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TAFINLAR Drug Profile

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Which patents cover Tafinlar, 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.

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

US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	31
Clinical Trials:	14
Patent Applications:	27
Drug Prices:	Drug price information for TAFINLAR
DailyMed Link:	TAFINLAR at DailyMed

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.

Pharmacology for TAFINLAR

Drug Class

Kinase Inhibitor

Mechanism of Action

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 Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Breast Cancer Resistance Protein Inhibitors

Synonyms for TAFINLAR

(GSK2118436) pound notDabrafenib

1195765-45-7

4CA-0431

AB0087834

AB01565833_02

ABP001006

AC-25889

AK160990

AKOS024463285

AKOS032950004

AOB87722

API01001

AS-19634

AX8262770

BC297817

BDBM50428286

BFSMGDJOXZAERB-UHFFFAOYSA-N

BRD-K09951645-066-01-2

C23H20F3N5O2S2

CHEBI:75045

CHEMBL2028663

CS-0692

D05ROI

D0BO9V

D10064

Dabrafenib

Dabrafenib (BRAF inhibitor)

Dabrafenib (Free Base)

Dabrafenib (GSK2118436)

Dabrafenib (USAN)

Dabrafenib [USAN:INN]

dabrafenib mesilate

Dabrafenib Mesylate (GSK-2118436)

DABRAFENIB, KB-57246

DB08912

DTXSID20152499

EX-A1320

FD5028

GSK 2118436

GSK 2118436A

GSK2118436A

GTPL6494

HE300679

HMS3656D12

HY-14660

J-004153

KB-01625

KB-57246

KS-000005OR

MFCD17215684

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

P06

QCR-129

QGP4HA4G1B

S2807

SCHEMBL806377

SMR004702844

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	202806-001	May 29, 2013		RX	Yes	No
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	202806-001	May 29, 2013		RX	Yes	No
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No

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Non-Orange Book US Patents for TAFINLAR

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
8,642,759	Benzene sulfonamide thiazole and oxazole compounds
7,378,423	Pyrimidine compound and medical use thereof

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International Patents for TAFINLAR

Country	Document Number	Estimated Expiration
New Zealand	552090
Canada	2775803
Cyprus	1113538
Japan	5718929
Eurasian Patent Organization	201290149

Supplementary Protection Certificates for TAFINLAR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0701	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
0140036 00120	Estonia		PRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
2014039	Lithuania		PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
C0083	France		PRODUCT NAME: TRAMETINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL,HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/931 20140630
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