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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Accenture
Moodys
McKinsey
Argus Health
Cerilliant
Citi
Covington
Julphar

Generated: December 12, 2017

DrugPatentWatch Database Preview

TAFINLAR Drug Profile

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When do Tafinlar patents expire, and what generic alternatives are available?

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

This drug has one hundred and four patent family members in thirty-nine countries and ten supplementary protection certificates in eight countries.

The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dabrafenib mesylate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-002May 29, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Novartis Pharms CorpTAFINLARdabrafenib mesylateCAPSULE;ORAL202806-001May 29, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: TAFINLAR

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
8,642,759Benzene sulfonamide thiazole and oxazole compounds► Subscribe
7,378,423Pyrimidine compound and medical use thereof► 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: TAFINLAR

Country Document Number Estimated Expiration
Israel179671► Subscribe
Israel219073► Subscribe
Luxembourg92602► Subscribe
CroatiaP20121020► Subscribe
China102083312► Subscribe
World Intellectual Property Organization (WIPO)2011047238► Subscribe
Germany602005004286► Subscribe
Japan4163738► Subscribe
SloveniaEP2282636► Subscribe
Australia2009244491► 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: TAFINLAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
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
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
2014039,C1761528Lithuania► SubscribePRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
5 5032-2014Slovakia► SubscribePRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
0140036 00120Estonia► SubscribePRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
AstraZeneca
Cantor Fitzgerald
Cipla
Baxter
Boehringer Ingelheim
Chubb
Cerilliant
Covington

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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