EXPIRES: 20260831
1320540 PA2012003,C1320540 Lithuania   Start Trial PRODUCT NAME: TELAPREVIRUM; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
McKesson
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim

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