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-four 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:	174
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

Constraining patent/regulatory exclusivity:

8,703,781*PED

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

8,703,781*PED

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

Anatomical Therapeutic Chemical (ATC) Classes for DABRAFENIB MESYLATE

L01EC	B-Raf serine-threonine kinase (BRAF) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	202806-001	May 29, 2013		RX	Yes	No
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No	8,835,443*PED				Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes	8,415,345*PED				Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No
Novartis	TAFINLAR	dabrafenib mesylate	TABLET, FOR SUSPENSION;ORAL	217514-001	Mar 16, 2023		RX	Yes	Yes	8,415,345*PED				Y

International Patents for DABRAFENIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Hungary	E060206
Spain	2900825
Poland	1761528
Ukraine	103319	СПОЛУКИ БЕНЗЕНСУЛЬФОНАМІДТІАЗОЛУ ТА -ОКСАЗОЛУ[СОЕДИНЕНИЯ БЕНЗЕНСУЛЬФОНАМИДТИАЗОЛА И -ОКСАЗОЛА (THIAZOLE- AND OXAZOLE-BENZENE SULFONAMIDE COMPOUNDS)
Hong Kong	1147907	苯磺酰胺噻唑及噁唑化合物 (BENZENE SULFONAMIDE THIAZOLE AND OXAZOLE COMPOUNDS)
Eurasian Patent Organization	201001680	СОЕДИНЕНИЯ БЕНЗОЛСУЛЬФОНАМИДТИАЗОЛА И ОКСАЗОЛА

Supplementary Protection Certificates for DABRAFENIB MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1761528	565	Finland
1761528	C01761528/01	Switzerland		PRODUCT NAME: TRAMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65883 22.02.2016
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	68/2014	Austria		PRODUCT NAME: TRAMETINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/14/931 (MITTEILUNG) 20140702
1761528	SPC/GB14/081	United Kingdom		PRODUCT NAME: TRAMETINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/14/931(01-06) 20140702
1761528	C20140036 00120	Estonia		CHANGE OF OWNER'S ADDRESS

DABRAFENIB MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dabrafenib Mesylate

Introduction

Dabrafenib mesylate, marketed under the brand name Tafinlar, is a potent and selective Raf kinase inhibitor used primarily in the treatment of various cancers, including melanoma, anaplastic thyroid cancer, and non-small cell lung cancer, particularly those with BRAF V600E or V600K mutations. Here, we delve into the market dynamics and financial trajectory of this crucial oncology drug.

Approval and Regulatory Landscape

Dabrafenib mesylate was approved by the FDA on May 29, 2013, for the treatment of melanoma with V600E or V600K mutations. Subsequent approvals have expanded its use to include anaplastic thyroid cancer and other solid tumors in combination with trametinib[2][5].

Therapeutic Indications

The drug is used in several cancer types:

• Melanoma: Alone or in combination with trametinib for patients whose cancer cannot be removed by surgery or has spread.
• Anaplastic Thyroid Cancer: In combination with trametinib for locally advanced or metastatic disease.
• Non-Small Cell Lung Cancer: In combination with trametinib for metastatic disease with BRAF V600E mutations.
• Solid Tumors: In combination with trametinib for adults and children aged 6 years and older with tumors that cannot be removed by surgery or have spread[2].

Market Performance

Revenue Growth

The revenue of dabrafenib mesylate has shown significant growth since its launch:

• 2013-2014: The drug saw a new launch phase with revenues of $743.80 million in 2014.
• 2015-2016: Revenue increased to $672 million, reflecting a 48% growth from the previous year.
• 2017-2018: The revenue continued to rise, reaching $1,155 million in 2018, a 32% increase from 2017.
• 2019-2020: The revenue was $1,338 million in 2019 and $1,542 million in 2020, showing a 15% growth.
• 2021-2023: The trend continued with revenues of $1,693 million in 2021, $1,770 million in 2022, and $1,922 million in 2023, indicating growth rates of 10%, 5%, and 9%, respectively[1].

Market Share and Competition

Dabrafenib mesylate, often used in combination with trametinib, competes in a market dominated by targeted therapies for BRAF-mutated cancers. The combination of dabrafenib and trametinib has been shown to be superior to other treatments like vemurafenib alone, contributing to its market share[3].

