DABRAFENIB MESYLATE - Generic Drug Details

What are the generic sources for dabrafenib mesylate and what is the scope of freedom to operate?

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

Dabrafenib mesylate has one hundred and seventy-three patent family members in forty-five countries.

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

Summary for DABRAFENIB MESYLATE

International Patents:	173
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	14
Patent Applications:	224
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DABRAFENIB MESYLATE
DailyMed Link:	DABRAFENIB MESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DABRAFENIB MESYLATE

Dosage:

CAPSULE;ORAL

Dosage:

TABLET, FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DABRAFENIB MESYLATE

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

Sponsor	Phase
ECOG-ACRIN Cancer Research Group	Phase 2
Pediatric Brain Tumor Consortium	Phase 1/Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all DABRAFENIB MESYLATE clinical trials

Pharmacology for DABRAFENIB MESYLATE

Drug Class

Kinase Inhibitor

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Protein Kinase Inhibitors

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
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No					Y
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes					Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes					Y

International Patents for DABRAFENIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Morocco	32369	مركبات البنزين السلفوناميد ثيازول و أوكسازول
Poland	1761528
Russian Federation	2015105821	Способ адъювантного лечения рака
Slovenia	1761528
Lithuania	2892535
Croatia	P20221304

Supplementary Protection Certificates for DABRAFENIB MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	CA 2014 00055	Denmark		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
1761528	C01761528/01	Switzerland		PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
1761528	C300701	Netherlands		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
1761528	14C0083	France		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
1761528	CR 2014 00055	Denmark		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 20140702
1761528	C 2014 044	Romania		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