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Last Updated: May 23, 2024

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MEKINIST Drug Patent Profile


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When do Mekinist patents expire, and when can generic versions of Mekinist launch?

Mekinist is a drug marketed by Novartis and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-nine patent family members in forty-six countries.

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.

DrugPatentWatch® Generic Entry Outlook for Mekinist

Mekinist 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for MEKINIST
International Patents:169
US Patents:12
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 92
Patent Applications: 3,196
Drug Prices: Drug price information for MEKINIST
What excipients (inactive ingredients) are in MEKINIST?MEKINIST excipients list
DailyMed Link:MEKINIST at DailyMed
Drug patent expirations by year for MEKINIST
Drug Prices for MEKINIST

See drug prices for MEKINIST

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MEKINIST
Generic Entry Dates for MEKINIST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for MEKINIST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;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 MEKINIST

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

SponsorPhase
Erasca, Inc.Phase 1
Peter Hosein, MDPhase 1
University of Miami Sylvester Comprehensive Cancer CenterPhase 1

See all MEKINIST clinical trials

Pharmacology for MEKINIST
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for MEKINIST
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MEKINIST Tablets trametinib dimethyl sulfoxide 0.5 mg and 2 mg 204114 1 2023-09-28

US Patents and Regulatory Information for MEKINIST

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MEKINIST 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 MEKINIST

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

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

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

Pharmaceutical composition
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
Patented Use: MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pyrimidine compound and medical use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, 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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting MEKINIST

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

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

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

TRAMETINIB IN COMBINATION WITH DABRAFENIB, 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 WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

TRAMETINIB IS INDICATED IN COMBINATION WITH DABRAFENIB, 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 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 MEKINIST

When does loss-of-exclusivity occur for MEKINIST?

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

Argentina

Patent: 4102
Estimated Expiration: ⤷  Sign Up

Patent: 2185
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10306653
Estimated Expiration: ⤷  Sign Up

Patent: 11349422
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012008854
Estimated Expiration: ⤷  Sign Up

Patent: 2013015602
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 75803
Estimated Expiration: ⤷  Sign Up

Patent: 22701
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12000964
Estimated Expiration: ⤷  Sign Up

Patent: 13001779
Estimated Expiration: ⤷  Sign Up

China

Patent: 2655753
Estimated Expiration: ⤷  Sign Up

Patent: 3998041
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 31498
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 120155
Estimated Expiration: ⤷  Sign Up

Patent: 130352
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0191617
Estimated Expiration: ⤷  Sign Up

Patent: 0201409
Estimated Expiration: ⤷  Sign Up

Patent: 0221304
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 22013
Estimated Expiration: ⤷  Sign Up

Patent: 23376
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 012000091
Estimated Expiration: ⤷  Sign Up

Patent: 013000138
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0589
Estimated Expiration: ⤷  Sign Up

Patent: 5198
Estimated Expiration: ⤷  Sign Up

Patent: 1290149
Estimated Expiration: ⤷  Sign Up

Patent: 1390913
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Patent: 08343
Estimated Expiration: ⤷  Sign Up

Patent: 59204
Estimated Expiration: ⤷  Sign Up

Patent: 59205
Estimated Expiration: ⤷  Sign Up

Patent: 59217
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 46139
Estimated Expiration: ⤷  Sign Up

Patent: 50788
Estimated Expiration: ⤷  Sign Up

Patent: 60206
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9073
Estimated Expiration: ⤷  Sign Up

Patent: 6855
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 18929
Estimated Expiration: ⤷  Sign Up

Patent: 26014
Estimated Expiration: ⤷  Sign Up

Patent: 13508294
Estimated Expiration: ⤷  Sign Up

Patent: 14510704
Estimated Expiration: ⤷  Sign Up

Patent: 17137299
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 94
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 0501
Estimated Expiration: ⤷  Sign Up

Patent: 4759
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12004413
Estimated Expiration: ⤷  Sign Up

Patent: 13007073
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 497
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 746
Estimated Expiration: ⤷  Sign Up

Patent: 883
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8913
Estimated Expiration: ⤷  Sign Up

Patent: 2157
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 121093
Estimated Expiration: ⤷  Sign Up

Patent: 140040
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

Patent: 60498
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 181
Estimated Expiration: ⤷  Sign Up

Patent: 702
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 1054
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 88033
Estimated Expiration: ⤷  Sign Up

Patent: 54736
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1202612
Estimated Expiration: ⤷  Sign Up

Patent: 1304189
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1729116
Estimated Expiration: ⤷  Sign Up

Patent: 1911109
Estimated Expiration: ⤷  Sign Up

Patent: 120104547
Estimated Expiration: ⤷  Sign Up

Patent: 130130028
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 45479
Estimated Expiration: ⤷  Sign Up

Patent: 20536
Estimated Expiration: ⤷  Sign Up

Patent: 30157
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 05828
Estimated Expiration: ⤷  Sign Up

Patent: 1249441
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5064
Estimated Expiration: ⤷  Sign Up

Patent: 3158
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 818
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 MEKINIST around the world.

Country Patent Number Title Estimated Expiration
Australia 2016244279 METHOD OF ADJUVANT CANCER TREATMENT ⤷  Sign Up
Montenegro 03497 KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR) ⤷  Sign Up
Dominican Republic P2013000138 NUEVA COMPOSICIÓN FARMACÉUTICA ⤷  Sign Up
Japan 2018058859 アジュバント癌治療の方法 (METHOD OF ADJUVANT CANCER TREATMENT) ⤷  Sign Up
Peru 20121093 COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF ⤷  Sign Up
Hong Kong 1206642 輔助癌症治療的方法 (METHOD OF ADJUVANT CANCER TREATMENT) ⤷  Sign Up
Spain 2820536 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MEKINIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 PA2014039,C1761528 Lithuania ⤷  Sign Up PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
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 122014000102 Germany ⤷  Sign Up PRODUCT NAME: TRAMETINIB, GEGEBENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 C01761528/01 Switzerland ⤷  Sign Up PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
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
1761528 205 5032-2014 Slovakia ⤷  Sign Up PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
1761528 68/2014 Austria ⤷  Sign Up PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 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.