Cost-Effectiveness and Pricing

Economic Impact

The cost-effectiveness of dabrafenib mesylate, particularly when used in combination with trametinib, has been a subject of study. A cost-effectiveness analysis in Switzerland indicated that while the combination therapy offers clinical benefits, it is not cost-effective at current US prices, requiring a reduction in total price to achieve an acceptable cost-effectiveness ratio[3].

Pricing and Access

The high cost of dabrafenib mesylate can be a barrier to access. For instance, the estimated additional cost of treatment with trametinib plus dabrafenib was around CHF 199,647 (Swiss francs), which is significant and may not be feasible for many healthcare systems without price adjustments[3].

Clinical Trials and Research

Ongoing Studies

Dabrafenib mesylate is continuously being studied in various clinical trials to expand its indications and improve treatment outcomes. These trials include investigations into its efficacy in other types of cancer and in combination with other therapies[2].

Research Findings

Research has shown that the combination of dabrafenib and trametinib is more effective than monotherapy in treating BRAF-mutated melanoma, leading to improved survival rates and quality of life. For example, studies have highlighted the superiority of this combination in achieving better response rates and prolonging progression-free survival[2][3].

Patient Impact and Quality of Life

Quality-Adjusted Life Years (QALYs)

The treatment with dabrafenib and trametinib has been estimated to yield a gain of 0.52 QALYs, indicating a significant improvement in the quality of life for patients with metastatic melanoma[3].

Side Effects and Tolerability

While dabrafenib mesylate is generally well-tolerated, it can have side effects such as skin rash, fever, and fatigue. However, the benefits of the treatment often outweigh these adverse effects, especially in patients with limited treatment options[2].

Future Outlook

Market Expansion

The market for dabrafenib mesylate is expected to continue growing as more patients are diagnosed with BRAF-mutated cancers and as the drug's use expands into other indications.

Competitive Landscape

The competitive landscape is likely to evolve with the introduction of new targeted therapies. However, the established efficacy and safety profile of dabrafenib mesylate, particularly in combination with trametinib, positions it strongly in the market.

Key Takeaways

• Revenue Growth: Dabrafenib mesylate has shown consistent revenue growth since its launch, driven by its efficacy in treating BRAF-mutated cancers.
• Therapeutic Indications: The drug is approved for various cancer types, including melanoma, anaplastic thyroid cancer, and non-small cell lung cancer.
• Cost-Effectiveness: While clinically beneficial, the combination therapy with trametinib requires price adjustments to be cost-effective.
• Clinical Trials: Ongoing research aims to expand its indications and improve treatment outcomes.
• Patient Impact: The treatment significantly improves quality of life, as evidenced by QALY gains.

FAQs

What is dabrafenib mesylate used for?

Dabrafenib mesylate is used to treat various cancers, including melanoma, anaplastic thyroid cancer, and non-small cell lung cancer, particularly those with BRAF V600E or V600K mutations.

How effective is dabrafenib mesylate in combination with trametinib?

The combination of dabrafenib and trametinib has been shown to be superior to monotherapy in treating BRAF-mutated melanoma, leading to improved survival rates and quality of life.

What are the common side effects of dabrafenib mesylate?

Common side effects include skin rash, fever, and fatigue, but the benefits of the treatment often outweigh these adverse effects.

Is dabrafenib mesylate cost-effective?

While clinically beneficial, the combination therapy with trametinib is not cost-effective at current US prices and requires a reduction in total price to achieve an acceptable cost-effectiveness ratio.

What is the future outlook for dabrafenib mesylate in the market?

The market for dabrafenib mesylate is expected to continue growing as more patients are diagnosed with BRAF-mutated cancers and as the drug's use expands into other indications.

Sources

1. PharmaCompass: Dabrafenib Mesylate | Annual Sales Report.
2. National Cancer Institute: Dabrafenib Mesylate.
3. PubMed: A cost-effectiveness analysis of trametinib plus dabrafenib.
4. R&D Systems: Dabrafenib mesylate | Raf Kinase Inhibitors.
5. DrugBank: Dabrafenib mesylate.