INCIVEK Drug Patent Profile
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When do Incivek patents expire, and what generic alternatives are available?
Incivek is a drug marketed by Vertex Pharms and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and twenty-four patent family members in thirty-eight countries.
The generic ingredient in INCIVEK is telaprevir. There are three drug master file entries for this compound. Additional details are available on the telaprevir profile page.
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
Summary for INCIVEK
International Patents: | 124 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 85 |
Clinical Trials: | 12 |
Patent Applications: | 2,131 |
Formulation / Manufacturing: | see details |
DailyMed Link: | INCIVEK at DailyMed |
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
Sponsor | Phase |
---|---|
Timothy Morgan, MD | Phase 2/Phase 3 |
Vertex Pharmaceuticals Incorporated | Phase 2/Phase 3 |
Santaris Pharma A/S | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for INCIVEK
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 |
Expired US Patents for INCIVEK
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vertex Pharms | INCIVEK | telaprevir | TABLET;ORAL | 201917-001 | May 23, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |