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Last Updated: August 2, 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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Trametinib dimethyl sulfoxide has one hundred and seventeen patent family members in forty-two 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 204114-002 May 29, 2013 DISCN 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 Y ⤷  Free Forever Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN 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

Supplementary Protection Certificates for TRAMETINIB DIMETHYL SULFOXIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 PA2014039 Lithuania ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 CR 2014 00055 Denmark ⤷  Free Forever Trial 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 20140702
1761528 565 Finland ⤷  Free Forever Trial
1761528 PA2014039,C1761528 Lithuania ⤷  Free Forever Trial PRODUCT NAME: TRAMETINIBAS; 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:

Express Scripts
Boehringer Ingelheim
Medtronic
Mallinckrodt
Moodys
Johnson and Johnson

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