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Last Updated: September 25, 2022

ZELBORAF Drug Patent 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-nine 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

See drug prices for ZELBORAF

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
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2
Shanghai Kechow Pharma, Inc.Phase 2

See all ZELBORAF clinical trials

US Patents and Regulatory Information for ZELBORAF

ZELBORAF is protected by seven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZELBORAF is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 ZELBORAF

Compounds and methods for development of Ret modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for kinase modulation, and indications therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for kinase modulation, and indications therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and methods for kinase modulation, and indications therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ZELBORAF IS INDICATED FOR THE TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION

Compounds and methods for kinase modulation, and indications therefor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E MUTATION AS DETECTED BY AN FDA APPROVED TEST

Process for the manufacture of pharmaceutically active compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting ZELBORAF

TREATMENT OF PATIENTS WITH ERDHEIM-CHESTER DISEASE WITH BRAF V600 MUTATION
Exclusivity Expiration: See Plans and Pricing

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

EU/EMA Drug Approvals for ZELBORAF

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH Zelboraf vemurafenib EMEA/H/C/002409
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.
Authorised no no no 2012-02-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ZELBORAF

When does loss-of-exclusivity occur for ZELBORAF?

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

Argentina

Patent: 8033
Estimated Expiration: See Plans and Pricing

Patent: 1037
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10232670
Estimated Expiration: See Plans and Pricing

Patent: 10318049
Estimated Expiration: See Plans and Pricing

Patent: 15238857
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1008709
Estimated Expiration: See Plans and Pricing

Patent: 2012009609
Estimated Expiration: See Plans and Pricing

Patent: 2020005420
Estimated Expiration: See Plans and Pricing

Canada

Patent: 38573
Estimated Expiration: See Plans and Pricing

Patent: 78693
Estimated Expiration: See Plans and Pricing

China

Patent: 1761378
Estimated Expiration: See Plans and Pricing

Patent: 2361870
Estimated Expiration: See Plans and Pricing

Patent: 2596953
Estimated Expiration: See Plans and Pricing

Patent: 5237530
Estimated Expiration: See Plans and Pricing

Patent: 0269838
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 10296
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 110420
Estimated Expiration: See Plans and Pricing

Patent: 170089
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151156
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16983
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 14356
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 011000291
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 11011282
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 11004004
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2924
Estimated Expiration: See Plans and Pricing

Patent: 1116
Estimated Expiration: See Plans and Pricing

Patent: 1190098
Estimated Expiration: See Plans and Pricing

Patent: 1591240
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99559
Estimated Expiration: See Plans and Pricing

Patent: 14356
Estimated Expiration: See Plans and Pricing

Patent: 99138
Estimated Expiration: See Plans and Pricing

Patent: 55180
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2008061829
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 11002147
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 68590
Estimated Expiration: See Plans and Pricing

Patent: 17195
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27598
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4328
Estimated Expiration: See Plans and Pricing

Patent: 9108
Estimated Expiration: See Plans and Pricing

Patent: 1336
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11942
Estimated Expiration: See Plans and Pricing

Patent: 12522791
Estimated Expiration: See Plans and Pricing

Patent: 13510813
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 56
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0737
Estimated Expiration: See Plans and Pricing

Patent: 2424
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9923
Estimated Expiration: See Plans and Pricing

Patent: 11008303
Estimated Expiration: See Plans and Pricing

Patent: 12005224
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 028
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4398
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1100161
Estimated Expiration: See Plans and Pricing

Peru

Patent: 120876
Estimated Expiration: See Plans and Pricing

Poland

Patent: 14356
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 14356
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 12123958
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500302
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3178
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 14356
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1202937
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1739994
Estimated Expiration: See Plans and Pricing

Patent: 120006006
Estimated Expiration: See Plans and Pricing

Patent: 120101439
Estimated Expiration: See Plans and Pricing

Patent: 170058465
Estimated Expiration: See Plans and Pricing

Spain

Patent: 52386
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 04719
Estimated Expiration: See Plans and Pricing

Patent: 1040179
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 11000436
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8842
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 540
Estimated Expiration: See Plans and Pricing

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 ZELBORAF around the world.

Country Patent Number Title Estimated Expiration
Hungary E027370 See Plans and Pricing
Malaysia 147410 COMPOUNDS AND METHODS FOR KINASE MODULATION, AND INDICATIONS THEREFOR See Plans and Pricing
Taiwan I432193 See Plans and Pricing
Japan 5934742 See Plans and Pricing
South Korea 20080030619 PYRROLO[2,3-B]PYRIDINE DERIVATIVES AS PROTEIN KINASE INHIBITORS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZELBORAF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1893612 2012/025 Ireland See Plans and Pricing PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
1893612 CA 2012 00028 Denmark See Plans and Pricing
1893612 SPC/GB12/021 United Kingdom See Plans and Pricing PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
1893612 122, 5012-2012 Slovakia See Plans and Pricing PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: EI/1/712/751/002 20120217
1893612 122012000043 Germany See Plans and Pricing PRODUCT NAME: VEMURAFENIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.