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Last Updated: June 28, 2022

BRAFTOVI Drug Patent Profile


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Which patents cover Braftovi, and what generic alternatives are available?

Braftovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and eighty-eight patent family members in fifty-three countries.

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

DrugPatentWatch® Generic Entry Outlook for Braftovi

Braftovi was eligible for patent challenges on June 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 5, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BRAFTOVI
International Patents:188
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 14
Patent Applications: 764
Drug Prices: Drug price information for BRAFTOVI
What excipients (inactive ingredients) are in BRAFTOVI?BRAFTOVI excipients list
DailyMed Link:BRAFTOVI at DailyMed
Drug patent expirations by year for BRAFTOVI
Drug Prices for BRAFTOVI

See drug prices for BRAFTOVI

DrugPatentWatch® Estimated Generic Entry Opportunity Date for BRAFTOVI
Generic Entry Date for BRAFTOVI*:
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 BRAFTOVI

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

SponsorPhase
European Association of Dermato OncologyPhase 2
UNICANCERPhase 2
EADO - European Association of Dermato OncologyPhase 2

See all BRAFTOVI clinical trials

US Patents and Regulatory Information for BRAFTOVI

BRAFTOVI is protected by twenty-one US patents and three FDA Regulatory Exclusivities.

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

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST

Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA

3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST

3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST

Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-- pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INDICATED IN COMBINATION WITH BINIMETINIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA WITH A BRAF MUTATION

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY

Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST

FDA Regulatory Exclusivity protecting BRAFTOVI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

ENCORAFENIB, IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULTPATIENTS WITH METASTATIC COLORECTAL CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
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
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-001 Jun 27, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 BRAFTOVI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pierre Fabre Medicament Braftovi encorafenib EMEA/H/C/004580
Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy
Authorised no no no 2018-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for BRAFTOVI

When does loss-of-exclusivity occur for BRAFTOVI?

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

Argentina

Patent: 2045
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13299841
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015002384
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79548
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15000294
Estimated Expiration: See Plans and Pricing

China

Patent: 4519887
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 00273
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0190537
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 82440
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 15008695
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8420
Estimated Expiration: See Plans and Pricing

Patent: 1590332
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 82440
Estimated Expiration: See Plans and Pricing

Patent: 74904
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1500025
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 04976
Estimated Expiration: See Plans and Pricing

Patent: 11831
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 42877
Estimated Expiration: See Plans and Pricing

India

Patent: 0DEN2015
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6934
Estimated Expiration: See Plans and Pricing

Japan

Patent: 42396
Estimated Expiration: See Plans and Pricing

Patent: 95024
Estimated Expiration: See Plans and Pricing

Patent: 74669
Estimated Expiration: See Plans and Pricing

Patent: 15524472
Estimated Expiration: See Plans and Pricing

Patent: 18109022
Estimated Expiration: See Plans and Pricing

Patent: 20019780
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 82440
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9403
Estimated Expiration: See Plans and Pricing

Patent: 15001732
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 829
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3940
Estimated Expiration: See Plans and Pricing

Peru

Patent: 150673
Estimated Expiration: See Plans and Pricing

Patent: 191655
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015500246
Estimated Expiration: See Plans and Pricing

Poland

Patent: 82440
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 82440
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 734
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201500321Y
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 82440
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2112885
Estimated Expiration: See Plans and Pricing

Patent: 150040905
Estimated Expiration: See Plans and Pricing

Spain

Patent: 17911
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 07754
Estimated Expiration: See Plans and Pricing

Patent: 1410247
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 15000027
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1904980
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5786
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 BRAFTOVI around the world.

Country Patent Number Title Estimated Expiration
Tunisia 2012000081 COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS See Plans and Pricing
Hungary E040370 See Plans and Pricing
Jordan 3493 صيغ صيدلانية (PHARMACEUTICAL FORMULATIONS) See Plans and Pricing
Guatemala 201200053 COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA See Plans and Pricing
Canada 2856406 FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRAFTOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 SPC/GB19/009 United Kingdom See Plans and Pricing PRODUCT NAME: ENCORAFENIB OR PHARMACEUTICALLY ACCEPTABLE SALTS OR SOLVATES THEREOF; REGISTERED: UK EU/1/18/1314/001-002 20180924; UK PLGB 00603/0240-0001 20180924; UK PLGB 00603/0241-0001 20180924
2470526 2019/012 Ireland See Plans and Pricing PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 CA 2019 00012 Denmark See Plans and Pricing PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924
2470526 CR 2019 00012 Denmark See Plans and Pricing PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
2470526 300973 Netherlands See Plans and Pricing PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
McKesson
Boehringer Ingelheim
Johnson and Johnson
Mallinckrodt

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.