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Last Updated: March 28, 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 twelve patents protecting this drug.

This drug has one hundred and seventy-two 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 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

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
The AlfredPhase 2
Royal Brisbane and Women's HospitalPhase 2

See all TAFINLAR clinical trials

US Patents and Regulatory Information for TAFINLAR

TAFINLAR is protected by twelve US patents and eleven FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pyrimidine compound and medical use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY

Pyrimidine compound and medical use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 2012008854
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 75803
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12000964
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2655753
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 31498
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120155
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0191617
Estimated Expiration: ⤷  Try a Trial

Patent: 0221304
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

Patent: 60498
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 012000091
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 0589
Estimated Expiration: ⤷  Try a Trial

Patent: 1290149
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

Patent: 60498
Estimated Expiration: ⤷  Try a Trial

Patent: 59217
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 46139
Estimated Expiration: ⤷  Try a Trial

Patent: 60206
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9073
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 18929
Estimated Expiration: ⤷  Try a Trial

Patent: 13508294
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

Patent: 60498
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4759
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 12004413
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 497
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 746
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8913
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 121093
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

Patent: 60498
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

Patent: 60498
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 181
Estimated Expiration: ⤷  Try a Trial

Patent: 702
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 88033
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1202612
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1729116
Estimated Expiration: ⤷  Try a Trial

Patent: 120104547
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 45479
Estimated Expiration: ⤷  Try a Trial

Patent: 30157
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5064
Estimated Expiration: ⤷  Try a Trial

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
Russian Federation 2015105821 Способ адъювантного лечения рака ⤷  Try a Trial
Netherlands 300701 ⤷  Try a Trial
Russian Federation 2007101158 ПРОИИЗВОДНЫЕ 5-АМИНО-2,4,7-ТРИЛКСО-3,4,7,8-ТЕТРАГИДРО-2Н-ПИРИДО [2,3-d] ПИРИМИДИНА И РОДСТВЕННЫЕ СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ РАКА ⤷  Try a Trial
Canada 2569850 DERIVES DE 5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO[2,3-D}PYRIMIDINE ET COMPOSES APPARENTES POUR LE TRAITEMENT DU CANCER (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) ⤷  Try a Trial
Hong Kong 1107084 5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2h-pyridoÄ2,3-dÜpyrimidine derivatives and related compoundsfor the treatment of cancer ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 1490063-3 Sweden ⤷  Try a Trial 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 CA 2014 00055 Denmark ⤷  Try a Trial 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
1761528 PA2014039 Lithuania ⤷  Try a Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 C20140036 00120 Estonia ⤷  Try a Trial CHANGE OF OWNER'S ADDRESS
1761528 SPC/GB14/081 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702
>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.