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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BRAFTOVI

Generic Entry Date for BRAFTOVI^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing NDA: 210496 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

Sponsor	Phase
European Association of Dermato Oncology	Phase 2
UNICANCER	Phase 2
EADO - European Association of Dermato Oncology	Phase 2

See all BRAFTOVI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRAFTOVI

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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 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

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: 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

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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
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

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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.

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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

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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