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Last Updated: June 24, 2021

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ZELBORAF Drug Profile


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

Zelboraf is a drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and ninety-two patent family members in forty-six countries.

The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.

DrugPatentWatch® Generic Entry Outlook for Zelboraf

Zelboraf was eligible for patent challenges on August 17, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 6, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ZELBORAF
Drug patent expirations by year for ZELBORAF
Drug Prices for ZELBORAF

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZELBORAF
Generic Entry Date for ZELBORAF*:
Constraining patent/regulatory exclusivity:
NDA:
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 ZELBORAF

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

SponsorPhase
Fondazione Melanoma OnlusPhase 2
Clinical Research Technology S.r.l.Phase 2
Sun Yat-sen UniversityPhase 1/Phase 2

See all ZELBORAF clinical trials

US Patents and Regulatory Information for ZELBORAF

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Hoffmann La Roche ZELBORAF vemurafenib TABLET;ORAL 202429-001 Aug 17, 2011 RX Yes Yes   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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 ZELBORAF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 122, 5012-2012 Slovakia   Try Before You Buy PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612 C01893612/01 Switzerland   Try Before You Buy PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011
1893612 C 2012 020 Romania   Try Before You Buy PRODUCT NAME: VEMURAFENIB SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20120217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20120217
1893612 2012C/028 Belgium   Try Before You Buy PRODUCT NAME: VERMURAFENIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/751/001 20120221
1893612 462 Finland   Try Before You Buy
1893612 122 5012-2012 Slovakia   Try Before You Buy FIRST REGISTRATION NO/DATE: EU/1/12/751/001, 20120217
1893612 1290026-2 Sweden   Try Before You Buy PRODUCT NAME: VEMURAFENIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/751/001 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Colorcon
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Moodys

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.