BRAFTOVI Drug Patent Profile
✉ Email this page to a colleague
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
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 |


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
Sponsor | Phase |
---|---|
European Association of Dermato Oncology | Phase 2 |
UNICANCER | Phase 2 |
EADO - European Association of Dermato Oncology | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for BRAFTOVI
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
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 |