binimetinib - Profile

What are the generic drug 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.

There are two tentative approvals for this compound.

Summary for binimetinib

International Patents:	231
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for binimetinib

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.

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.

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

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
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
Dominican Republic	P2011000109	UN COMPUESTO SELECCIONADO DEL ACIDO 6-(-4-BROMO-2-CLORO-FENILAMINO)-7-FLUORO-3-METIL-3H-BENZOIMIDAZOL-5- CARBOXILICO (2-HIDROXI-ETOXI)- AMIDA Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO, Y COMPOSICIONES FARMACEUTICAS QUE CONTIENEN DICHO COMPUESTO
Japan	6045519
Portugal	2275102
Argentina	099630	PREPARACIÓN DE UN INHIBIDOR DE MEK Y FORMULACIÓN QUE LO COMPRENDE
China	1652776	N3 alkylated benzimidazole derivatives as MEK inhibitors
Cyprus	1109727

Supplementary Protection Certificates for binimetinib

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
1482932	648	Finland
2727918	C20190009	Finland		TZ1Y, PARTY DATA CHANGE RELATED TO A GRANTED SPC
1482932	CA 2019 00011	Denmark		PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924
1482932	LUC00100	Luxembourg		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
1482932	PA2019007,C1482932	Lithuania		PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920

Investment Scenario, Market Dynamics, and Financial Trajectory for Binimetinib

Last updated: February 3, 2026

Summary

Binimetinib is a targeted oncology drug developed by Array BioPharma (acquired by Pfizer in 2019) and marketed mainly for treating BRAF-mutated melanoma. The drug has garnered regulatory approvals, including accelerated approval by the US FDA in 2018, underscoring its significance in personalized cancer therapy. This analysis evaluates the current market landscape, competitive positioning, projected financial trajectory, and key investment considerations for binimetinib, integrating market size estimations, pipeline developments, and regulatory factors.

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What Is the Current Market Position of Binimetinib?

Approved Indications and Market Penetration

Indication	Regulatory Status	Market Share (2023)	Key Competitors
BRAF-mutated melanoma	FDA approval (2018), EMA approval	Estimated 20-25% of melanoma markets	Dabrafenib + Trametinib (Novartis)
Other solid tumors	Under clinical evaluation or off-label use	Limited; early-stage research	MEK and BRAF inhibitors (e.g., Encorafenib)

The drug’s primary commercial success is tied to its indication for advanced melanoma with BRAF V600E/K mutations. Pfizer’s strategic marketing and the drug’s inclusion in treatment guidelines have fostered steady adoption.

Market Size and Revenue Generation

Based on data from IQVIA and industry reports:

Parameter	2023 Estimate	Source/Notes
Global melanoma incident cases	~324,635 (WHO, 2021 estimate)
BRAF mutation prevalence in melanoma	40-50%	Published studies [1]
Market penetration of binimetinib	20-25% of BRAF-mutant cases	Industry estimates
Average annual treatment cost	~$20,000 - $30,000 per patient	Pharma pricing data
Estimated annual revenue (2023)	~$200M - $300M	Assumed market share & pricing

Market Dynamics and Growth Drivers

• Expansion into Additional Cancers: Ongoing trials evaluate binimetinib in other tumor types, such as ovarian and colorectal cancers.
• Combination Therapies: The combination with BRAF inhibitors (e.g., encorafenib + binimetinib) enhances efficacy, promising to broaden usage.
• Regulatory Progress: Potential approvals in indications beyond melanoma are crucial for revenue growth.
• Patient Population Growth: Increased awareness and diagnostics lead to higher incidence detection.

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How Are Market Dynamics Evolving for Binimetinib?

Competitive Landscape Analysis

Drug	Mechanism	Regulatory Status	Market Share	Notes
Dabrafenib + Trametinib	BRAF + MEK inhibitor combo	Approved (Novartis)	60-70% in BRAF melanoma	Dominant standard; patent expiry approaches
Encorafenib + Binimetinib	BRAF + MEK inhibitor combo	Approved (Pfizer)	Growing (~20%)	Approved 2018, gaining replicative share
Other MEK inhibitors	MEK inhibition	Regulatory approval	Niche, off-label	Limited adoption due to efficacy and safety concerns

Key Market Drivers

• Personalized Oncology: Increasing reliance on molecular diagnostics enhances targeted therapy adoption.
• Cost and Access Trends: Pricing strategies and healthcare coverage influence the uptake of binimetinib.
• Pipeline and Research: Positive clinical trial results can lead to expanded indications, influencing market share.

Market Challenges and Risks

• Patent Cliffs: Potential generic or biosimilar entry post-peak patent expiry.
• Adverse Events: Safety profiles influence market adoption rates.
• Pricing Pressures: Payer scrutiny may restrict reimbursement levels.

