You’re using a public version of DrugPatentWatch with 1 free search available | Register to unlock more free searches. CREATE FREE ACCOUNT

Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Baxter
Mallinckrodt
Harvard Business School
Merck

Last Updated: February 22, 2024

Trametinib dimethyl sulfoxide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 ⤷  Try a Trial
Novartis MEKINIST trametinib dimethyl sulfoxide SOLUTION;ORAL 217513-001 Mar 16, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114-003 May 29, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Slovenia 2892535 ⤷  Try a Trial
Australia 2010306653 Combination ⤷  Try a Trial
Canada 2727841 DERIVES DE 5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO¬2, 3-D| PYRIMIDINE ET COMPOSES CONNEXES (5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO [2, 3-D] PYRIMIDINE DERIVATIVES AND RELATED COMPOUNDS) ⤷  Try a Trial
Brazil 112015004578 métodos para fornecer tratamento adjuvante a um paciente com uma diagnose anterior de melanoma que foi ressectado e para aumentar sobrevivência sem recaída (rfs) de um paciente depois de ressecção de melanoma, e, composição ⤷  Try a Trial
European Patent Office 2298768 Dérivés 5-amino-2,4,7-trioxo-3,4,7,8-tetrahydro-2H-pyrido[2,3-d]pyrimidine et composés similaires pour le traitement de cancer (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 14C0083 France ⤷  Try a 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 C300701 Netherlands ⤷  Try a 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 565 Finland ⤷  Try a Trial
1761528 132014902315090 Italy ⤷  Try a 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 SPC/GB14/081 United Kingdom ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
Harvard Business School
Baxter
Mallinckrodt
Colorcon

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.