Encorafenib - Generic Drug Details

What are the generic drug sources for encorafenib and what is the scope of freedom to operate?

Encorafenib is the generic ingredient in one branded drug marketed by Array Biopharma Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Encorafenib has one hundred and ninety-eight patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for encorafenib

International Patents:	198
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	75
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for encorafenib
What excipients (inactive ingredients) are in encorafenib?	encorafenib excipients list
DailyMed Link:	encorafenib at DailyMed

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

Constraining patent/regulatory exclusivity:

9,474,754

Dosage:

CAPSULE;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 encorafenib

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

Sponsor	Phase
SRH Wald-Klinikum Gera GmbH	PHASE4
Pierre Fabre Pharma GmbH	PHASE4
Regeneron Pharmaceuticals	PHASE2

See all encorafenib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for encorafenib

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

Paragraph IV (Patent) Challenges for ENCORAFENIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRAFTOVI	Capsules	encorafenib	75 mg	210496	3	2022-06-27

US Patents and Regulatory Information for encorafenib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	9,763,941
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	10,258,622
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	9,314,464

EU/EMA Drug Approvals for encorafenib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Braftovi	encorafenib	EMEA/H/C/004580Encorafenib is indicated:in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutationin combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy	Authorised	no	no	no	2018-09-19

International Patents for encorafenib

Country	Patent Number	Title	Estimated Expiration
Mexico	2014006278	FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.)
Poland	2782557
Ukraine	112285	СПОЛУКИ ТА КОМПОЗИЦІЯ ЯК ІНГІБІТОРИ ПРОТЕЇНКІНАЗИ (COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS)
European Patent Office	3449911	FORMULATIONS PHARMACEUTIQUES (PHARMACEUTICAL FORMULATIONS)
Poland	2470526

Supplementary Protection Certificates for encorafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2727918	300975	Netherlands		PRODUCT NAME: COMBINATIE VAN BINIMETINIB EN ENCORAFENIB, BEIDE IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/18/1314 20180924
2727918	CA 2019 00013	Denmark		PRODUCT NAME: KOMBINATION AF BINIMETINIB OG ENCORAFENIB, I ALLE FORMER HVERT ISAER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 ELLER EU/1/18/1314 20180924
2470526	C02470526/01	Switzerland		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
2727918	16/2019	Austria		PRODUCT NAME: KOMBINATION AUS BINIMETINIB UND ENCORAFENIB, JEWEILS IN ALLEN FORMEN EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/18/1314 EU/1/18/1315 (MITTEILUNG) 20180924
2470526	PA2019005	Lithuania		PRODUCT NAME: ENKORAFENIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1314 20180920

Last updated: July 28, 2025

rket Dynamics and Financial Trajectory for Encorafenib

Introduction

Encorafenib is a targeted anti-cancer therapy classified as a selective BRAF kinase inhibitor. Authorized for use primarily in BRAF V600E-mutant metastatic melanoma, it has expanded its indications into other malignancies such as colorectal cancer. Its development journey, regulatory milestones, and market potential demonstrate evolving complexities aligned with advancements in precision oncology. Analyzing its market dynamics and financial trajectory offers strategic insights for stakeholders across biotech and pharmaceutical sectors.

Development Background and Regulatory Milestones

Encorafenib, developed by Novartis, received its first regulatory approval in 2018 for the treatment of unresectable or metastatic BRAF V600E-mutant melanoma, in combination with binimetinib, a MEK inhibitor (FDA, 2018). Regulatory endorsements followed in Europe and other jurisdictions, affirming its therapeutic value. The pivotal COLUMBUS trial demonstrated improved median overall survival (OS) in combination therapy over chemotherapy or monotherapy options, fueling its commercial viability.

Subsequently, in 2020, FDA expanded its approval to include BRAF-mutant metastatic colorectal cancer when used with cetuximab, reflecting an adaptive response to emerging clinical data. Continued research into additional oncologic indications positions encorafenib as a versatile agent in the precision medicine landscape.

Market Size and Competitive Landscape

Market Overview

The global targeted oncology market is projected to reach US$140 billion by 2026, growing at a CAGR of roughly 8% (Research and Markets, 2022). BRAF inhibitors like encorafenib occupy a significant niche within this expanding segment, driven by rising prevalence of melanoma and colorectal cancer globally. Melanoma incidence alone is expected to reach 324,000 cases worldwide in 2022, underpinning steady patient demand.

Competitive Profile

Key competitors include vemurafenib (Genentech/Roche), dabrafenib (GlaxoSmithKline), and sorafenib (Bayer). While vemurafenib and dabrafenib were pioneers, encorafenib offers specific advantages, such as a favorable safety profile and extended progression-free survival (PFS) in combination regimens. The combination therapy with binimetinib has been positioned as a differentiation factor, especially in first-line treatment of BRAF-mutant melanoma.

Emerging competitors venture into similar molecular pathways or novel targets, necessitating continual strategic innovation and lifecycle management.