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What Financial Trajectory Is Expected for Binimetinib?

Revenue Forecasts (2023-2028)

Assumptions:

• Steady growth in BRAF-mutated melanoma cases.
• Market share stabilization at 20-25%.
• Minimal disruption from generic competition within forecast period.

Year	Estimated Revenue (USD million)	Comments
2023	$200 - $300	Baseline; current market penetration
2024	$220 - $330	Slight market expansion, pipeline updates
2025	$250 - $350	Increased approval for other indications
2026	$275 - $375	Potential new combinations or indications
2027	$300 - $400	Market maturation
2028	$320 - $430	Possible patent or exclusivity extensions

Cost and Margin Considerations

• Manufacturing Cost: Estimated at 15-20% of revenue based on drug complexity.
• Pricing Trends: Anticipated slight downward pressure due to negotiations and biosimilar threats.
• Profitability: Pfizer's margins likely to remain robust owing to existing production efficiencies and brand recognition.

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How Will Regulatory and Policy Changes Impact Binimetinib?

Policy/Regulation	Impact on Binimetinib	Notes
Patent protections & exclusivity	Ensures revenue for 8-12 years post-launch	Key driver for investment returns
Pricing policies (e.g., price caps)	Could reduce margins in certain markets	Variability across jurisdictions
Accelerated approval pathways	Facilitate faster access for indications	Ongoing clinical trials supporting expansion
Reimbursement frameworks	Influence access; positive coverage expands market	Significant in US and Europe

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Comparison with Competitors and Industry Benchmarks

Parameter	Binimetinib	Dabrafenib + Trametinib	Encorafenib + Binimetinib
Market Share (2023)	20-25%	60-70%	20%
Approved Indications	Melanoma, ongoing trials in others	Melanoma	Melanoma
Revenue (USD million)	$200 - $300	$1 billion+	Growing
Patent Status	Active until late 2020s / early 2030s	Patents expiring around 2025-2027	Patents until late 2020s
Cost of Therapy (annual)	$20,000 - $30,000	$30,000 - $50,000	Similar to binimetinib

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Key Investment Considerations

• Growth Potential: Expansion into new indications and pipeline trials can uplift revenue streams.
• Competitive Positioning: The dominance of combination therapies suggests binimetinib's reliance on partnership strategies.
• Patent Cliffs & Biosimilars: Patent expiry timelines are critical for valuation and risk assessment.
• Regulatory Pipeline: Positive trial outcomes could expand market share effectively.
• Pricing and Reimbursement: Negotiations with healthcare systems influence profitability.

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Key Takeaways

• Binimetinib maintains a solid position within the BRAF-mutated melanoma market, with stable revenues projected over the next five years.
• Market expansion hinges on its application in other cancers and successful combination therapies.
• Patent and regulatory timelines significantly influence long-term revenue prospects; Pfizer’s strategic management of IP is vital.
• Competitive dynamics favor combination regimens from larger biotech firms; binimetinib's success depends on innovative positioning and clinical trial progress.
• The evolving landscape of healthcare reimbursement policies and biosimilar entry could pose risks but also offer opportunities for strategic pricing.

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Frequently Asked Questions (FAQs)

1. What are the main factors influencing binimetinib’s market growth?
Market growth depends on expanding indications, pipeline progress, clinical trial success, regulatory approvals, and competitive positioning with combination therapies.

2. How does binimetinib compare financially to its primary competitors?
While binimetinib generates hundreds of millions annually, combination regimens like dabrafenib + trametinib surpass it, owing to broader approval and higher market share. However, binimetinib remains vital for niche indications and combination strategies.

3. When is patent expiry likely to impact binimetinib’s revenues?
Pfizer’s patents are expected to expire between late 2020s and early 2030s, after which biosimilar competition may reduce profits unless new indications or formulations are developed.

4. What is the potential for binimetinib in non-melanoma cancers?
Clinical trials are ongoing for indications such as ovarian and colon cancers, which could diversify revenue streams if trials demonstrate efficacy and gain regulatory approval.

5. How will healthcare policies affect binimetinib’s pricing and reimbursement?
Pricing pressures from payers, especially in countries with strict cost controls, could limit profit margins. Conversely, favorable reimbursement policies can expand market access.

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References

[1] WHO. "Cancer Incidence in Five Continents," 2021.

[2] IQVIA. "Global Oncology Market Report," 2022.

[3] FDA. "Binimetinib Approval Package," 2018.

[4] Pfizer, 2023. "Financial Reports and Pipeline Publications," 2023.

[5] Market Research Future. "Oncology Drugs Market Analysis," 2023.

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