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Last Updated: January 28, 2020

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Dabrafenib mesylate - Generic Drug Details

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What are the generic drug sources for dabrafenib mesylate and what is the scope of freedom to operate?

Dabrafenib mesylate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dabrafenib mesylate has one hundred and sixteen patent family members in forty-three countries.

There is one drug master file entry for dabrafenib mesylate. One supplier is listed for this compound.

Recent Clinical Trials for dabrafenib mesylate

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SponsorPhase
National Cancer Institute (NCI)Phase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
Yonsei UniversityPhase 2

See all dabrafenib mesylate clinical trials

Recent Litigation for dabrafenib mesylate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Plexxikon Inc. v. Novartis Pharmaceuticals Corporation2017-08-03

See all dabrafenib mesylate litigation

Synonyms for dabrafenib mesylate
1195768-06-9
AK174048
AKOS025396661
AOB87316
API0024336
AS-17010
B6DC89I63E
BCP04738
CHEBI:75048
CHEMBL2105729
CS-1641
D10104
Dabrafenib (Mesylate)
Dabrafenib mesilate (JAN)
Dabrafenib Mesylate (GSK-2118436B)
Dabrafenib mesylate (USAN)
Dabrafenib mesylate [USAN]
Dabrafenib Mesylate(GSK-2118436B)
Dabrafenib methanesulfonate
dabrafenib monomesylate
DTXSID70152500
EX-A1559
FT-0696677
GSK 2118436 Mesylate
GSK 2118436B
GSK-2118436A
GSK-2118436B
GSK2118436 Mesylate
GSK2118436 Methane sulfonate salt
GSK2118436 Ms salt, Dabrafenib Ms salt, GSK2118436A Ms salt
GSK2118436B
HY-14660A
KS-00000T33
METHANE SULFONATE SALT
MolPort-039-136-624
N-(3-(5-(2-aminopyrimidin-4-yl)-2-(tert-butyl)thiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide methanesulfonate
N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide methanesulfonate
N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide methanesulfonate
SC-14698
SCHEMBL1127269
SR-01000941590
SR-01000941590-1
Tafinlar (TN)
Taflinar
UNII-B6DC89I63E
YKGMKSIHIVVYKY-UHFFFAOYSA-N

US Patents and Regulatory Information for dabrafenib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   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 dabrafenib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 C20140036 00120 Estonia   Start Trial PRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
1761528 CA 2014 00055 Denmark   Start Trial PRODUCT NAME: TRAMETINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, HYDRAT ELLER SOLVAT DERAF, HERUNDER TRAMETINIBDIMETHYLSULFOXID; REG. NO/DATE: EU/1/14/931/01-06 20140630
1761528 68/2014 Austria   Start Trial PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
>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 verifification 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.