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 two branded drugs marketed by Novartis and Novugen, and is included in three NDAs. There are nine 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:	9
Tradenames:	2
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	15
Patent Applications:	264
DailyMed Link:	trametinib dimethyl sulfoxide at DailyMed

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	⤷ Subscribe	⤷ Subscribe			Y	⤷ Subscribe
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-001	May 29, 2013		RX	Yes	No	⤷ Subscribe	⤷ Subscribe			Y	⤷ Subscribe
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-003	May 29, 2013		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe			Y	⤷ Subscribe
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis	MEKINIST	trametinib dimethyl sulfoxide	TABLET;ORAL	204114-002	May 29, 2013		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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
South Korea	20130130028	NOVEL PHARMACEUTICAL COMPOSITION	⤷ Subscribe
Eurasian Patent Organization	020589	ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION)	⤷ Subscribe
Serbia	59181	KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)	⤷ Subscribe
China	107308164	辅助癌症治疗的方法 (Method of adjuvant cancer treatment)	⤷ Subscribe
Cyprus	1124812		⤷ Subscribe
China	104582706	Method of adjuvant cancer treatment	⤷ Subscribe
>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	PA2014039,C1761528	Lithuania	⤷ Subscribe	PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	300701	Netherlands	⤷ Subscribe	PRODUCT NAME: TRAMETINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140702
1761528	205 5032-2014	Slovakia	⤷ Subscribe	PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
1761528	1490063-3	Sweden	⤷ Subscribe	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	2014/063	Ireland	⤷ Subscribe	PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/14/931/001-006 20140702
1761528	C20140036 00120	Estonia	⤷ Subscribe	CHANGE OF OWNER'S ADDRESS
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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