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Last Updated: June 16, 2021

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MEKINIST Drug 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 eight patents protecting this drug.

This drug has one hundred and seventeen patent family members in forty-two 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:117
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 91
Clinical Trials: 70
Patent Applications: 2,614
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
Saint Petersburg State University, RussiaPhase 2
University of ZurichPhase 2
The Lilabean Foundation for Pediatric Brain Cancer ResearchPhase 1

See all MEKINIST clinical trials

Pharmacology for MEKINIST
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for MEKINIST

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

Supplementary Protection Certificates for MEKINIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 14C0083 France   Get Started Free PRODUCT NAME: TRAMETINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL,HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/931 20140630
1761528 PA2014039,C1761528 Lithuania   Get Started Free PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 CA 2014 00055 Denmark   Get Started Free 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Moodys
Express Scripts
Mallinckrodt
AstraZeneca

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