BOCEPREVIR - Generic Drug Details

What are the generic sources for boceprevir and what is the scope of freedom to operate?

Boceprevir is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Boceprevir has one hundred and ten patent family members in thirty-three countries.

Summary for BOCEPREVIR

International Patents:	110
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	72
Patent Applications:	3,649
DailyMed Link:	BOCEPREVIR at DailyMed

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

Dosage:

CAPSULE;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 BOCEPREVIR

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

Sponsor	Phase
Dayanand Medical College and Hospital
American Research Corporation	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 2/Phase 3

See all BOCEPREVIR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BOCEPREVIR

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 BOCEPREVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No			Y
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No			Y	Y
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No

Expired US Patents for BOCEPREVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011

EU/EMA Drug Approvals for BOCEPREVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Ltd	Victrelis	boceprevir	EMEA/H/C/002332 Victrelis is indicated for the treatment of chronic hepatitis-C (CHC) genotype-1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.	Withdrawn	no	no	no	2011-07-18

International Patents for BOCEPREVIR

Country	Patent Number	Title	Estimated Expiration
New Zealand	523782	Peptides as NS3-serine protease inhibitors of hepatitis C virus
Taiwan	200307691
Slovenia	1385870
Russian Federation	2004125279
Taiwan	I324611
World Intellectual Property Organization (WIPO)	2006130686
Cyprus	1112267

Supplementary Protection Certificates for BOCEPREVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1385870	C300506	Netherlands		PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROATMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	300506	Netherlands		PRODUCT NAME: BOCEPREVIR, OF EEN ENANTIOMEER, STEREOISIOMEER, ROTAMEER, TAUTOMEER OF RACEMAAT VAN DIE VERBINDING, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	410	Finland
1385870	C01385870/01	Switzerland		PRODUCT NAME: BOCEPREVIR; REGISTRATION NO/DATE: SWISSMEDIC 62105 31.10.2011
1385870	12C0002	France		PRODUCT NAME: BOCEPREVIR OU UN ENANTIOMERE, STEREOISOMERE, ROTAMERE, TAUTOMERE OU RACEMATE DUDIT COMPOSE, OU UN DE SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870	C 2011 014	Romania		PRODUCT NAME: BOCEPREVIR(1R,2S,5S)-N-[3-AMINO-1-(CICLOBUTILMETIL)-2,3-DIOXOPROPIL]-3-[(2S)-2[[[(1,1-DIMETILETIL)AMINO]CARBONIL]AMINO]-3,3-DIMETIL-1-OXOBUTIL]-6,6-DIMETIL-3-AZABICICLO[3.1.0]HEXAN-2-CARBOXAMIDA; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/704/001; DATE OF NATIONAL AUTHORISATION: 20110718; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/704/001; DATE OF FIRST AUTHORISATION IN EEA: 20110718
1385870	CA 2011 00036	Denmark		PRODUCT NAME: BOCEPREVIR ELLER EN ENANTIOMER, EN STEREOISOMER, EN ROTAMER, EN TAUTOMER ELLER ET RACEMAT AF DENNE FORBINDELSE, ELLER FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT AF DENNE FORBINDEL