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TAFINLAR Drug Patent 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 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

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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

Drug patent expirations by year for TAFINLAR

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

Generic Entry Dates for TAFINLAR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 202806 Dosage: CAPSULE;ORAL
Generic Entry Dates for TAFINLAR^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Royal Brisbane and Women's Hospital	Phase 2
Eastern Health	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAFINLAR is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Method of adjuvant cancer treatment
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pyrimidine compound and medical use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Benzene sulfonamide thiazole and oxazole compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting TAFINLAR

TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Exclusivity Expiration: ⤷ Sign Up

TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Exclusivity Expiration: ⤷ Sign Up

DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
Exclusivity Expiration: ⤷ Sign Up

DABRAFENIB IS INDICATED IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE NO SATISFACTORY ALTERNATIVE TREATMENT OPTIONS
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

NEW PRODUCT
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Glossary

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

Patent: 10306653
Patent: Combination
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2012008854
Patent: combinação, kit de combinação, uso de uma combinação, composição farmacêutica, e, método para tratar câncer em um ser humano
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 75803
Patent: COMBINAISON (COMBINATION)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 12000964
Patent: Combinacion de n-{3-[3-ciclopropil-5-(2-fluoro-4-yodo-fenilamino)-6,8-dimetil-2,4,7-trioxo-3,4,6,7-tetrahidro-2h-pirido-[4,3d]-pirimidin-1-il]fenil}-acetamida y n-{3-[5-(2-amino-4-pirimidinil)-2-(1,1-dimetil-etil)-1,3-tiazol-4-il]-2-fluoro-fenil}-2,6-difluoro-bencen-sulfonamida; kit; composicion; uso para tratar cancer.
Estimated Expiration: ⤷ Sign Up

China

Patent: 2655753
Patent: Combination
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 31498
Patent: COMBINACIÓN QUE COMPRENDE UN INHIBIDORDE MEK Y UN INHIBIDOR DE B- RAF úTIL EN EL TRATAMIENTO DE TRASTORNOS HIPERPROLIFERATIVOS
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 120155
Patent: COMBINACION
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0191617
Estimated Expiration: ⤷ Sign Up

Patent: 0221304
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 22013
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 88033
Estimated Expiration: ⤷ Sign Up

Patent: 60498
Estimated Expiration: ⤷ Sign Up

Dominican Republic

Patent: 012000091
Patent: COMBINACIONES UTILES PARA EL TRATAMIENTO DE CANCER EN UN MAMIFERO
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 0589
Patent: ПРОТИВОРАКОВАЯ КОМБИНАЦИЯ (ANTICANCER COMBINATION)
Estimated Expiration: ⤷ Sign Up

Patent: 1290149
Patent: КОМБИНАЦИЯ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 88033
Patent: Combination comprenant un inhibiteur de MEK et un inhibiteur de B-raf (Combination comprising an MEK inhibitor and a B-raf inhibitor)
Estimated Expiration: ⤷ Sign Up

Patent: 60498
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Patent: 59217
Patent: COMBINATION COMPRENANT UN INHIBITEUR DE MEK ET UN INHIBITEUR DE B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 46139
Estimated Expiration: ⤷ Sign Up

Patent: 60206
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 9073
Patent: צירוף תרופתי לטיפול בסרטן (Pharmaceutical combination for treatment of cancer)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 18929
Estimated Expiration: ⤷ Sign Up

Patent: 13508294
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 88033
Estimated Expiration: ⤷ Sign Up

Patent: 60498
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 4759
Patent: PHARMACEUTICAL COMBINATION OF MEK INIDBITOR AND B-RAF INHIBITORS
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 12004413
Patent: COMBINACION. (COMBINATION.)
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 497
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 746
Patent: التركيبة
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 8913
Patent: Combination of an MEK inhibitor and a B-Raf inhibitor for the treatment of cancer
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 121093
Patent: COMBINACION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE MEK Y UN INHIBIDOR DE B-RAF
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 88033
Estimated Expiration: ⤷ Sign Up

Patent: 60498
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 88033
Estimated Expiration: ⤷ Sign Up

Patent: 60498
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 181
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Patent: 702
Patent: KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 88033
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1202612
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1729116
Estimated Expiration: ⤷ Sign Up

Patent: 120104547
Patent: COMBINATION
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 45479
Estimated Expiration: ⤷ Sign Up

Patent: 30157
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 5064
Patent: КОМБИНАЦИЯ, СОДЕРЖАЩАЯ ИНГИБИТОР МЭК И ИНГИБИТОР В-Raf;КОМБІНАЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР МЕК ТА ІНГІБІТОР В-Raf (COMBINATION COMPRISING THE MEK INHIBITOR AND B-Raf INHIBITOR)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011047238		⤷ Sign Up
Denmark	1761528		⤷ Sign Up
Portugal	2488033		⤷ Sign Up
Hungary	S1400055		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009137391		⤷ Sign Up
Russian Federation	2020104742	НОВАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ	⤷ Sign Up
Dominican Republic	P2012000091	COMBINACIONES UTILES PARA EL TRATAMIENTO DE CANCER EN UN MAMIFERO	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TAFINLAR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	C01761528/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
1761528	132014902315090	Italy	⤷ Sign Up	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	⤷ Sign Up	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	122014000102	Germany	⤷ Sign Up	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	68/2014	Austria	⤷ Sign Up	PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528	PA2014039,C1761528	Lithuania	⤷ Sign Up	PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
1761528	PA2014039	Lithuania	⤷ Sign Up	PRODUCT NAME: TRAMETINIBUM; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for TAFINLAR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAFINLAR

Recent Clinical Trials for TAFINLAR

Pharmacology for TAFINLAR

Patents protecting TAFINLAR

FDA Regulatory Exclusivity protecting TAFINLAR

When does loss-of-exclusivity occur for TAFINLAR?

Make Better Decisions: Try a trial or see plans & pricing

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