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Last Updated: September 18, 2020

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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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dabrafenib mesylate has one hundred and twenty-one patent family members in forty-three 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
National Cancer Institute (NCI)Phase 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 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-002 May 29, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806-001 May 29, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for dabrafenib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1761528 122014000102 Germany   Start Trial PRODUCT NAME: TRAMETINIB, GEGEBENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 SPC/GB14/081 United Kingdom   Start Trial 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 PA2014039 Lithuania   Start Trial PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528 132014902315090 Italy   Start Trial 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
1761528 C01761528/01 Switzerland   Start Trial PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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