MEKTOVI Drug Patent Profile

Which patents cover Mektovi, and what generic alternatives are available?

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

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
Accord Healthcare, Inc.	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 one FDA Regulatory Exclusivity.

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
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 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
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 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
South Africa	200407220	N3 alkylated benzimidazole derivatives as MEK inhibitors
European Patent Office	2275102	Dérivés de benzimidazole d'alkylat N3 en tant qu'inhibiteurs de Mek (N3 alkylated benzimidazole derivatives as MEK inhibitors)
Guatemala	201200053	COMPUESTOS Y COMPOSICIONES COMO INHIBIDORES DE CINASA DE PROTEÍNA

Supplementary Protection Certificates for MEKTOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	1990010-9	Sweden		PRODUCT NAME: BINIMETINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS AND SOLVATES THEROF; REG. NO/DATE: EU/1/18/1315 20180924
1482932	2019C/510	Belgium		PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924
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

Market Dynamics and Financial Trajectory for MEKTOVI (binimetinib and encorafenib)

Last updated: March 31, 2026

What is MEKTOVI and its therapeutic scope?

MEKTOVI (binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor) was approved by the FDA in June 2018 for the treatment of BRAF V600E and V600K-mutant metastatic melanoma. Subsequently, it gained FDA approval in 2020 for metastatic colorectal cancer with BRAF V600E mutation in combination with encorafenib and cetuximab.

Market size and growth drivers

Melanoma segment

• The global melanoma treatment market was valued at approximately USD 2.2 billion in 2021.
• Expected compound annual growth rate (CAGR) is around 8% through 2026.
• The BRAF V600 mutation occurs in about 50% of melanoma cases, representing an initial sizeable patient pool.

Colorectal cancer segment

• The colorectal cancer market was valued at USD 13.5 billion in 2021.
• BRAF V600E mutations occur in 8-10% of colorectal cases, with targeted therapies like MEKTOVI combination expected to capture a segment of this.
• Growth driven by increased mutation testing and precision medicine adoption.

Competitive landscape

• MEKTOVI faces competition from other BRAF and MEK inhibitors, such as Zelboraf (vemurafenib), Tafinlar (dabrafenib), and Mekinist (trametinib).
• Approved for combination therapy, it leverages co-treatment strategies with other targeted agents, increasing its market share.

Revenue trajectory and financial performance

Sales overview (2022-2025 projection)

Year	Estimated global sales (USD millions)	Growth rate (%)
2022	250	—
2023	340	36
2024	450	32
2025	600	33

• Initial revenue of USD 250 million in 2022, driven by U.S. and European market penetration.
• Growth fueled by increased off-label use, expanded indications, and greater adoption of mutation testing.

Financial drivers

1. Prescription volume growth: Expanding physician awareness and testing protocols.
2. Pricing strategies: Per-unit pricing remains stable but benefits from increased combination therapy use.
3. Payer coverage: Improved through evidence from ongoing trials and label expansions.
4. Pricing pressure: Potential reduction due to competition and biosimilar entry elsewhere in the pipeline.

Pipeline developments and impact on future growth

• Ongoing trials assess efficacy in other cancers, including non-small cell lung cancer, glioma, and other solid tumors.
• Positive trial data could lead to new indications, expanding the market.
• The potential for combination regimens with immune checkpoint inhibitors may reshape its role, impacting future revenue.

Regulatory and market access considerations

• US, EU, and Asia-Pacific markets approve MEKTOVI as a combination therapy.
• Price negotiations with payers vary by region, affecting net revenue.
• The cost of targeted therapy remains high, impacting patient access and reimbursement rates.

Key market risks and opportunities

Risks

• Market saturation due to competing therapies.
• Patent expirations affecting exclusivity timelines.
• Regulatory delays or restrictions on new indications.

Opportunities

• Expansion into additional cancer types.
• Biomarker-driven patient selection improving outcomes.
• Increasing adoption of genetic testing guiding personalized therapy.

Conclusion

MEKTOVI is positioned for steady growth in the targeted oncology space, with revenue projections reaching USD 600 million by 2025. The market expansion hinges on outcomes from ongoing research, clinical trial success, and healthcare system integration of mutation testing. Competitive pressure and reimbursement policies will influence its financial trajectory.

Key Takeaways

• MEKTOVI's sales are expected to grow over 30% annually through 2025, driven by increased indication approvals and mutation testing.
• The therapy addresses a sizeable segment in melanoma and colorectal cancer, with further pipeline opportunities.
• Competition and pricing pressures pose risks to revenue stability.
• Expansion into additional indications and combination regimens remains a primary growth avenue.
• Reimbursement strategies and regulatory approvals across global markets significantly influence market penetration.

FAQs

1. What is the primary indication for MEKTOVI?
   BRAF V600E/K-mutant metastatic melanoma.

2. When was MEKTOVI first approved?
   June 2018 by the FDA.

3. What is the projected revenue for MEKTOVI in 2025?
   Approximately USD 600 million.

4. What are the main competitors to MEKTOVI?
   Zelboraf (vemurafenib), Tafinlar (dabrafenib), and Mekinist (trametinib).

5. What factors could influence future growth?
   New indications, combination therapy approvals, clinical trial results, and reimbursement policies.

References

[1] Market Research Future. (2022). Melanoma Treatment Market Report.
[2] Grand View Research. (2021). Colorectal Cancer Market Size & Trends.
[3] U.S. Food and Drug Administration. (2018). FDA approves combination drug for melanoma.
[4] EvaluatePharma. (2022). Oncology drug sales forecast.