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 eighty-six patent family members in forty-seven countries.

There is one drug master file entry for dabrafenib mesylate. One supplier is listed for this compound.

Summary for DABRAFENIB MESYLATE

International Patents:	186
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:	15
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

Dosage:

CAPSULE;ORAL

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
Rising Tide Foundation	PHASE2
University of California, San Francisco	PHASE2
ECOG-ACRIN Cancer Research Group	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					Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes					Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes

International Patents for DABRAFENIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Poland	3560498
Australia	2009244491
South Africa	201007960	BENZENE SULFONAMIDE THIAZOLE AND OXAZOLE COMPOUNDS

Supplementary Protection Certificates for DABRAFENIB MESYLATE

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	PA2014039	Lithuania		PRODUCT NAME: TRAMETINIBUM; 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

Last updated: October 5, 2025

rket Dynamics and Financial Trajectory for DABRAFENIB MESYLATE

Introduction
Dabrafenib Mesylate (brand name: Tafinlar) is a targeted therapy designed to inhibit BRAF V600 mutations, primarily in melanoma and several other solid tumors. Its market trajectory reflects the expanding scope of precision oncology, driven by increasing biomarker-driven treatment adoption and evolving healthcare policies. Understanding the market dynamics and financial trends for dabrafenib mesylate provides insight into its commercial potential, competitive landscape, and strategic positioning within oncology therapies.

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Pharmacological Profile and Clinical Indications
Dabrafenib mesylate is a selective inhibitor of mutant BRAF kinase, a critical driver in tumor cell proliferation. Approved initially for BRAF V600E-mutant metastatic melanoma, its indication base has since expanded to include non-small cell lung cancer (NSCLC), thyroid cancer, and other solid tumors harboring BRAF mutations, under emerging or off-label use and clinical trial support. This multi-indication landscape ensures a broad growth platform, especially considering the growing incidence of BRAF-mutant cancers globally.

Market Drivers
Key drivers fueling the demand for dabrafenib mesylate include:

• Precision Oncology Adoption: The shift toward tailored treatments aligns with increased molecular testing for BRAF mutations across various cancers. Advances in companion diagnostics enhance the identification of eligible patient populations, directly boosting drug uptake.

• Expanding Clinical Evidence: Robust clinical trial results demonstrating improved progression-free and overall survival have strengthened regulatory approvals and physicians’ confidence, expanding indications and positioning dabrafenib as a standard-of-care for suitable patients.

• Combination Therapies: Combining dabrafenib with MEK inhibitors (e.g., trametinib) has shown superior efficacy, leading to combination therapies becoming preferred treatment protocols. These combinations tend to command premium pricing, elevating revenue streams.

• Healthcare Policy and Reimbursement: Progressive reimbursement strategies across markets such as the U.S., Europe, and emerging economies facilitate access, positively impacting sales trajectories. Favorable policies supporting molecular testing further reinforce growth prospects.

• Rising Global Incidence of Targeted Cancers: Increasing prevalence of melanoma, NSCLC, and thyroid cancers, especially in aging populations, sustains long-term demand.

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Market Challenges and Barriers

• Competitive Pressure: The BRAF and MEK inhibitor market is intensely competitive, with treatments like vemurafenib, encorafenib, and combinations including pembrolizumab, exerting pricing and market share pressures.

• Pricing and Cost-Effectiveness: High treatment costs raise concerns regarding affordability and payer reimbursement restrictions, especially in cost-sensitive healthcare systems.

• Biomarker Testing Limitations: Despite advances, inconsistent access to comprehensive molecular testing hampers the identification of eligible patients, limiting market penetration.

• Emerging Resistance: Tumor resistance to BRAF inhibition remains an obstacle, necessitating ongoing combination innovations and novel agents, which could alter market dynamics over the long term.

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Financial Trajectory and Revenue Forecasts

Historical Performance
Since its market launch around 2013, dabrafenib mesylate has demonstrated strong initial growth, fueled by melanoma indications. According to IQVIA data, global sales reached approximately $800 million in 2021, with sustained growth driven by expanding indications and combination regimens.

Projected Growth Trends
Industry forecasts project a compound annual growth rate (CAGR) of 10-12% over the next five years, driven by:

• Broader indication expansion into NSCLC and thyroid cancers, supported by ongoing clinical trials demonstrating efficacy.

• Increased utilization of companion diagnostics and biomarker testing that facilitate patient stratification.

• Uptake of combination regimens, which tend to command higher prices, thereby substantially increasing per-patient revenue.

Market Penetration in Emerging Economies
Although high-income countries dominate initial sales, emerging markets like China, India, and Brazil exhibit growing adoption, supported by rapid healthcare infrastructure development and governmental initiatives promoting advanced cancer therapies. These markets, however, may face pricing and reimbursement challenges, impacting overall revenue trajectories.

