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Last Updated: June 19, 2021

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BRAFTOVI Drug 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-two patent family members in fifty-one 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 will be eligible for patent challenges on June 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:182
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 9
Patent Applications: 591
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
Merck Sharp & Dohme Corp.Phase 3
PfizerPhase 3
Southwest Oncology GroupPhase 2

See all BRAFTOVI clinical trials

US Patents and Regulatory Information for BRAFTOVI

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   Get Started Free   Get Started Free Y Y   Get Started Free
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-001 Jun 27, 2018 DISCN Yes No   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-001 Jun 27, 2018 DISCN Yes No   Get Started Free   Get Started Free Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BRAFTOVI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2470526 19C1013 France   Get Started Free PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 C201930019 Spain   Get Started Free PRODUCT NAME: ENCORAFENIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1314; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1314; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526 7-2019 Slovakia   Get Started Free PRODUCT NAME: ENKORAFENIB; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2470526 C02470526/01 Switzerland   Get Started Free PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
2470526 1990012-5 Sweden   Get Started Free PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2727918 300975 Netherlands   Get Started Free PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; 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

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