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MEKINIST Drug Profile

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Which patents cover Mekinist, and what substitute generic drugs are available?

Mekinist is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this drug.

This drug has eighty-four patent family members in thirty-eight countries.

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.

Summary for Tradename: MEKINIST

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list57
Clinical Trials: see list41
Patent Applications: see list83
Drug Prices:see details
DailyMed Link:MEKINIST at DailyMed

Pharmacology for Tradename: MEKINIST

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes8,580,304► SubscribeY ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-001May 29, 2013RXYesNo8,835,443► Subscribe ► Subscribe
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Non-Orange Book Patents for Tradename: MEKINIST

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
9,399,021Pharmaceutical composition► Subscribe
8,952,018Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors► 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 Tradename: MEKINIST

Country Document Number Estimated Expiration
Uruguay33818► Subscribe
World Intellectual Property Organization (WIPO)2011047238► Subscribe
Spain2397825► Subscribe
Eurasian Patent Organization025198► Subscribe
Germany602005004286► 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: MEKINIST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014039Lithuania► SubscribePRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
0140036 00120Estonia► SubscribePRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
5 5032-2014Slovakia► SubscribePRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
14/063Ireland► SubscribePRODUCT 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
00701Netherlands► SubscribePRODUCT 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
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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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