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Last Updated: April 5, 2020

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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 eleven patents protecting this drug.

This drug has one hundred and thirty-one patent family members in forty-nine countries.

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

US ANDA Litigation and 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 November 21, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BRAFTOVI
Drug patent expirations by year for BRAFTOVI
Drug Prices for BRAFTOVI

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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
ECOG-ACRIN Cancer Research GroupPhase 2
University of California, San FranciscoPhase 1/Phase 2
EADO - European Association of Dermato OncologyPhase 2

See all BRAFTOVI clinical trials

Synonyms for BRAFTOVI
1269440-17-6
8L7891MRB6
A13226
AC-30230
AS-35201
BCP08458
BDBM221688
Braftovi (TN)
Carbamic acid, N-[(1S)-2-[[4-[3-[5-chloro-2-fluoro-3-[(methylsulfonyl)amino]phenyl]-1-(1-methylethyl)-1H-pyrazol-4-yl]-2-pyrimidinyl]amino]-1-methylethyl]-, methyl ester
CHEMBL3301612
CMJCXYNUCSMDBY-ZDUSSCGKSA-N
CS-2289
D11053
DB11718
DTXSID00155347
Encorafenib
Encorafenib (JAN/USAN/INN)
Encorafenib (LGX818)
Encorafenib [USAN:INN]
EX-A1587
GTPL7908
HY-15605
LGX 818
LGX-818
LGX-818(Encorafenib)
LGX818
Methyl N-[(2S)-1-({4-[3-(5-chloro-2-fluoro-3-methanesulfonamidophenyl)-1-(propan-2-yl)-1H-pyrazol-4-yl]pyrimidin-2-yl}amino)propan-2-yl]carbamate
methyl N-[(2S)-1-[[4-[3-[5-chloro-2-fluoro-3-(methanesulfonamido)phenyl]-1-propan-2-ylpyrazol-4-yl]pyrimidin-2-yl]amino]propan-2-yl]carbamate
MFCD25976758
NCGC00378599-03
NVP-LGX818
NVP-LGX818-NXA
s7108
SB16926
SCHEMBL8228295
UNII-8L7891MRB6
US9314464, 9
ZINC68249103

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 210496-001 Jun 27, 2018 DISCN Yes No   Start Trial   Start Trial   Start Trial
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-002 Jun 27, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Array Biopharma Inc BRAFTOVI encorafenib CAPSULE;ORAL 210496-001 Jun 27, 2018 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>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 2019C/508 Belgium   Start Trial PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
2470526 1990012-5 Sweden   Start Trial PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2470526 122019000021 Germany   Start Trial PRODUCT NAME: ENCORAFENIB IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/18/1314 20180920
2470526 CA 2019 00012 Denmark   Start Trial PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. 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.