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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
McKinsey
Moodys
Teva
AstraZeneca
Cipla
US Department of Justice
Fuji

Generated: August 20, 2018

DrugPatentWatch Database Preview

Dabrafenib mesylate - Generic Drug Details

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

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.

Dabrafenib mesylate has one hundred and three patent family members in thirty-nine countries.

There is one drug master file entry for dabrafenib mesylate. Two suppliers are listed for this compound.

Summary for dabrafenib mesylate
International Patents:103
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 2
Bulk Api Vendors: 31
Clinical Trials: 3
Patent Applications: 37
DailyMed Link:dabrafenib mesylate at DailyMed
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for dabrafenib mesylate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,378,423 Pyrimidine compound and medical use thereof ➤ Sign Up
8,642,759 Benzene sulfonamide thiazole and oxazole compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for dabrafenib mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/063 Ireland ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
2014039 Lithuania ➤ Sign Up PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
0701 Netherlands ➤ Sign Up PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Baxter
McKinsey
Teva
Federal Trade Commission
US Army
Merck
Deloitte

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