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Last Updated: September 18, 2020

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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 eleven 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
International Patents:111
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 38
Clinical Trials: 9
Patent Applications: 56
DailyMed Link:trametinib dimethyl sulfoxide at DailyMed
Recent Clinical Trials for trametinib dimethyl sulfoxide

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
National Human Genome Research Institute (NHGRI)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 204114-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-001 May 29, 2013 RX 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 204114-001 May 29, 2013 RX Yes No   Start Trial   Start Trial Y   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 trametinib dimethyl sulfoxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 122014000102 Germany   Start 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 SPC/GB14/081 United Kingdom   Start 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 PA2014039 Lithuania   Start Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 132014902315090 Italy   Start Trial PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702
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:

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Merck

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