Pricing Strategies
Pricing strategies align with the targeted nature of dabrafenib, often positioned as premium treatments. The average wholesale price (AWP) for dabrafenib monotherapy in the U.S. is roughly $10,000–$15,000 per month, with combination therapies exceeding $20,000. Payer negotiations and patient assistance programs significantly influence net revenue.

Impact of Patent Expirations and Biosimilar Entry
Dabrafenib’s patent protection extends into the late 2020s, with potential biosimilar entry in the early 2030s. Such developments could exert downward pressure on prices and market share, emphasizing the need for lifecycle management strategies, including expanding indications and developing next-generation inhibitors.

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Strategic Landscape and Competitive Positioning

Key Competitors

• Vemurafenib (Zelboraf): Approved for BRAF V600E-mutant melanoma.
• Encorafenib (Braftovi): Approved for melanoma with BRAF V600E or V600K mutations.
• Combination regimens: BRAF inhibitors paired with MEK inhibitors (e.g., cobimetinib, trametinib) dominate the clinical landscape.

Differentiators of Dabrafenib

• Favorable safety profile and manageable side effects.
• Favorable pharmacokinetics allowing flexible dosing schedules.
• Broad indication expansion supported by ongoing clinical trials.

Partnerships and Mergers & Acquisitions
Strategic alliances with diagnostic developers and biopharmaceutical companies facilitate market reach and innovation. For example, partnership with Roche (through Genentech) for companion diagnostics has enhanced patient selection accuracy.

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Regulatory and Market Expansion Outlook

• Regulatory Approvals: Ongoing submissions for additional indications, including NSCLC and other solid tumors, are expected to broaden the market base.

• Market Access Initiatives: Engagement with health authorities on value-based pricing and outcome-based contracts could optimize reimbursement and expand access.

• Investment in Biomarker and Combination Therapy Research: Accelerating research enhances sensitivity to resistance mechanisms and improves combination strategies, further elevating dabrafenib’s positioning.

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Key Takeaways

• The global dabrafenib mesylate market exhibits robust growth driven by expanding indications, combination therapies, and precision medicine trends.
• Competitive Airspace remains intense, with pricing pressures and resistance phenomena posing challenges but also opportunities for innovation.
• Revenue growth is expected to average around 10-12% CAGR over the next five years, influenced by clinical pipeline progress and market expansion, notably into emerging economies.
• Lifecycle strategies, including indication expansion, partnership development, and biosimilar planning, are critical for sustained profitability.
• Policy shifts favoring value-based care and diagnostic-driven treatment approaches will shape the future trajectory.

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FAQs

1. What are the primary indications for dabrafenib mesylate currently?
Dabrafenib is approved mainly for BRAF V600E-mutant metastatic melanoma and, in combination with MEK inhibitors, for melanoma and NSCLC harboring BRAF mutations. Future approvals may extend its use to other solid tumors based on ongoing clinical trials.

2. How does dabrafenib mesylate compare clinically to other BRAF inhibitors?
Dabrafenib offers a favorable safety profile, flexible dosing, and established efficacy, especially in combination regimens. While other inhibitors like vemurafenib are comparable, dabrafenib’s additional indications and combination strategies provide competitive advantages.

3. What factors will influence the market growth of dabrafenib mesylate?
Key factors include the expansion of indications, improvements in molecular diagnostics, adoption of combination therapies, regulatory approvals, and pricing/reimbursement environments. Resistance mechanisms and biosimilar entry will also impact growth.

4. What are the main challenges in the commercialization of dabrafenib?
Major challenges include market competition, high drug pricing, limited access to molecular testing in some regions, potential resistance by tumors, and upcoming biosimilar competition.

5. How significant is the impact of emerging therapies on dabrafenib’s market share?
Emerging targeted therapies and immune checkpoint inhibitors could challenge dabrafenib’s market share, especially if they demonstrate superior efficacy, safety, or cost-effectiveness. An emphasis on combination approaches may help maintain its position.

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Sources

1. IQVIA. (2022). Global Oncology Market Data.
2. FDA. (2018-2022). Drug Approvals and Indications for Dabrafenib.
3. GlobalData. (2023). Oncology Drug Market Forecasts.
4. ClinicalTrials.gov. (2023). Ongoing Trials for BRAF-Mutant Cancers.
5. European Medicines Agency. (2022). Regulatory Decisions on Dabrafenib.

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Conclusion
Dabrafenib mesylate stands at the forefront of targeted oncology, with a promising market trajectory driven by biological rationale and expanding indications. Strategic development and careful navigation of competitive and reimbursement environments are essential for maximizing its market potential. Continuous innovation and pipeline expansion will shape its long-term financial outlook, ensuring its sustained role in precision cancer therapy.