INCIVEK Drug Patent Profile

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:	1,781
DailyMed Link:	INCIVEK at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INCIVEK

NDA:

201917

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
Vertex Pharmaceuticals Incorporated	Phase 2/Phase 3
Timothy Morgan, MD	Phase 2/Phase 3
Santaris Pharma A/S	Phase 2

See all INCIVEK clinical trials

US Patents and Regulatory Information for INCIVEK

INCIVEK is protected by two US patents.

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

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

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

Premature patent expiration for: INCIVEK

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	INCIVEK

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

International Patents for INCIVEK

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

Country	Patent Number	Title	Estimated Expiration
Canada	2697205	INHIBITEURS PEPTIDOMIMETIQUES DE PROTEASE (PEPTIDOMIMETIC PROTEASE INHIBITORS)
European Patent Office	1849797
World Intellectual Property Organization (WIPO)	0218369
South Korea	20080104383
European Patent Office	2368901
European Patent Office	1958956	Inhibiteurs de prothèse peptidominétique (Peptidomimetic protease inhibitors)
Peru	20020474	COMPUESTOS PEPTIDOMIMETICOS COMO INHIBIDORES DE LA SERINA PROTEASA NS3 DEL VIRUS DE HEPATITIS C

Supplementary Protection Certificates for INCIVEK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1320540	CR 2012 00007	Denmark		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		FORMER OWNER: VERTEX PHARMACEUTICALS INCORPORATED, US
1320540	1290007-2	Sweden		PRODUCT 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
1320540	2012/009	Ireland		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
1320540	PA2012003,C1320540	Lithuania		PRODUCT NAME: TELAPREVIRUM; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
1320540	PA2012003	Lithuania		PRODUCT NAME: TELAPREVIRUM; REGISTRATION NO/DATE: EU/1/11/720/001 20110919
1320540	132012902033336	Italy		PRODUCT NAME: TELAPREVIR(TELAPREVIR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/720/001, 20110919