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Serving leading biopharmaceutical companies globally:

Healthtrust
McKinsey
Harvard Business School
Citi
Federal Trade Commission
UBS
Cerilliant
Express Scripts
Fish and Richardson
AstraZeneca

Generated: October 21, 2017

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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 trametinib dimethyl sulfoxide freedom to operate?

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

Trametinib dimethyl sulfoxide has ninety-six patent family members in thirty-nine countries and ten supplementary protection certificates in eight countries.

There is one drug master file entry for trametinib dimethyl sulfoxide. One supplier is listed for this compound.

Summary for Generic Name: trametinib dimethyl sulfoxide

US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list71
Clinical Trials: see list192
Patent Applications: see list165
Drug Prices:see low prices
DailyMed Link:trametinib dimethyl sulfoxide at DailyMed

Pharmacology for Ingredient: trametinib dimethyl sulfoxide

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-001May 29, 2013RXYesNo► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-001May 29, 2013RXYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► Subscribe ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-002May 29, 2013DISCNYesNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
MEKINIST
trametinib dimethyl sulfoxide
TABLET;ORAL204114-003May 29, 2013RXYesYes► Subscribe► 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
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
Australia2011349422► Subscribe
Argentina084102► Subscribe
Dominican RepublicP2012000091► Subscribe
China102655753► Subscribe
Peru10932012► Subscribe
Canada2822701► Subscribe
China101912400► Subscribe
Costa Rica20130352► Subscribe
New Zealand612157► Subscribe
Japan2008201788► 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
2014 00055Denmark► SubscribePRODUCT 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
2014039Lithuania► SubscribePRODUCT NAME: TRAMETINIBUM; 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
5 5032-2014Slovakia► SubscribePRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 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
0701Netherlands► SubscribePRODUCT 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
2014039,C1761528Lithuania► SubscribePRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
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
0140036 00120Estonia► SubscribePRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
C0083France► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Teva
AstraZeneca
Cipla
Queensland Health
Moodys
McKinsey
Dow
Accenture
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 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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