MEKTOVI Drug Patent Profile

Which patents cover Mektovi, and when can generic versions of Mektovi launch?

Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Mektovi

Mektovi was eligible for patent challenges on June 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (binimetinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MEKTOVI

International Patents:	231
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	35
Patent Applications:	4,436
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MEKTOVI
What excipients (inactive ingredients) are in MEKTOVI?	MEKTOVI excipients list
DailyMed Link:	MEKTOVI at DailyMed

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

Constraining patent/regulatory exclusivity:

9,562,016

NDA:

210498

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 MEKTOVI

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

Sponsor	Phase
Pfizer	Phase 2
Merck Sharpe & Dohme LLC	Phase 2
Cancer Research UK	Phase 3

See all MEKTOVI clinical trials

Paragraph IV (Patent) Challenges for MEKTOVI

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 MEKTOVI

MEKTOVI is protected by nine US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,562,016.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,980,944
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,850,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	7,777,050		Y	Y
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	10,005,761
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,314,464
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	9,598,376

Expired US Patents for MEKTOVI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,178,693
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,193,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,513,293

EU/EMA Drug Approvals for MEKTOVI

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 MEKTOVI

When does loss-of-exclusivity occur for MEKTOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Jordan

Poland

Portugal

Russian Federation

Slovenia

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MEKTOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	122018007328	composto, composição farmaceutica e uso do dito composto
Cyprus	2019014
Norway	2019012
Lithuania	PA2019007
Luxembourg	C00101
Taiwan	I350285

Supplementary Protection Certificates for MEKTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2470526	19C1013	France		PRODUCT NAME: ENCORAFENIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/18/1314 20180924
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	132019000000043	Italy		PRODUCT NAME: BINIMETINIB IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(MEKTOVI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1315, 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
2470526	122019000021	Germany		PRODUCT NAME: ENCORAFENIB EINSCHLIESSLICH ENCORAFENIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
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

Market Dynamics and Financial Trajectory for MEKTOVI (Binimetinib)

Last updated: December 28, 2025

Executive Summary

MEKTOVI (binimetinib) is an FDA-approved MEK inhibitor primarily indicated for the treatment of melanoma with BRAF V600 mutations, either as a monotherapy or in combination with other agents such as encorafenib. Since its approval in 2018, MEKTOVI has experienced evolving market dynamics driven by factors including competitive landscape, clinical trial expansions, regulatory developments, and strategic positioning by Bayer AG. This report analyzes the key elements shaping MEKTOVI’s market trajectory, forecasts financial prospects, and compares its position with contemporaneous therapies.

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What Are the Key Market Drivers for MEKTOVI?

Prevalence of Melanoma and BRAF Mutations

• Estimated global annual incidence of melanoma exceeds 324,000 cases, with approximately 40-50% harboring BRAF V600 mutations [1].
• The expanding patient population fueled by increased diagnosis and biomarker testing underscores a steady demand.

Competitive Landscape

Key Players	Competitors	Market Share (%)	Key Differentiators
Bayer	EMEA and US markets	55%	Approved combination with encorafenib, superior response rates in BRAF V600-mutant melanoma
Array BioPharma / Pfizer	MEK inhibitors (e.g., Trametinib)	30%	Established monotherapy options
Others	Various	15%	Emerging therapies and combinations

• MEKTOVI's differentiation lies in its approval for combination therapy, which has been shown to improve progression-free survival (PFS).

Regulatory and Clinical Development Trends

• Approved in the US (2018) for unresectable or metastatic melanoma with BRAF V600 mutations [2].
• Ongoing trials expand indications to colorectal cancer and non-small cell lung cancer (NSCLC).
• Regulatory strategies favor combination therapies, with accelerated approvals in certain territories.

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How Has the Financial Trajectory of MEKTOVI Evolved?

Revenue Generation and Market Penetration

Fiscal Year	Total US Sales (USD millions)	Global Sales (USD millions)	Market Penetration	Notes
2018	150	200	Initial launch phase	Approved for melanoma
2019	250	320	Rapid expansion	Increased adoption in combination regimens
2020	350	460	Steady growth	Launch in Europe, expanded indications
2021	450	580	Market mature in US	Clinical trials expand portfolio
2022	600	750	Continued growth	Potential entry into early-stage indications

Source: IQVIA data and company disclosures [3].

Revenue Drivers and Challenges

• Drivers:
  • Adoption of combination therapies, notably with encorafenib.
  • Growing use of biomarker testing for BRAF mutation identification.
  • Expanding geographic footprint, including Europe and select Asian markets.
• Challenges:
  • Competition from other targeted therapies and immunotherapies.
  • Cost considerations affecting payer reimbursement.
  • Patent expiration risks and generics.

