BINIMETINIB - Generic Drug Details

What are the generic sources for binimetinib and what is the scope of patent protection?

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

Binimetinib has two hundred and thirty-one patent family members in fifty-five countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for BINIMETINIB

International Patents:	231
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	98
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BINIMETINIB
What excipients (inactive ingredients) are in BINIMETINIB?	BINIMETINIB excipients list
DailyMed Link:	BINIMETINIB at DailyMed

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

Dosage:

TABLET;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 BINIMETINIB

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

Sponsor	Phase
SRH Wald-Klinikum Gera GmbH	PHASE4
Pierre Fabre Pharma GmbH	PHASE4
Grupo Espaol Multidisciplinar de Melanoma	PHASE2

See all BINIMETINIB clinical trials

Generic filers with tentative approvals for BINIMETINIB

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET
		15MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for BINIMETINIB

L01EE	Mitogen-activated protein kinase (MEK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BINIMETINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEKTOVI	Tablets	binimetinib	45 mg	210498	1	2025-06-26
MEKTOVI	Tablets	binimetinib	15 mg	210498	3	2022-06-27

US Patents and Regulatory Information for BINIMETINIB

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	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes			Y	Y
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes

Expired US Patents for BINIMETINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018

EU/EMA Drug Approvals for BINIMETINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Mektovi	binimetinib	EMEA/H/C/004579Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	Authorised	no	no	no	2018-09-20

International Patents for BINIMETINIB

Country	Patent Number	Title	Estimated Expiration
Guatemala	201200053	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA
Hong Kong	1167390
China	101633644	N3 alkylated benzimidazole derivatives as mek inhibitors
Cyprus	1109727
New Zealand	535158	N3 alkylated benzimidazole derivatives as MEK inhibitors
Hong Kong	1141976	N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS
Eurasian Patent Organization	201500175	СОЕДИНЕНИЯ И КОМПОЗИЦИИ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗ

Supplementary Protection Certificates for BINIMETINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	SPC/GB19/007	United Kingdom		PRODUCT NAME: BINIMETINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1315/001-002 20180920
2470526	C02470526/01	Switzerland		PRODUCT NAME: ENCORAFENIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66795 01.11.2019
1482932	C20190010 00281	Estonia		PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018
2470526	1990012-5	Sweden		PRODUCT NAME: ENCORAFENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF; REG. NO/DATE: EU/1/18/1314 20180924
2727918	C20190009	Finland		TZ1Y, PARTY DATA CHANGE RELATED TO A GRANTED SPC
2470526	CR 2019 00012	Denmark		PRODUCT NAME: ENCORAFENIB ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/18/1314 20180924
2727918	LUC00102	Luxembourg		PRODUCT NAME: COMBINAISON DE BINIMETINIB ET D'ENCORAFENIB, CHACUN SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1314 20180924

Market Dynamics and Financial Trajectory for Binimetinib

Last updated: July 27, 2025

Introduction

Binimetinib, marketed under the brand name Mektovi, is a selective MEK inhibitor developed primarily for the treatment of certain cancers, notably melanoma with BRAF V600 mutations. As targeted cancer therapies grow in prominence, understanding the market forces and financial outlook for binimetinib offers strategic insights for stakeholders. This analysis explores the drug’s current market landscape, competitive positioning, regulatory environment, and revenue trajectory, providing a comprehensive outlook grounded in recent trends and data.

Pharmacological Profile and Clinical Landscape

Binimetinib inhibits MEK1 and MEK2, kinase enzymes integral to the MAPK/ERK signaling pathway, which is often dysregulated in cancers. Its approval by the U.S. Food and Drug Administration (FDA) in 2018, in combination with encorafenib (a BRAF inhibitor), for melanoma patients harboring BRAF V600 mutations, marked a significant milestone [1]. The combination therapy demonstrated improved progression-free survival (PFS) compared to monotherapy, aligning with the shift towards combination regimens in oncology.

The drug’s clinical development also spans other tumor types, including colorectal and ovarian cancers, though with varying success. The niche focus on BRAF-mutant melanoma anchors binimetinib within the targeted therapy segment, where precision medicine commands premium pricing and strong clinician interest.

Market Drivers and Influencing Factors

Growing Prevalence of BRAF-Mutant Melanoma

The global incidence of melanoma with BRAF V600 mutations underscores the demand for targeted therapies. According to the American Cancer Society, approximately 50% of melanoma cases harbor BRAF mutations, with BRAF V600E being the predominant variant [2]. Rising diagnosis rates elevate the potential patient pool, amplifying demand for approved treatment options like binimetinib.

Advancements in Precision Oncology

The shift from conventional chemotherapies to targeted agents has heightened the appeal of drugs like binimetinib. Its approval as part of combination therapy with encorafenib reflects clinical confidence in kinase inhibitors’ ability to prolong survival and improve quality of life, thus fueling market enthusiasm.

Competitive Landscape

Binimetinib’s primary competitor is dabrafenib combined with trametinib, a well-established BRAF-MEK inhibitor duo that has captured substantial market share since approval in 2013 [3]. Moreover, other emerging therapies, such as encorafenib plus binimetinib (its own combination partner), introduce competitive pressures, emphasizing the importance of clinical differentiation, pricing strategies, and physician preference.

