encorafenib - Profile

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-nine patent family members in fifty-three countries.

Summary for encorafenib

International Patents:	199
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for encorafenib

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

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.

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
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No			Y	Y
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

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
Cyprus	1117667
Mexico	353446	FORMULACIONES FARMACEUTICAS. (PHARMACEUTICAL FORMULATIONS.)
Japan	6045519
Japan	2015501808	医薬製剤

Supplementary Protection Certificates for encorafenib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	LUC00101	Luxembourg		PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924
2470526	CR 2019 00012	Denmark		PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/18/1314, 2018-09-24; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; PRV HAR I BESLUT DEN 8 JULI 2025 RAETTAT SKYDDSTIDEN I FOELJANDE TILLAEGGSSKYDD I ENLIGHET MED PMD:S BESLUT PMAE 7804/24: 2290016-1, 2090020-5, 2090055-1, 1590060-8, 1890030-8, 1990012-5, 2190017-0, 1690040-9, 1790035-8, 2390005-3, 1990013-3, 2090009-8
2470526	2019/012	Ireland		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/18/1314 20180924

Encorafenib Market Analysis and Financial Projection

Last updated: February 10, 2026

What Is the Investment Case for Encorafenib?

Encorafenib is a BRAF inhibitor developed primarily for melanoma patients harboring BRAF V600E/K mutations. Market prospects hinge on its approval status, competitive positioning against alternatives like vemurafenib or dabrafenib, and the broader landscape of targeted melanoma therapies.

Market Size and Revenue Potential. The global melanoma treatment market was valued at approximately $900 million in 2021 and is projected to grow at a CAGR of 8-10%, driven by increasing incidence rates and broader adoption of targeted therapies[1]. Encorafenib's key indication, BRAF-mutant melanoma, accounts for around 50% of melanoma cases.

Regulatory Status. Approved in the U.S. and Europe for BRAF V600E/K melanoma, under licensing agreements between Bayer and Dasatinib (as of 2020). Its commercial potential depends on market penetration relative to established therapies.

What Are Encorafenib’s Core Pharmacological and Clinical Characteristics?

Mechanism of Action. Encorafenib selectively inhibits BRAF kinase activity, disrupting MAPK pathway signaling in BRAF-mutated cancer cells. It demonstrates high potency with an IC50 of approximately 0.7 nM, and selectivity minimizes off-target effects.

Clinical Trial Data. Phase III COLUMBUS trial showed that encoafenib combined with binimetinib improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy and monotherapy:

• PFS: 14.9 months (combo) vs. 7.3 months (monotherapy)

• OS: 33.6 months (combo) vs. 16.9 months (monotherapy)[2]

These results compare favorably with data for competitors such as dabrafenib and vemurafenib.

How Does Encorafenib Position Against Competitors?

Drug	Approval Year	Indications	PFS (months)	OS (months)	Dosage
Encorafenib+binimetinib	2018 (FDA)	Melanoma (BRAF V600E/K)	14.9	33.6	Once daily + twice daily
Vemurafenib	2011	Melanoma	6.9	13.6	Twice daily
Dabrafenib	2013	Melanoma	5.5	16.6	Twice daily

Encorafenib’s combination demonstrates longer PFS and OS, but actual market share depends on approval breadth, cost, and clinician preference.

What Are the Key Economic and Regulatory Risks?

• Market Competition: Vemurafenib and dabrafenib already hold significant market share, with both having multiple combination therapies approved. Entry barriers include established clinical protocols and payer coverage.

• Pricing and Reimbursement: Encorafenib's pricing must justify its incremental benefits over competitors. Reimbursement policies influence adoption.

• Regulatory Approvals: Additional indications for other cancers like colorectal cancer (in combination with cetuximab) are under investigation. Regulatory delays could impede growth.

• Patent Landscape and Generic Entry: Patent expiry around 2028 poses long-term risks. Generic versions could erode margins.

What Are the Underlying R&D and Intellectual Property Dynamics?

• Patent Portfolio: The core composition patent is filed through Bayer, with key expiration expected around 2028-2029. Patent extensions for specific formulations or combinations are possible.

• R&D Pipeline: Bayer is exploring encoafenib’s efficacy in other BRAF-mutant cancers, including colorectal cancer and thyroid carcinoma. Success could diversify revenue sources and extend patent protection.

• Companion Diagnostics: Development of BRAF mutation testing assays has certified commercial viability, influencing market uptake.

What Are the Strategic Opportunities for Investors?

• Combination Therapies: Co-developments with MEK, CDK4/6, or immune checkpoint inhibitors could enhance efficacy, creating higher-value treatment options.

• Expanding Indications: Moving into colorectal or non-melanoma cancers could unlock new revenue streams.

• Market Penetration: Partnering with payers and clinicians to expand access in emerging markets.

• Lifecycle Management: Updates to dosing, formulations, or combination regimes can extend patent life.

What Are the Key Shortcomings or Challenges?

• Competitive Pressure: Existing drugs have established market presence, and new entrants like immune checkpoint inhibitors challenge targeted therapies.

• Efficacy Ceiling: While superior in certain metrics, overall survival benefits are modest relative to broader immunotherapies.

• Cost-Effectiveness: The incremental benefit over other BRAF inhibitors must be clearly demonstrated for payer acceptance.

Summary of Investment Fundamentals

• The drug has demonstrated efficacy in pivotal trials, with a favorable safety profile.

• Commercial success depends on competitive positioning, market access, and additional indications.

• Patent expiry and emerging competition from immunotherapies pose long-term risks.

• Ongoing clinical trials could extend life cycle and diversify applications.

Key Takeaways

• Encorafenib’s core strength lies in its efficacy for BRAF-mutant melanoma, showing improvements over monotherapy.

• Its market penetration will depend heavily on competitive dynamics, especially against vemurafenib and dabrafenib.

• The expiration of patents around 2028 presents potential for generic entry, influencing long-term profitability.

• Expansion into other cancers and combination strategies represent crucial growth opportunities.

• The competitive landscape's evolution requires continuous R&D investment and strategic licensing.

FAQs

1. How does Encorafenib compare to other BRAF inhibitors in terms of efficacy?
It demonstrates longer PFS and OS in combination therapy compared to earlier BRAF inhibitors like vemurafenib and dabrafenib. Clinical trial data support a superior safety profile and durability of response.

2. What are the primary regulatory hurdles for expanding Encorafenib’s indications?
Regulatory approval depends on positive results from ongoing trials in colorectal and thyroid cancers, alongside demonstration of safety and efficacy at relevant doses.

3. What is the significance of patent expirations for Encorafenib?
Patents in the U.S. and Europe are expected to expire around 2028-2029, after which generic competition could reduce pricing and market share unless new patents or formulations are secured.

4. Can Encorafenib be combined with immunotherapies?
Investigational trials are assessing combinations with immune checkpoint inhibitors like pembrolizumab. Success could significantly broaden its therapeutic scope and market potential.

5. What is the outlook for Encorafenib's use in non-melanoma cancers?
Preliminary data suggest promise in BRAF-mutant colorectal and thyroid cancers. Positive trial outcomes could open new market opportunities and extend its commercial lifecycle.

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Sources
[1] MarketResearch.com, "Global Melanoma Market Report," 2022.
[2] European Medicines Agency (EMA), "Encorafenib Summary of Product Characteristics," 2022.