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

Constraining patent/regulatory exclusivity:

9,562,016

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
Pierre Fabre Pharma GmbH	PHASE4
SRH Wald-Klinikum Gera GmbH	PHASE4
Pierre Fabre Laboratories	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	9,980,944
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	9,850,229

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	8,193,229
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	7,777,050
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,513,293
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018	8,178,693

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
South Africa	201202020	COMPOUNDS AND COMPOSITIONS AS PROTEIN KINASE INHIBITORS
Dominican Republic	P2012000051
Brazil	PI0413152	derivados de benzimidazol alquilado por n3 como inibidores de mek
China	101633644	N3 alkylated benzimidazole derivatives as mek inhibitors

Supplementary Protection Certificates for BINIMETINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1482932	334 8-2019	Slovakia		PRODUCT NAME: BINIMETINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1315 20180924
2470526	PA2019005,C2470526	Lithuania		PRODUCT NAME: ENKORAFENIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1314 20180920
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
2727918	122019000023	Germany

Market Dynamics and Financial Trajectory for Binimetinib

Last updated: February 20, 2026

What is Binimetinib and Its Approved Indications?

Binimetinib is a MEK inhibitor developed by Array BioPharma, acquired by Pfizer in 2019. It is approved for treating advanced or metastatic melanoma with BRAF V600 mutations, specifically when combined with BRAF inhibitors like encorafenib. Its regulatory approval in the United States came in June 2018 under the brand name Mektovi [1].

Market Landscape and Competitive Position

Key Competitors

• Trametinib (Mekinist): Approved for BRAF-mutant melanoma; licensed by Novartis.
• Cobimetinib (Cotellic): Approved for melanoma; marketed by Genentech/Roche.
• Selumetinib: Under investigation for various cancers, including neurofibromatosis type 1.

Market Size and Growth Opportunities

• Estimated global melanoma market size was valued at approximately $2.2 billion in 2022.
• Expected compound annual growth rate (CAGR) for melanoma therapeutics: around 8% from 2023 to 2030 [2].
• Binimetinib's core revenue stems from its use in melanoma; additional potential for other cancers remains under clinical investigation.

Key Market Drivers

• Increasing incidence of melanoma: approximately 5.7 cases per 100,000 people globally, with higher rates in developed countries.
• Adoption of combination therapies, integrating BRAF and MEK inhibitors, enhances efficacy and extends survival.
• Expanding biomarker testing improves patient selection for targeted therapy.

Market Challenges

• Competition from established drugs such as trametinib, which has long market presence.
• Side effect profiles differ; toxicity management influences prescribing patterns.
• Licensing restrictions and patent expirations could threaten market exclusivity.

Financial Trajectory and Revenue Trends

Revenue Performance

• Pfizer reported that Binimetinib, as part of the BRAF/MEK inhibitor combinations, contributed modest revenue, approximately $50-100 million globally in 2022.
• The drug's sales are highly dependent on the adoption rate of combination regimens and regulatory approvals in new indications.

Pricing Landscape

• Approximate wholesale acquisition cost (WAC) per month in the U.S.: $15,000–$17,000.
• Price competitiveness affects market penetration, especially amidst competition from entrenched therapies.

Key Collaborations and Marketing Strategies

• Pfizer markets Binimetinib primarily through oncologist specialists and targeted marketing efforts.
• Opportunities exist for expansion into other BRAF-mutant cancers pending clinical trial success.

Research and Development Pipelines

• Multiple clinical trials evaluate Binimetinib in other tumor types, including colorectal and lung cancers.
• On ongoing trials, combinatorial efficacy with immunotherapies such as checkpoint inhibitors.

Regulatory Environment and Patent Outlook

• Patent protections for Binimetinib are expected to expire around 2030, with patents on certain formulations potentially expiring earlier.
• Regulatory approvals remain confined mostly to melanoma; expansion to other indications could generate revenue growth.

Strategic Opportunities and Risks

Opportunities

• Expanding therapeutic indications.
• Developing biosimilars or generics post-patent expiry.
• Enhancing combination therapy protocols to improve clinical outcomes.

Risks

• Competitive pressures from alternative therapies.
• Regulatory hurdles impeding approval for new indications.
• Potential side effects impacting safety profiles and prescribing behaviors.

Key Takeaways

• Binimetinib remains a targeted therapy within a growing melanoma market; its revenue contribution is modest relative to its competitors.
• The drug's future hinges on expanding indications, clinical trial outcomes, and navigating patent expiries.
• Pricing strategies and market penetration depend heavily on combination therapy adoption and reimbursement policies.

FAQs

1. Will Binimetinib's sales grow with upcoming melanoma cases?
They depend on combination therapy adoption rates and potential new indications; current growth is limited by competition and existing market dominance by drugs like trametinib.

2. Are there plans to expand Binimetinib into other cancers?
Yes; ongoing clinical trials are evaluating efficacy in colorectal and non-small cell lung cancers.

3. How does Binimetinib's side effect profile compare to competitors?
It has similar adverse events, including rash, diarrhea, and edema, influencing therapy choices based on patient tolerability.

4. What is the patent outlook for Binimetinib?
Patents are expected to last until approximately 2030; post-expiry, biosimilar or generic options may emerge.

5. How does pricing influence market penetration?
High costs necessitate insurer coverage and patient affordability; competitive pricing may enhance adoption against established alternatives.

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References

[1] U.S. Food and Drug Administration. (2018). FDA approves treatment for BRAF V600E-mutant melanoma.
[2] Grand View Research. (2022). Melanoma market size analysis and forecast.