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Last Updated: November 25, 2020

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VICTRELIS Drug 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.

US ANDA Litigation and 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
Bulk Api Vendors: 43
Clinical Trials: 9
Patent Applications: 67
Formulation / Manufacturing:see details
DailyMed Link:VICTRELIS at DailyMed
Drug patent expirations by year for VICTRELIS
Generic Entry Opportunity Date for VICTRELIS
Generic Entry Date for VICTRELIS*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Hoffmann-La RocheN/A
UMC UtrechtPhase 2
Maastricht University Medical CenterPhase 2

See all VICTRELIS clinical trials

US Patents and Regulatory Information for VICTRELIS

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

Supplementary Protection Certificates for VICTRELIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1385870 2011/038 Ireland   Start Trial PRODUCT NAME: BOCEPREVIR OR AN ENANTIOMER, STEREOISOMER, ROTAMER, TAUTOMER OR RACEMATE OF SAID COMPOUND OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE OF SAID COMPOUND; REGISTRATION NO/DATE: EU/1/11/704/001 20110718
1385870 91910 Luxembourg   Start Trial 91910, EXPIRES: 20260718
1385870 CA 2011 00036 Denmark   Start 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 C 2011 014 Romania   Start Trial 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 300506 Netherlands   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
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McKinsey
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.