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Trametinib dimethyl sulfoxide - Generic Drug Details

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Trametinib dimethyl sulfoxide is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-eight patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for Generic Name: trametinib dimethyl sulfoxide

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list2
Drug Prices:see low prices

Pharmacology for Ingredient: trametinib dimethyl sulfoxide

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYes► subscribe► subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYes► subscribe► subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-001May 29, 2013RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: trametinib dimethyl sulfoxide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,952,018Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors► subscribe
9,399,021Pharmaceutical composition► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: trametinib dimethyl sulfoxide

Country Document Number Estimated Expiration
South Africa201202612► subscribe
Japan2014510704► subscribe
Mexico2013007073► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TRAMETINIB DIMETHYL SULFOXIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014039,C1761528Lithuania► subscribePRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
90063-3Sweden► subscribePRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
2014039Lithuania► subscribePRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
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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 verifification 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.

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