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Last Updated: March 19, 2024

INCIVEK Drug Patent Profile


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DrugPatentWatch® 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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  Try a Trial

Summary for INCIVEK
Drug patent expirations by year for INCIVEK
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Timothy Morgan, MDPhase 2/Phase 3
Vertex Pharmaceuticals IncorporatedPhase 2/Phase 3
Santaris Pharma A/SPhase 2

See all INCIVEK clinical trials

US Patents and Regulatory Information for INCIVEK

INCIVEK is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INCIVEK is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INCIVEK

Peptidomimetic protease inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Dose forms
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC HEPATITIS C

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vertex Pharms INCIVEK telaprevir TABLET;ORAL 201917-001 May 23, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a 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
⤷  Try a Trial INCIVEK ⤷  Try a Trial

EU/EMA Drug Approvals for INCIVEK

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International N.V. Incivo telaprevir EMEA/H/C/002313
Incivo, in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype-1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis):who are treatment naïve;who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.
Withdrawn no no no 2011-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INCIVEK

When does loss-of-exclusivity occur for INCIVEK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05302361
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 85647
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1068547
Estimated Expiration: ⤷  Try a Trial

Patent: 2988365
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19336
Estimated Expiration: ⤷  Try a Trial

Patent: 00021
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 08518943
Estimated Expiration: ⤷  Try a Trial

Patent: 13060474
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 1025
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07005179
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 072733
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 93863
Estimated Expiration: ⤷  Try a Trial

Patent: 07119725
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 070085547
Estimated Expiration: ⤷  Try a Trial

Patent: 130063022
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 37990
Estimated Expiration: ⤷  Try a Trial

Patent: 0630093
Estimated Expiration: ⤷  Try a Trial

Patent: 1424733
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INCIVEK around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1114090 ⤷  Try a Trial
South Korea 20100043293 ⤷  Try a Trial
El Salvador 2003000617 INHIBIDORES DE LA PROTEASA PEPTIDOMIMETICA REF. X-14912M ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INCIVEK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1320540 CR 2012 00007 Denmark ⤷  Try a 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 C01320540/01 Switzerland ⤷  Try a Trial FORMER OWNER: VERTEX PHARMACEUTICALS INCORPORATED, US
1320540 2012/009 Ireland ⤷  Try a Trial PRODUCT NAME: TELAPREVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT AND/OR SOLVATE THEREOF OR SOLVATES OF SUCH SALTS; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.