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TAFINLAR Drug Profile

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Which patents cover Tafinlar, and what generic alternatives are available?

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

This drug has one hundred and twenty-one patent family members in forty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Tafinlar

Tafinlar was eligible for patent challenges on May 29, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for TAFINLAR

International Patents:	121
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	28
Patent Applications:	2,220
Drug Prices:	Drug price information for TAFINLAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAFINLAR
What excipients (inactive ingredients) are in TAFINLAR?	TAFINLAR excipients list
DailyMed Link:	TAFINLAR at DailyMed

See drug prices for TAFINLAR

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for TAFINLAR

NDA:

202806

Dosage:

CAPSULE;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 TAFINLAR

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

Sponsor	Phase
University of Zurich	Phase 2
ECOG-ACRIN Cancer Research Group	Phase 2
JS InnoPharm, LLC	Phase 1

See all TAFINLAR clinical trials

Pharmacology for TAFINLAR

Drug Class

Kinase Inhibitor

Mechanism of Action

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

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	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	202806-002	May 29, 2013		RX	Yes	Yes
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes

International Patents for TAFINLAR

Country	Patent Number	Estimated Expiration
Morocco	32369
South Korea	101729116
Ukraine	105064
European Patent Office	3560498

Supplementary Protection Certificates for TAFINLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	1490063-3	Sweden		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REG. NO/DATE: EU/1/14/931 20140702
1761528	132014902315090	Italy		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	300701	Netherlands		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
1761528	205 5032-2014	Slovakia		PRODUCT NAME: TRAMETINIB, PRIPADNE VO FORME JEHO FARMACEUTICKY PRIJATELNEJ SOLI, HYDRATU ALEBO SOLVATU; REGISTRATION NO/DATE: EU/1/14/931 20140702