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Last Updated: June 29, 2022

MEKINIST Drug Patent Profile


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When do Mekinist patents expire, and what generic alternatives are available?

Mekinist is a drug marketed by Novartis and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and fifty-two patent family members in forty-five 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 January 28, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for MEKINIST
International Patents:152
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 88
Patent Applications: 180
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 Generic Entry Opportunity Date for MEKINIST
Generic Entry Date for MEKINIST*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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
University Hospital, Strasbourg, FrancePhase 2
Monash HealthPhase 2
The AlfredPhase 2

See all MEKINIST clinical trials

Pharmacology for MEKINIST
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors

US Patents and Regulatory Information for MEKINIST

MEKINIST is protected by eighteen US patents and four FDA Regulatory Exclusivities.

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

Method of adjuvant cancer treatment
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MEKINIST(R) 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

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MEKINIST IN COMBINATION WITH DABRAFENIB 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: MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION 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: MEKINIST 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

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MEKINIST IS INDICATED, AS A SINGLE AGENT OR IN COMBINATION WITH DABRAFENIB, 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: MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, 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: MEKINIST 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

Pyrimidine compound and medical use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA

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

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting MEKINIST

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

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: 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 MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y 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 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: See Plans and Pricing

Australia

Patent: 11349422
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013015602
Estimated Expiration: See Plans and Pricing

Canada

Patent: 22701
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13001779
Estimated Expiration: See Plans and Pricing

China

Patent: 3998041
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 130352
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0201409
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 54736
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 013000138
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5198
Estimated Expiration: See Plans and Pricing

Patent: 1390913
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54736
Estimated Expiration: See Plans and Pricing

Patent: 08343
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 50788
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6855
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26014
Estimated Expiration: See Plans and Pricing

Patent: 14510704
Estimated Expiration: See Plans and Pricing

Patent: 17137299
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 94
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 54736
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0501
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 13007073
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 883
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2157
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140040
Estimated Expiration: See Plans and Pricing

Poland

Patent: 54736
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 54736
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 1054
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 54736
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1304189
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1911109
Estimated Expiration: See Plans and Pricing

Patent: 130130028
Estimated Expiration: See Plans and Pricing

Spain

Patent: 20536
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 05828
Estimated Expiration: See Plans and Pricing

Patent: 1249441
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3158
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 818
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 MEKINIST around the world.

Country Patent Number Title Estimated Expiration
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) See Plans and Pricing
New Zealand 598913 Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer See Plans and Pricing
Dominican Republic P2013000138 NUEVA COMPOSICIÓN FARMACÉUTICA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MEKINIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 68/2014 Austria See Plans and Pricing PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528 122014000102 Germany See Plans and Pricing 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 PA2014039 Lithuania See Plans and Pricing PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
Express Scripts
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AstraZeneca

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.