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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cipla
Cantor Fitzgerald
Johnson and Johnson
Merck
Argus Health
UBS
Mallinckrodt
Baxter

Generated: July 21, 2018

DrugPatentWatch Database Preview

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 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: 31
Clinical Trials: 14
Patent Applications: 27
DailyMed Link:TAFINLAR at DailyMed
Drug patent expirations by year for TAFINLAR
Generic Entry Opportunity Date for TAFINLAR
Generic Entry Date for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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 ➤ 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
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ 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 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 ➤ Sign Up
7,378,423 Pyrimidine compound and medical use thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TAFINLAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014039 Lithuania ➤ Sign Up PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
2014039,C1761528 Lithuania ➤ Sign Up PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
90063-3 Sweden ➤ Sign Up PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
00701 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Queensland Health
Baxter
Harvard Business School
Julphar
Daiichi Sankyo
Chubb
Express Scripts
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.