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:	2,165
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

Constraining patent/regulatory exclusivity:

8,703,781*PED

NDA:

202806

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,703,781*PED

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
Monash Health	Phase 2
The Alfred	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 eleven FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,703,781.

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

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	7,994,185*PED				Y
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
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		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
European Patent Office	3981408
European Patent Office	1761528	DERIVES DE 5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO[2,3-D]PYRIMIDINE ET COMPOSES APPARENTES POUR LE TRAITEMENT DU CANCER (5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO[2,3-D]PYRIMIDINE DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CANCER)
India	449KON2015
Mexico	PA06014478	DERIVADOS DE 5-AMINO-2, 4, 7-TRIOXO-3, 4, 7, 8-TETRAHIDRO -2H-PIRIDO[2, 3-D]PIRIMIDINA Y COMPUESTOS RELACIONADOS PARA EL TRATAMIENTO DEL CANCER. (5-AMINO-2,4,7-TRIOXO-3,4,7,8-TETRAHYDRO-2H-PYRIDO'2,3-D! PYRIMIDINE DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CANCER.)
Serbia	59181	KOMBINACIJA KOJA SADRŽI INHIBITOR MEK I INHIBITOR B-RAF (COMBINATION COMPRISING AN MEK INHIBITOR AND A B-RAF INHIBITOR)
World Intellectual Property Organization (WIPO)	2014039375

Supplementary Protection Certificates for TAFINLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	122014000102	Germany		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	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	565	Finland
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	PA2014039,C1761528	Lithuania		PRODUCT NAME: TRAMETINIBAS; REGISTRATION NO/DATE: EU/1/14/931/01-06 20140630

Market Dynamics and Financial Trajectory for Tafinlar

Introduction

Tafinlar, also known as dabrafenib, is a mutant-BRAF kinase inhibitor developed for the treatment of unresectable or metastatic melanoma in patients with the BRAF V600 mutation. Here, we delve into the market dynamics and financial trajectory of Tafinlar, highlighting its approval, clinical benefits, market performance, and financial impact.

Approval and Clinical Benefits

Tafinlar was approved by regulatory bodies such as Health Canada and the US FDA for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. The approval was based on clinical trials that demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) when used as a monotherapy or in combination with trametinib (Mekinist)[1][5].

Monotherapy Efficacy

In the pivotal Phase III study, Tafinlar showed a 70% reduction in the risk of disease progression or death compared to dacarbazine (DTIC). This benefit was consistent across various subgroups of patients[1].

Combination Therapy

When used in combination with Mekinist, Tafinlar achieved a statistically significant overall survival benefit compared to monotherapy. The COMBI-d and COMBI-v studies demonstrated improved OS rates, with a median OS of 25.1 months for the combination therapy versus 18.7 months for Tafinlar monotherapy[5].

Market Dynamics

Competitive Landscape

Tafinlar is the second BRAF inhibitor approved for patients with BRAF V600 mutation-positive melanoma, following the approval of Zelboraf (vemurafenib) in 2012. The combination of Tafinlar and Mekinist has positioned Novartis as a key player in the targeted therapy market for melanoma[1].

Growth Drivers

Tafinlar, along with Mekinist, is one of the key growth drivers for Novartis. The combination therapy has been instrumental in driving revenue growth, particularly in the oncology segment. Other growth drivers for Novartis include Cosentyx, Entresto, and Promacta/Revolade[2].

Financial Trajectory

Revenue Impact

The approval and subsequent market performance of Tafinlar have significantly contributed to Novartis's revenue. In the nine months of 2017, volume growth from Tafinlar and Mekinist, among other products, helped offset the negative impacts of generic competition and pricing pressures. The combination therapy has been a crucial component of Novartis's financial performance, contributing to net sales growth[2].

Financial Performance Metrics

• Net Sales: The combination of Tafinlar and Mekinist has contributed to Novartis's net sales growth. For instance, in the first nine months of 2017, net sales were $36.2 billion, with volume growth from these products being a key factor[2].
• Operating Income: The strong performance of Tafinlar and Mekinist has also driven operating income. In Q3 2017, operating income was $2.4 billion, with growth drivers and productivity offsetting generic erosion[2].
• Net Income and EPS: The financial success of Tafinlar and Mekinist has reflected in Novartis's net income and earnings per share (EPS). In Q3 2017, net income was $2.1 billion, and EPS was $0.89, driven by the strong operating income and the benefit from the share buyback program[2].

Adverse Reactions and Safety Profile

While Tafinlar has shown significant clinical benefits, it is associated with several adverse reactions. The most common adverse drug reactions include hyperkeratosis, headache, pyrexia, palmar-plantar erythrodysaesthesia, asthenia, arthralgia, fatigue, nausea, skin papilloma, alopecia, rash, and vomiting. These side effects have been integrated into the product monograph and consumer information sections[1].

Regulatory Milestones

Tafinlar and the combination therapy with Mekinist have achieved several regulatory milestones. The European Medicines Agency (EMA) and the US FDA have granted positive opinions and priority reviews, respectively, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation[5].

Ongoing Clinical Trials and Future Prospects

The combination of Tafinlar and Mekinist is being investigated in ongoing clinical trials across a range of tumor types. These trials aim to expand the therapeutic indications of this combination, potentially opening up new market opportunities and further solidifying Novartis's position in the oncology market[5].

Key Takeaways

• Clinical Efficacy: Tafinlar, both as a monotherapy and in combination with Mekinist, has demonstrated significant clinical benefits in treating patients with BRAF V600 mutation-positive melanoma.
• Market Performance: The drug has been a key growth driver for Novartis, contributing to revenue and operating income growth.
• Financial Impact: Tafinlar's success has positively impacted Novartis's financial metrics, including net sales, operating income, and EPS.
• Regulatory Milestones: The combination therapy has achieved important regulatory approvals and designations.
• Future Prospects: Ongoing clinical trials aim to expand the therapeutic indications of Tafinlar and Mekinist.

FAQs

What is Tafinlar used for?

Tafinlar (dabrafenib) is used for the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600 mutation.

How does Tafinlar work?

Tafinlar works by inhibiting the BRAF kinase, which is involved in the RAS/RAF/MEK/ERK pathway implicated in melanoma and other cancers.

What are the common adverse reactions associated with Tafinlar?

Common adverse reactions include hyperkeratosis, headache, pyrexia, palmar-plantar erythrodysaesthesia, asthenia, arthralgia, fatigue, nausea, skin papilloma, alopecia, rash, and vomiting.

What is the benefit of combining Tafinlar with Mekinist?

The combination of Tafinlar and Mekinist has shown a statistically significant overall survival benefit compared to Tafinlar monotherapy, with improved PFS and OS rates.

How has Tafinlar impacted Novartis's financial performance?

Tafinlar, particularly in combination with Mekinist, has been a key growth driver for Novartis, contributing to revenue growth, operating income, and EPS.

Sources

1. Health Canada: Summary Basis of Decision for Tafinlar.
2. BioSpace: Novartis Could Still Spin Off Alcon, But Not Before 2019.
3. Business Wire: Ligand Reports First Quarter 2023 Financial Results.
4. PubMed: Dabrafenib: first global approval.
5. Novartis: Novartis combination therapy Tafinlar® and Mekinist® achieves important EU and US regulatory milestones.