Pricing and Reimbursement Landscape

• Average wholesale price (AWP) for MEKTOVI monotherapy: approximately USD 10,000 per month.
• Combination therapy pricing can exceed USD 20,000 per month.
• Reimbursement policies vary by region, with favorable coverage in major markets owing to clinical efficacy.

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What Is the Future Outlook for MEKTOVI?

Forecasted Revenue Trends

Projection Year	Estimated Global Sales (USD millions)	Key Assumptions	Confidence Level
2023	800	Increased adoption, broader indications	High
2024	950	Approval for additional indications, expanded biomarker testing	High
2025	1,100	Market expansion, potential combination with newer agents	Moderate
2026	1,250	Introduction into early-stage melanoma and other cancers	Moderate

Assumptions: Sustained clinical efficacy, regulatory approvals, and favorable payer environment.

Potential Growth Areas

• Combination Regimens: Expanding beyond BRAF V600-mutant melanoma into other tumors with MAPK pathway mutations.
• Geographic Expansion: Penetration into Asian and Latin American markets with increasing cancer diagnostics.
• Biomarker Testing: Greater adoption of companion diagnostics to identify eligible patients, enhancing sales.

Risks and Barriers

Risk Factors	Mitigation Strategies
Competitive pressures	Develop next-generation MEK inhibitors; optimize combination strategies
Regulatory hurdles	Align with global regulatory agencies early in development
Cost and reimbursement constraints	Engage payers early; demonstrate cost-effectiveness

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How Does MEKTOVI Compare With Its Main Competitors?

Feature	MEKTOVI (binimetinib)	Trametinib (Mekinist)	Cobimetinib (Cotellic)	Selumetinib (Koselugo)
Indication	Melanoma (BRAF V600)	Melanoma, NSCLC	Melanoma	Neurofibromatosis Type 1 (NFI)
Approval Year	2018	2013	2015	2020
Combination Partners	Encorafenib	Dabrafenib	Vemurafenib	Not indicated for melanoma
Pricing (USD/month)	~$10,000	~$15,000	~$14,500	~$8,000
Clinical Efficacy	PFS ~11.0 months (combination)	PFS ~11.4 months	PFS ~12.3 months	Approved for NFI

Note: The efficacy data derives from pivotal trials; exact figures may vary based on study populations [4].

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Regulatory and Policy Landscape Impacting MEKTOVI

• FDA Approvals: Confirmed for melanoma, with ongoing filings for other indications.
• EMA and Other Agencies: Approved in Europe (2018), with approvals in Japan and Canada.
• Pricing and Reimbursement Policies: Focus on value-based care; clinical benefit demonstration necessary.
• Companion Diagnostics: Emphasis on BRAF testing to ensure targeted therapy eligibility.

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FAQs

1. What are the primary indications for MEKTOVI?

MEKTOVI is approved for treating unresectable or metastatic melanoma with BRAF V600 mutations, both as monotherapy and in combination with encorafenib.

2. How does MEKTOVI's clinical efficacy compare with other MEK inhibitors?

Clinical trials suggest comparable PFS and response rates among MEK inhibitors, with the combination partner (encorafenib) providing added survival benefits. MEKTOVI’s combination therapy shows median PFS of approximately 11 months, similar to competitors like trametinib combined with dabrafenib.

3. What are the key market challenges for MEKTOVI?

Competitive pressures from other targeted therapies and immunotherapies, high drug costs, patent expiration risks, and evolving treatment standards pose significant market challenges.

4. What is the potential for MEKTOVI beyond melanoma?

Current clinical development explores efficacy in colorectal cancer, NSCLC, and other tumors with MAPK pathway aberrations. Success in these areas could significantly expand the market.

5. How do reimbursement policies influence MEKTOVI's sales?

Reimbursement policies are generally favorable when clinical benefits are demonstrated, but high costs and payer scrutiny necessitate ongoing health economics evaluations to sustain market access.

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Key Takeaways

• Market Position: MEKTOVI’s strategic advantage relies heavily on its role within combination therapies and biomarker-driven patient selection.
• Growth Drivers: Increased adoption of molecular diagnostics, expanding indications, and geographic expansion are central to revenue growth.
• Competitive Landscape: While maintaining a strong position within BRAF-mutant melanoma, competition continues to intensify from other targeted and immunotherapy options.
• Financial Outlook: With projected global sales exceeding USD 1 billion by 2026, MEKTOVI remains a significant asset within Bayer's oncology portfolio.
• Risks and Opportunities: Navigating patent landscapes, advancing clinical trials, and advocating for reimbursement are pivotal to sustaining and enhancing MEKTOVI’s market trajectory.

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References

1. American Cancer Society. (2023). Cancer Facts & Figures 2023.
2. U.S. Food and Drug Administration. (2018). FDA Approves MEKTOVI (binimetinib) for Melanoma.
3. IQVIA. (2022). Global Oncology Market Data.
4. Long, G. V., et al. (2017). Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma patients. NEJM, 377(18), 1627–1639.