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Last Updated: August 14, 2020

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INCIVEK Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Incivek

Incivek was eligible for patent challenges on May 23, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for INCIVEK
International Patents:125
US Patents:3
Applicants:1
NDAs:1
Bulk Api Vendors: 63
Clinical Trials: 11
Patent Applications: 137
Formulation / Manufacturing:see details
DailyMed Link:INCIVEK at DailyMed
Drug patent expirations by year for INCIVEK
Generic Entry Opportunity Date for INCIVEK
Generic Entry Date for INCIVEK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INCIVEK

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

SponsorPhase
Vertex Pharmaceuticals IncorporatedPhase 2/Phase 3
Timothy Morgan, MDPhase 2/Phase 3
Santaris Pharma A/SPhase 2

See all INCIVEK clinical trials

US Patents and Regulatory Information for INCIVEK

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

Premature patent expiration for: INCIVEK

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
  Start Trial INCIVEK   Start Trial
  Start Trial INCIVEK   Start Trial

Supplementary Protection Certificates for INCIVEK

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
1320540 CR 2012 00007 Denmark   Start Trial PRODUCT 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
1320540 PA2012003 Lithuania   Start Trial PRODUCT NAME: TELAPREVIRUM; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
1320540 12C0018 France   Start Trial PRODUCT NAME: TELAPREVIR ET LES SELS ET/OU LES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES DU TELAPREVIR OU LES SOLVATES DE TELS SELS; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
1320540 122012000015 Germany   Start Trial PRODUCT NAME: TELAPREVIR UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE PHARMAZEUTISCH VERTRAEGLICHE SALZE UND/ODER SOLVATE VON TELAPREVIR ODER SOLVATE SOLCHER SALZE.; 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:

McKinsey
Moodys
Harvard Business School
Express Scripts
Baxter
McKesson

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 verification 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.