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Last Updated: May 19, 2022

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 one NDA. There are seven patents protecting this drug.

This drug has one hundred and fifty-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 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
Austin HealthPhase 2
Olivia Newton-John Cancer Research InstitutePhase 2
Royal North Shore HospitalPhase 2

See all TAFINLAR clinical trials

US Patents and Regulatory Information for TAFINLAR

TAFINLAR is protected by twenty-two US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MELANOMA

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR(R) IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, 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

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TAFINLAR IS INDICATED AS A SINGLE AGENT FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION

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: See Plans and Pricing

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: See Plans and Pricing

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: See Plans and Pricing

ADDITION OF STUDY BRF117277, A NON-RANDOMIZED, OPEN-LABEL, MULTI-CENTER, MULTI-COHORT TRIAL OF DABRAFENIB PLUS TRAMETINIB IN SUBJECTS WITH BRAF MUTATION-POSITIVE MELANOMA THAT HAS METASTASIZED TO THE BRAIN
Exclusivity Expiration: See Plans and Pricing

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 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2012008854
Estimated Expiration: See Plans and Pricing

Canada

Patent: 75803
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12000964
Estimated Expiration: See Plans and Pricing

China

Patent: 2655753
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 31498
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 120155
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0191617
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 88033
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 012000091
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0589
Estimated Expiration: See Plans and Pricing

Patent: 1290149
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 88033
Estimated Expiration: See Plans and Pricing

Patent: 60498
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 46139
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9073
Estimated Expiration: See Plans and Pricing

Japan

Patent: 18929
Estimated Expiration: See Plans and Pricing

Patent: 13508294
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 88033
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4759
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12004413
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 497
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 746
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8913
Estimated Expiration: See Plans and Pricing

Peru

Patent: 121093
Estimated Expiration: See Plans and Pricing

Poland

Patent: 88033
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 88033
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 181
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 88033
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1202612
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1729116
Estimated Expiration: See Plans and Pricing

Patent: 120104547
Estimated Expiration: See Plans and Pricing

Spain

Patent: 45479
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5064
Estimated Expiration: See Plans and Pricing

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
Portugal 2298768 See Plans and Pricing
Serbia 52670 DERIVATI 5-AMINO-2,4,7-TRIOKSO-3,4,7,8-TETRAHIDRO-2H-PIRIDO(2,3-D)PIRIMIDINA I SLIČNA JEDINJENJA ZA LEČENJE KANCERA (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) See Plans and Pricing
Hungary E056646 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAFINLAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 C 2014 044 Romania See Plans and Pricing 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
1761528 C01761528/01 Switzerland See Plans and Pricing PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
1761528 CA 2014 00055 Denmark See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Johnson and Johnson
Moodys
Baxter
McKinsey
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Mallinckrodt

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.