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Last Updated: May 27, 2024

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TAFINLAR Drug Patent Profile


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Which patents cover Tafinlar, and what generic alternatives are available?

Tafinlar is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug.

This drug has one hundred and seventy-four patent family members in forty-five 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.

DrugPatentWatch® 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 April 15, 2031. 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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAFINLAR
Generic Entry Dates for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for TAFINLAR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, FOR SUSPENSION;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
Eva Marie Erfurth, MD, PhDPhase 2
Peter MacCallum Cancer Centre, AustraliaPhase 2
Austin HealthPhase 2

See all TAFINLAR clinical trials

US Patents and Regulatory Information for TAFINLAR

TAFINLAR is protected by eight US patents and thirteen FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TAFINLAR

Method of adjuvant cancer treatment
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrimidine compound and medical use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting TAFINLAR

TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Exclusivity Expiration: ⤷  Sign Up

TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Exclusivity Expiration: ⤷  Sign Up

DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

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 TABLET, FOR SUSPENSION;ORAL 217514-001 Mar 16, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TAFINLAR dabrafenib mesylate TABLET, FOR SUSPENSION;ORAL 217514-001 Mar 16, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  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

International Patents for TAFINLAR

When does loss-of-exclusivity occur for TAFINLAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10306653
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012008854
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 75803
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12000964
Estimated Expiration: ⤷  Sign Up

China

Patent: 2655753
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 31498
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120155
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191617
Estimated Expiration: ⤷  Sign Up

Patent: 0221304
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22013
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000091
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0589
Estimated Expiration: ⤷  Sign Up

Patent: 1290149
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Patent: 59217
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 46139
Estimated Expiration: ⤷  Sign Up

Patent: 60206
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9073
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 18929
Estimated Expiration: ⤷  Sign Up

Patent: 13508294
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4759
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12004413
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 497
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 746
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8913
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 121093
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 181
Estimated Expiration: ⤷  Sign Up

Patent: 702
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 88033
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1202612
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1729116
Estimated Expiration: ⤷  Sign Up

Patent: 120104547
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 45479
Estimated Expiration: ⤷  Sign Up

Patent: 30157
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5064
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAFINLAR around the world.

Country Patent Number Title Estimated Expiration
Cyprus 1113538 ⤷  Sign Up
Montenegro 01480 DERIVATI 5-AMIN0-2,4,7-TRIOKS0-3,4,7,8-TETRAHIDR0-2H-PIRID0[2,3-d]PIRIMIDINA I SRODNI SPOJEVI, NAMIJENJENI LIJEČENJU RAKA (5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO'2,3-D! PYRIMIDINE DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CANCER) ⤷  Sign Up
Portugal 3560498 ⤷  Sign Up
Hong Kong 1206642 輔助癌症治療的方法 (METHOD OF ADJUVANT CANCER TREATMENT) ⤷  Sign Up
Eurasian Patent Organization 019349 СОЕДИНЕНИЯ БЕНЗОЛСУЛЬФОНАМИДТИАЗОЛА И ОКСАЗОЛА (BENZENE SULFONAMIDE THIAZOLE AND OXAZOLE COMPOUNDS) ⤷  Sign Up
Eurasian Patent Organization 020589 ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 CR 2014 00055 Denmark ⤷  Sign Up 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 132014902315090 Italy ⤷  Sign Up 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
1761528 1490063-3 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
1761528 565 Finland ⤷  Sign Up
1761528 300701 Netherlands ⤷  Sign Up 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 C 2014 044 Romania ⤷  Sign Up PRODUCT NAME: TRAMETINIB, OPTIONAL SUB FORMA UNEI SARI, HIDRAT SAU SOLVAT AL ACESTUIA, ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/14/931; DATE OF NATIONAL AUTHORISATION: 20140630; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/931; DATE OF FIRST AUTHORISATION IN EEA: 20140630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.