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Generated: October 18, 2018

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Dabrafenib mesylate - Generic Drug Details

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What are the generic sources for dabrafenib mesylate and what is the scope of dabrafenib mesylate patent protection?

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

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

Summary for dabrafenib mesylate
Synonyms for dabrafenib mesylate
1195768-06-9
AK174048
AKOS025396661
AOB87316
API0024336
AS-17010
B6DC89I63E
CHEBI:75048
CHEMBL2105729
CS-1641
D10104
Dabrafenib (Mesylate)
Dabrafenib mesilate (JAN)
Dabrafenib Mesylate (GSK-2118436)
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
MFCD20922872
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 Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for dabrafenib mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/063 Ireland ➤ Try a Free Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702
2014039,C1761528 Lithuania ➤ Try a Free Trial PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
2014039 Lithuania ➤ Try a Free Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
90063-3 Sweden ➤ Try a Free Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
5 5032-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
2014 00055 Denmark ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Accenture
Moodys
Queensland Health
McKesson
Julphar
UBS
Colorcon

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