Telaprevir - Generic Drug Details

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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for telaprevir.

Summary for telaprevir

International Patents:	124
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	103
Patent Applications:	3,978
DailyMed Link:	telaprevir at DailyMed

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

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 telaprevir

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
National Taiwan University Hospital	Phase 4
Dayanand Medical College and Hospital

See all telaprevir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for telaprevir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Expired US Patents for telaprevir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vertex Pharms	INCIVEK	telaprevir	TABLET;ORAL	201917-001	May 23, 2011

EU/EMA Drug Approvals for telaprevir

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 telaprevir

Country	Patent Number	Title	Estimated Expiration
Norway	329929
Taiwan	I359144
Taiwan	201022243
Slovenia	1320540

Supplementary Protection Certificates for telaprevir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1320540	122012000015	Germany		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
1320540	470	Finland
1320540	C 2012 005	Romania		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	132012902033336	Italy		PRODUCT NAME: TELAPREVIR(TELAPREVIR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/720/001, 20110919