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Last Updated: October 24, 2021

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Trametinib dimethyl sulfoxide - Generic Drug Details

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What are the generic sources for trametinib dimethyl sulfoxide and what is the scope of freedom to operate?

Trametinib dimethyl sulfoxide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trametinib dimethyl sulfoxide has one hundred and forty-one patent family members in forty-four countries.

There is one drug master file entry for trametinib dimethyl sulfoxide. One supplier is listed for this compound.

Summary for trametinib dimethyl sulfoxide
Recent Clinical Trials for trametinib dimethyl sulfoxide

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

SponsorPhase
National Cancer Institute (NCI)Phase 1/Phase 2
ECOG-ACRIN Cancer Research GroupPhase 2
National Cancer Institute (NCI)Phase 2

See all trametinib dimethyl sulfoxide clinical trials

Pharmacology for trametinib dimethyl sulfoxide
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for trametinib dimethyl sulfoxide

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 trametinib dimethyl sulfoxide

Country Patent Number Estimated Expiration
Eurasian Patent Organization 025198 ⤷  Free Forever Trial
Japan 4913768 ⤷  Free Forever Trial
Israel 179671 ⤷  Free Forever Trial
European Patent Office 3808343 ⤷  Free Forever Trial
China 107308164 ⤷  Free Forever Trial
Canada 2822701 ⤷  Free Forever Trial
Montenegro 03497 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for trametinib dimethyl sulfoxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 PA2014039,C1761528 Lithuania ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 300701 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528 SPC/GB14/081 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702
1761528 C300701 Netherlands ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FRAMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528 122014000102 Germany ⤷  Free Forever Trial 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 14C0083 France ⤷  Free Forever Trial 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 2014/063 Ireland ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Harvard Business School
Baxter
Mallinckrodt
Colorcon

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