Market Dynamics Influencing Trajectory

Clinical Efficacy and Safety Profile

Clinical trial data have underpinned encorafenib's market penetration. Its efficacy in improving OS and PFS, combined with manageable adverse events, has favored its adoption. Real-world evidence continues to validate clinical trial findings, which in turn influences prescribing patterns and reimbursement policies.

Regulatory Expansions and Labeling

Expanded approvals, such as for colorectal cancer, broaden its potential revenue base. The regulatory landscape remains receptive but increasingly focused on biomarkers, necessitating companion diagnostics development to optimize patient selection. This alignment enhances product value but adds complexity to commercialization strategies.

Pricing and Reimbursement Strategies

Pricing remains competitive, balancing franchise value against pressure to lower costs in healthcare systems worldwide. Reimbursement success hinges on demonstrated clinical benefit and comparative advantage. Renegotiation of formulary placements and payer negotiations are ongoing processes influencing market penetration.

Manufacturing and Supply Chain

High-quality manufacturing is vital to prevent supply disruptions that could impair market share. Novartis’s established manufacturing capabilities support consistent supply, bolstering market confidence.

Financial Trajectory Projections

Revenue Generation

Forecasts estimate encorafenib’s global sales will reach US$1.2 billion by 2030, driven by growth in melanoma and colorectal cancers. Initial revenues in the US constituting approximately 50% of sales reflect its strong domestic presence, with European and Asia-Pacific markets expanding rapidly due to increasing cancer incidences (IQVIA, 2022).

Market Penetration and Licenses

Strategic licensing deals with regional pharmaceutical firms facilitate localized commercialization, especially in emerging markets. Expansion into additional indications—such as non-small cell lung cancer and other BRAF-mutant tumors—may enhance revenue streams.

Research and Development Investment

Ongoing pipeline investments aim to enhance efficacy, reduce resistance, and identify new combination therapies. The R&D budget for encorafenib exceeds US$200 million annually, supporting clinical trials that may unlock further indications, thus positively impacting future revenues.

Profitability Outlook

Gross margins are projected to remain above 70%, considering cost-efficient manufacturing and high pricing power due to clinical uniqueness. Net profitability margins could approach 30% by 2025, assuming positive outcomes from pipeline expansion and maintained market share.

Market Risks and Opportunities

Risks

• Competitive pressure from established and upcoming BRAF inhibitors.
• Regulatory hurdles in approval for novel indications or combination regimens.
• Pricing pressures amidst healthcare cost containment efforts.
• Resistance development in tumor cells, necessitating combination therapies that may increase complexity and costs.

Opportunities

• Broadening indications into other BRAF-mutant malignancies.
• Combination strategies with immunotherapies to enhance efficacy.
• Biomarker innovations to optimize patient selection, increasing treatment success rates.
• Geographic expansion to emerging markets with rising cancer prevalence.

Strategic Outlook for Stakeholders

Companies should leverage real-world evidence and invest in biomarker-driven clinical trials to sustain competitive advantages. Collaborations with diagnostics firms can accelerate personalized treatment protocols, improving market penetration. Additionally, diversification into other oncology segments will dilute risk and stabilize long-term revenues.

Key Takeaways

• Encorafenib's targeted approach and combination therapy positioning foster a strong growth trajectory within the oncology market.
• Expanding indications, including colorectal and potentially other solid tumors, present substantial revenue opportunities.
• Competitive dynamics necessitate continuous innovation, strategic licensing, and aggressive market expansion.
• Pricing and reimbursement strategies will significantly influence financial outcomes amid uniform healthcare cost pressures.
• Ongoing clinical research and biomarker development are critical for maintaining encorafenib’s edge and prolonging lifecycle value.

FAQs

1. What are the primary indications for encorafenib?
Encorafenib is primarily approved for BRAF V600E-mutant metastatic melanoma and BRAF-mutant metastatic colorectal cancer in combination with cetuximab.

2. How does encorafenib compare to other BRAF inhibitors?
It offers comparable or superior efficacy with a potentially better safety profile and is often used in combination therapies, particularly with binimetinib, differentiating it from competitors like vemurafenib and dabrafenib.

3. What are the major challenges facing encorafenib's market growth?
Key challenges include emerging resistance, pricing pressures, competition from existing and novel therapies, and regulatory hurdles for new indications.

4. How significant is the pipeline development for encorafenib?
Pipeline efforts focus on combination strategies, additional solid tumor indications, and biomarker-based patient selection, all critical for sustaining growth and expanding market share.

5. What is the growth outlook for encorafenib over the next decade?
With expanding indications, geographic penetration, and continued clinical innovation, encorafenib is poised for steady growth, projecting sales to reach approximately US$1.2 billion globally by 2030.

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Sources
[1] FDA Approval Announcement, 2018.
[2] Research and Markets, 2022. Global Oncology Market Report.
[3] IQVIA, 2022. Oncology Market Dynamics.