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TAFINLAR Drug Profile

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When do Tafinlar patents expire, and what generic alternatives are available?

Tafinlar is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dabrafenib mesylate profile page.

Summary for TAFINLAR

International Patents:	107
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	75
Clinical Trials:	22
Patent Applications:	78
Drug Prices:	Drug price information for TAFINLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAFINLAR
DailyMed Link:	TAFINLAR at DailyMed

See drug prices for TAFINLAR

Generic Entry Opportunity Date for TAFINLAR

NDA:

202806

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 TAFINLAR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Novartis Pharmaceuticals	Phase 4
Universitair Ziekenhuis Brussel	Phase 2

See all TAFINLAR clinical trials

Recent Litigation for TAFINLAR

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Plexxikon Inc. v. Novartis Pharmaceuticals Corporation	2017-08-03

See all TAFINLAR litigation

Pharmacology for TAFINLAR

Drug Class

Kinase Inhibitor

Mechanism of Action

Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Breast Cancer Resistance Protein Inhibitors Protein Kinase Inhibitors Cytochrome P450 3A4 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2C19 Inducers Organic Anion Transporting Polypeptide 1B1 Inhibitors

Synonyms for TAFINLAR

(GSK2118436) pound notDabrafenib

1195765-45-7

4CA-0431

AB0087834

AB01565833_02

ABP001006

AC-25889

AKOS024463285

AKOS032950004

AOB87722

API01001

AS-19634

AX8262770

BC297817

BCP09341

BDBM50428286

Benzenesulfonamide, N-[3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluoro-

BFSMGDJOXZAERB-UHFFFAOYSA-N

BRD-K09951645-066-01-2

C23H20F3N5O2S2

CHEBI:75045

CHEMBL2028663

CS-0692

D10064

Dabrafenib

Dabrafenib (Free Base)

Dabrafenib (GSK2118436)

Dabrafenib (USAN)

Dabrafenib [USAN:INN]

Dabrafenib Mesylate (GSK-2118436)

DABRAFENIB, KB-57246

DB08912

DTXSID20152499

EX-A1320

FD5028

GSK 2118436

GSK 2118436A

GSK-2118436A

GSK2118436A

GTPL6494

HMS3656D12

HY-14660

J-004153

KB-01625

KB-57246

KS-000005OR

MLS006011052

MolPort-028-720-422

N-(3-(5-(2-aminopyrimidin-4-yl)-2-(tert-butyl)thiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide

N-(3-(5-(2-aminopyrimidin-4-yl)-2-tert-butylthiazol-4-yl)-2-fluorophenyl)-2,6-difluorobenzenesulfonamide

N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(tert-butyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluorobenzenesulfo

N-[3-[5-(2-Amino-4-pyrimidinyl)-2-(tert-butyl)-4-thiazolyl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide

N-[3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl]-2,6-difluorobenzenesulfonamide

N-{3-(5-(2-aminopyrimidin-4-yl)-2-(1,1-dimethylethyl)thiazol-4-yl)-2-fluorophenyl}-2,6- difluorobenzenesulfonamide

N-{3-[5-(2-amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide

N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butyl-1,3-thiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide

N-{3-[5-(2-aminopyrimidin-4-yl)-2-tert-butylthiazol-4-yl]-2-fluorophenyl}-2,6-difluorobenzenesulfonamide

NCGC00346716-01

NCGC00346716-14

P06

QCR-129

QGP4HA4G1B

S2807

SB13355

SCHEMBL806377

SMR004702844

SW219503-1

Tube719

UNII-QGP4HA4G1B

W-5688

Y1871

ZINC68153186

US Patents and Regulatory Information for TAFINLAR

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
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes			Y	Y

International Patents for TAFINLAR

Country	Patent Number	Estimated Expiration
Portugal	1761528
Croatia	P20160447
New Zealand	588970
Spain	2576684
South Korea	101628746

Supplementary Protection Certificates for TAFINLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	CA 2014 00055	Denmark		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	300701	Netherlands		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
1761528	C20140036 00120	Estonia		PRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
1761528	CR 2014 00055	Denmark		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 20140702
1761528	C01761528/01	Switzerland		PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016