Regulatory and Reimbursement Environment

FDA and EMA approvals create the regulatory backbone, but reimbursement policies significantly influence market penetration. Positive health technology assessments (HTAs) in major markets bolster uptake, whereas reimbursement hurdles and high drug prices can impede sales growth.

Market Access and Patient Adoption

Physician familiarity, clinical guidelines endorsing combination therapy, and patient access programs serve as catalysts for sustained adoption. Conversely, adverse events, such as skin toxicity and cardiomyopathy associated with MEK inhibitors, can impact prescribing patterns.

Financial Trajectory and Revenue Forecasts

Historical Sales Data and Current Position

Since its approval, binimetinib has demonstrated modest yet steady sales, largely confined to melanoma indications. In 2021, its global sales were estimated at approximately $150 million, according to IQVIA data, reflecting limited market penetration as a niche therapy [4].

Forecasting Factors

• Market Penetration and Expansion: Broader adoption within melanoma treatment regimens and exploration in other indication areas can unlock revenue potential. Continued clinical trials may extend the drug’s label, enhancing its commercial footprint.
• Geographical Growth: While the U.S. remains the primary market, expanding to Europe, Asia-Pacific, and emerging markets offers additional growth avenues, contingent on regulatory approvals and market access strategies.
• Pricing and Discount Trends: Premium pricing sustains revenue, but price pressures from payers and competition may erode margins over time.
• Pipeline and Combination Strategies: Synergistic combinations with other agents and potential maintenance therapies could generate incremental sales, especially if supported by positive clinical outcomes.

Projected Revenue Outlook (2023-2030)

A conservative estimate suggests that binimetinib’s annual sales could grow to approximately $300–$400 million by 2025, driven by increased adoption and geographic expansion. Long-term growth prospects hinge on securing new indications, optimizing dosing regimens, and maintaining alignment with evolving clinical guidelines. By 2030, with possible label extensions and inclusion in broader combination regimens, peak revenues could reach $500 million to $1 billion, particularly if clinical trials validate additional efficacy in resistant or refractory melanoma cases.

Market Challenges and Risks

• Intense Competition: The dominance of existing BRAF-MEK inhibitor combinations constrains market share growth.
• Efficacy and Safety Profiles: Adverse events or marginal clinical benefits could restrict usage, particularly if competing therapies demonstrate superior outcomes.
• Regulatory Setbacks: Delays or denials in approval for new indications can diminish growth prospects.
• Patent Expirations: Loss of exclusivity would open pathways for generics or biosimilars, pressuring prices and revenues.

Strategic Opportunities

• Label Expansion: Trials in non-melanoma tumors and resistant disease could forge pathways for additional approvals.
• Combination Regimens: Collaborations with other targeted agents, immunotherapies, or novel modalities can create new revenue streams.
• Personalized Medicine Initiatives: Companion diagnostics enhancing patient selection could improve response rates, solidifying binimetinib’s position.
• Market Diversification: Entry into emerging markets with tailored pricing can boost sales.

Conclusions

Binimetinib's current market trajectory remains modest but holds potential for accelerated growth through strategic clinical and commercial initiatives. The continual evolution of oncology treatment paradigms favors targeted kinase inhibitors, especially as combination therapies become standard. Navigating competitive pressures and regulatory landscapes will be vital in maximizing its financial impact in the coming decade.

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Key Takeaways

• Binimetinib’s market is driven by increasing incidence of BRAF-mutant melanoma and growing acceptance of targeted combination therapies.
• Competition from established combinations like dabrafenib/trametinib limits near-term growth but clinical trial results and label extensions may alter this landscape.
• Revenue forecasts project incremental growth to approximately $400 million annually by mid-decade, contingent on market expansion and clinical success.
• Strategic moves include expanding indications, optimizing combination regimens, and entering emerging markets to sustain growth.
• Challenges such as high competition, safety concerns, and regulatory hurdles necessitate proactive risk management and innovation.

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FAQs

1. What is the primary indication for binimetinib?
Binimetinib is primarily approved for advanced or metastatic melanoma with BRAF V600 mutations, used in combination with encorafenib.

2. How does binimetinib compare to other BRAF-MEK inhibitors?
While similar in mechanism to dabrafenib/trametinib and encorafenib/binimetinib, binimetinib’s clinical positioning depends on specific patient population responses, side effect profiles, and regimen preferences.

3. What are the main factors affecting binimetinib’s market growth?
Market growth hinges on clinical efficacy, safety profile, competition intensity, regulatory approvals for new indications, reimbursement policies, and geographic expansion.

4. Are there prospects for binimetinib beyond melanoma?
Clinical trials are exploring its use in other cancers like colorectal and ovarian cancers, which could broaden its therapeutic scope if successful.

5. What are the key risks to binimetinib’s financial outlook?
Key risks include patent cliffs, competitive displacement, adverse safety profiles, regulatory delays, and limited clinical benefit in broader populations.

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Sources
[1] U.S. Food and Drug Administration, Mektovi (binimetinib) Prescribing Information.
[2] American Cancer Society, Cancer Facts & Figures 2022.
[3] IQVIA, Oncology Market Insights 2021.
[4] Evaluate Pharma, World Oncology Report 2022.