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Generated: February 19, 2018

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 three patent family members in thirty-nine 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 for TAFINLAR

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 TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,642,759 Benzene sulfonamide thiazole and oxazole compounds ➤ Sign Up
7,378,423 Pyrimidine compound and medical use thereof ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for TAFINLAR

Supplementary Protection Certificates for TAFINLAR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014039,C1761528 Lithuania ➤ Sign Up PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
0701 Netherlands ➤ Sign Up 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
2014 00055 Denmark ➤ Sign Up PRODUCT 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
14/063 Ireland ➤ Sign Up 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
00701 Netherlands ➤ Sign Up PRODUCT 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
5 5032-2014 Slovakia ➤ Sign Up PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702
C0083 France ➤ Sign Up PRODUCT 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
0140036 00120 Estonia ➤ Sign Up PRODUCT NAME: TRAMETINIIB;REG NO/DATE: EU/1/14/931 02.07.2014
90063-3 Sweden ➤ Sign Up PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
2014039 Lithuania ➤ Sign Up PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Deloitte
Accenture
QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo
Cantor Fitzgerald
McKinsey
Moodys

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