DrugPatentWatch Database Preview

TAFINLAR Drug Profile

« Back to Dashboard

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 three patent family members in thirty-nine countries.

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

Summary for TAFINLAR

International Patents:	103
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	24
Clinical Trials:	14
Patent Applications:	27
Drug Prices:	see details
DailyMed Link:	TAFINLAR at DailyMed

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	202806-002	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	202806-001	May 29, 2013		RX	Yes	No

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

International Patents for TAFINLAR

Country	Document Number	Estimated Expiration
Denmark	1761528
Spain	2397825
South Korea	20110013456
Japan	2012072155

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
00701	Netherlands		PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FRAMACEUTISCH 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,C1761528	Lithuania		PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630