VICTRELIS Drug Patent Profile

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Which patents cover Victrelis, and when can generic versions of Victrelis launch?

Victrelis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in VICTRELIS is boceprevir. Additional details are available on the boceprevir profile page.

DrugPatentWatch^® Generic Entry Outlook for Victrelis

Victrelis was eligible for patent challenges on May 13, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VICTRELIS

International Patents:	110
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	9
Patent Applications:	1,634
Formulation / Manufacturing:	see details
DailyMed Link:	VICTRELIS at DailyMed

Drug patent expirations by year for VICTRELIS

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

Generic Entry Date for VICTRELIS^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 202258 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 VICTRELIS

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

Sponsor	Phase
Hoffmann-La Roche
UMC Utrecht	Phase 2
Radboud University	Phase 2

See all VICTRELIS clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VICTRELIS

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 VICTRELIS

VICTRELIS is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VICTRELIS 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 VICTRELIS

Pharmaceutical formulations and methods of treatment using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE

Administration of HCV protease inhibitors in combination with food to improve bioavailability
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION, ADMINISTERED WITH FOOD

Peptides as NS3-serine protease inhibitors of hepatitis C virus
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH COMPENSATED LIVER DISEASE

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 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 VICTRELIS

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

EU/EMA Drug Approvals for VICTRELIS

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for VICTRELIS

When does loss-of-exclusivity occur for VICTRELIS?

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

Argentina

Patent: 5198
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 06252553
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0610737
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 11155
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1212970
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 19478
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 60415
Estimated Expiration: ⤷ Try a Trial

Patent: 08542383
Estimated Expiration: ⤷ Try a Trial

Patent: 12250996
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 07015270
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 3365
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 076613
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 070011
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 0709987
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 080021634
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 72980
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 28138
Estimated Expiration: ⤷ Try a Trial

Patent: 0716157
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 VICTRELIS around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006130628		⤷ Try a Trial
Brazil	0306931		⤷ Try a Trial
Luxembourg	91910		⤷ Try a Trial
Japan	2012250996	PHARMACEUTICAL FORMULATION AND METHOD OF TREATMENT USING THE SAME	⤷ Try a Trial
South Korea	20080021634	PHARMACEUTICAL FORMULATIONS AND METHODS OF TREATMENT USING THE SAME	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VICTRELIS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1385870	300506	Netherlands	⤷ Try a Trial	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	12C0002	France	⤷ Try a Trial	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	C300506	Netherlands	⤷ Try a Trial	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	CA 2011 00036	Denmark	⤷ Try a Trial	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
1385870	SPC/GB11/057	United Kingdom	⤷ Try a Trial	PRODUCT NAME: BOCEPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/704/001 20110720
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description