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Last Updated: July 12, 2020

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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 eleven 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.

US ANDA Litigation and 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
Drug patent expirations by year for MEKINIST
Drug Prices for MEKINIST

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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
M.D. Anderson Cancer CenterPhase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
Novartis PharmaceuticalsPhase 4

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   Start Trial   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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 PA2014039 Lithuania   Start Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 C20140036 00120 Estonia   Start Trial PRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
1761528 565 Finland   Start Trial
1761528 C01761528/01 Switzerland   Start Trial PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Moodys
Express Scripts
Mallinckrodt
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.