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Last Updated: October 6, 2022

Dabrafenib mesylate - Generic Drug Details


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What are the generic sources for dabrafenib mesylate and what is the scope of patent protection?

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

Dabrafenib mesylate has one hundred and fifty-two patent family members in forty-five countries.

There is one drug master file entry for dabrafenib mesylate. One supplier is listed for this compound.

Recent Clinical Trials for dabrafenib mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
Pediatric Brain Tumor ConsortiumPhase 1/Phase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all dabrafenib mesylate clinical trials

US Patents and Regulatory Information for dabrafenib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for dabrafenib mesylate

Country Patent Number Title Estimated Expiration
Hungary E028820 See Plans and Pricing
Denmark 2298768 See Plans and Pricing
Brazil PI0912541 composto, composição farmacêutica, processo para preparar um composto, e, uso de um composto See Plans and Pricing
India 449KON2015 See Plans and Pricing
Poland 2298768 See Plans and Pricing
Hungary E056646 See Plans and Pricing
Japan 2015527374 アジュバント癌治療の方法 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dabrafenib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 SPC/GB14/081 United Kingdom See Plans and Pricing PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702
1761528 C 2014 044 Romania See Plans and Pricing PRODUCT NAME: TRAMETINIB, OPTIONAL SUB FORMA UNEI SARI, HIDRAT SAU SOLVAT AL ACESTUIA, ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/14/931; DATE OF NATIONAL AUTHORISATION: 20140630; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/931; DATE OF FIRST AUTHORISATION IN EEA: 20140630
1761528 PA2014039,C1761528 Lithuania See Plans and Pricing PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 68/2014 Austria See Plans and Pricing PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528 C20140036 00120 Estonia See Plans and Pricing CHANGE OF OWNER'S ADDRESS
1761528 PA2014039 Lithuania See Plans and Pricing PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 132014902315090 Italy See Plans and Pricing PRODUCT NAME: TRAMETINIB, OPZIONALMENTE NELLA FORMA DI UN SUO SALE, IDRATO O SOLVATO FARMACEUTICAMENTE ACCETTABILE(MEKINIST); AUTHORISATION NUMBER(S) AND DATE(S): EU/I/14/931/001-006, 20140702
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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