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-nine patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for trametinib dimethyl sulfoxide

International Patents:	169
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	15
Patent Applications:	311
DailyMed Link:	trametinib dimethyl sulfoxide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for trametinib dimethyl sulfoxide

Generic Entry Dates for trametinib dimethyl sulfoxide^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for trametinib dimethyl sulfoxide^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 2
Pediatric Brain Tumor Consortium	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 3

See all trametinib dimethyl sulfoxide clinical trials

Pharmacology for trametinib dimethyl sulfoxide

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for trametinib dimethyl sulfoxide

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
Mexico	2012004413	COMBINACION. (COMBINATION.)	⤷ Sign Up
South Africa	201304189	NOVEL PHARMACEUTICAL COMPOSITION	⤷ Sign Up
European Patent Office	4159217	COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)	⤷ Sign Up
Montenegro	03497	KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)	⤷ Sign Up
Morocco	33746	التركيبة	⤷ Sign Up
Peru	20140040	COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE LA ACTIVIDAD DE MEK	⤷ Sign Up
South Africa	201202612	COMBINATION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for trametinib dimethyl sulfoxide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	C01761528/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
1761528	565	Finland	⤷ Sign Up
1761528	14C0083	France	⤷ Sign Up	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	122014000102	Germany	⤷ Sign Up	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	1490063-3	Sweden	⤷ Sign Up	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	C300701	Netherlands	⤷ Sign Up	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	CA 2014 00055	Denmark	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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