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Last Updated: March 28, 2024

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 two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for trametinib dimethyl sulfoxide
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for trametinib dimethyl sulfoxide
Generic Entry Dates for trametinib dimethyl sulfoxide*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for trametinib dimethyl sulfoxide*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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 trametinib dimethyl sulfoxide

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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
National Cancer Institute (NCI)Phase 3

See all trametinib dimethyl sulfoxide clinical trials

Pharmacology for trametinib dimethyl sulfoxide
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for TRAMETINIB DIMETHYL SULFOXIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MEKINIST Tablets trametinib dimethyl sulfoxide 0.5 mg and 2 mg 204114 1 2023-09-28

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-002 May 29, 2013 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 Title Estimated Expiration
Argentina 084102 COMPRIMIDO FARMACEUTICO QUE COMPRENDE EL SOLVATO DE DIMETILSULFOXIDO DE LA N-{3-[3-CICLOPROPIL-5-(2-FLUORO-4-YODO-FENILAMINO)-6,8-DIMETIL-2,4,7-TRIOXO-3,4,6,7-TETRAHIDRO-2H-PIRIDO[4,3-D]PIRIMIDIN-1-IL]FENIL}ACETAMIDA, SU USO PARA PREPARAR UN MEDICAMENTO UTIL PARA TRATAR EL CANCER EN UN SER HUMANO Y PROCEDIMIENTO PARA PREPARAR DICHOS COMPRIMIDOS ⤷  Try a Trial
Russian Federation 2015105821 Способ адъювантного лечения рака ⤷  Try a Trial
New Zealand 552090 5-Amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine derivatives and related compounds for the treatment of cancer ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for trametinib dimethyl sulfoxide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 1490063-3 Sweden ⤷  Try a Trial PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
1761528 CA 2014 00055 Denmark ⤷  Try a 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 20140630
1761528 PA2014039 Lithuania ⤷  Try a Trial PRODUCT NAME: TRAMETINIBUM; 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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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.