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 and one Paragraph IV challenge.
This drug has one hundred and eighty-nine 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.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for BRAFTOVI
| International Patents: | 189 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 17 |
| Patent Applications: | 932 |
| Drug Prices: | Drug price information for BRAFTOVI |
| What excipients (inactive ingredients) are in BRAFTOVI? | BRAFTOVI excipients list |
| DailyMed Link: | BRAFTOVI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| National Cancer Institute (NCI) | Phase 2/Phase 3 |
| Alliance for Clinical Trials in Oncology | Phase 2/Phase 3 |
| Belgian Group of Digestive Oncology | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BRAFTOVI
Paragraph IV (Patent) Challenges for BRAFTOVI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| BRAFTOVI | Capsules | encorafenib | 75 mg | 210496 | 3 | 2022-06-27 |
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA
3,4-diarylpyrazoles as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-.alpha. inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MELANOMA WITH A BRAF MUTATION
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Array Biopharma Inc | BRAFTOVI | encorafenib | CAPSULE;ORAL | 210496-002 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 mutation, in 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: ⤷ Try a Trial
Australia
Patent: 13299841
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015002384
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 79548
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 15000294
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4519887
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 00273
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0190537
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 15008695
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 8420
Estimated Expiration: ⤷ Try a Trial
Patent: 1590332
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
Patent: 74904
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1500025
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 04976
Estimated Expiration: ⤷ Try a Trial
Patent: 11831
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 42877
Estimated Expiration: ⤷ Try a Trial
India
Patent: 0DEN2015
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6934
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 42396
Estimated Expiration: ⤷ Try a Trial
Patent: 95024
Estimated Expiration: ⤷ Try a Trial
Patent: 74669
Estimated Expiration: ⤷ Try a Trial
Patent: 15524472
Estimated Expiration: ⤷ Try a Trial
Patent: 18109022
Estimated Expiration: ⤷ Try a Trial
Patent: 20019780
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 0130236
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 9403
Estimated Expiration: ⤷ Try a Trial
Patent: 15001732
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 829
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 3940
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 150673
Estimated Expiration: ⤷ Try a Trial
Patent: 191655
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 015500246
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 734
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201500321Y
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 82440
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2112885
Estimated Expiration: ⤷ Try a Trial
Patent: 150040905
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 17911
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 07754
Estimated Expiration: ⤷ Try a Trial
Patent: 1410247
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 15000027
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1904980
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 5786
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Croatia | P20190537 | ⤷ Try a Trial | |
| Spain | 2717911 | ⤷ Try a Trial | |
| New Zealand | 703940 | Pharmaceutical combinations comprising a b-raf inhibitor, an egfr inhibitor and optionally a pi3k-alpha inhibitor | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRAFTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | 300973 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924 |
| 2727918 | 122019000023 | Germany | ⤷ Try a Trial | |
| 2470526 | PA2019005,C2470526 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920 |
| >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.
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