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Last Updated: February 18, 2020

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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 and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and sixteen patent family members in forty-three 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.

US ANDA Litigation and Generic Entry Outlook for Tafinlar

Tafinlar was eligible for patent challenges on May 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TAFINLAR
Drug Prices for TAFINLAR

See drug prices 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.

Recent Clinical Trials for TAFINLAR

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
Novartis PharmaceuticalsPhase 4

See all TAFINLAR clinical trials

Recent Litigation for TAFINLAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Plexxikon Inc. v. Novartis Pharmaceuticals Corporation2017-08-03

See all TAFINLAR litigation

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 TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 C300701 Netherlands   Start Trial 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
1761528 PA2014039,C1761528 Lithuania   Start Trial PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 132014902315090 Italy   Start Trial PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Dow
AstraZeneca
Express Scripts
Colorcon
Harvard Business School

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.