~ Buy the TAFINLAR (dabrafenib mesylate) Drug Profile, 2024 PDF Report in the Report Store ~

TAFINLAR Drug Patent Profile

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

Tafinlar is a drug marketed by Novartis and is included in two NDAs. There are eight patents protecting this drug.

This drug has one hundred and seventy-four patent family members in forty-five 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 April 15, 2031. 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:	174
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	35
Patent Applications:	2,143
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 Loss of Exclusivity (LOE) Date for TAFINLAR

NDA:

202806

Dosage:

CAPSULE;ORAL

NDA:

217514

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 TAFINLAR

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

Sponsor	Phase
Eva Marie Erfurth, MD, PhD	Phase 2
Austin Health	Phase 2
Olivia Newton-John Cancer Research Institute	Phase 2

See all TAFINLAR clinical trials

Pharmacology for TAFINLAR

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 TAFINLAR

TAFINLAR is protected by eight US patents and thirteen FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TAFINLAR

FDA Regulatory Exclusivity protecting 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	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes					Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes

International Patents for TAFINLAR

When does loss-of-exclusivity occur for TAFINLAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAFINLAR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010306653	Combination
Croatia	P20191617
Slovenia	1761528
South Africa	201202612	COMBINATION

Supplementary Protection Certificates for TAFINLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	2014/063	Ireland		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
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	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	PA2014039,C1761528	Lithuania		PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630