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Last Updated: March 25, 2025

Binimetinib - Generic Drug Details


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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.

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

Summary for binimetinib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for binimetinib
Generic Entry Date for binimetinib*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Merck Sharpe & Dohme LLCPhase 2
National Cancer Center, JapanPhase 2
Taiho Oncology, Inc.Phase 3

See all binimetinib clinical trials

Generic filers with tentative approvals for BINIMETINIB
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free15MGTABLET
⤷  Try for Free⤷  Try for Free15MGTABLET;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 15 mg 210498 3 2022-06-27

US Patents and Regulatory Information for binimetinib

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y Y ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for binimetinib

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Try for Free ⤷  Try for Free
Array Biopharma Inc MEKTOVI binimetinib TABLET;ORAL 210498-001 Jun 27, 2018 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

EU/EMA Drug Approvals for binimetinib

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Pierre Fabre Medicament Mektovi binimetinib EMEA/H/C/004579
Binimetinib 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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 1 of 1 entries

International Patents for binimetinib

CountryPatent NumberTitleEstimated Expiration
Argentina 045738 DERIVADOS DE BENCIMIDAZOL N3 ALQUILADOS COMO INHIBIDORES DE MEK ⤷  Try for Free
European Patent Office 2909182 PRÉPARATION D'UN INHIBITEUR DE MEK ET FORMULATION LE CONTENANT (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR) ⤷  Try for Free
Hong Kong 1167390 ⤷  Try for Free
Poland 230179 ⤷  Try for Free
South Africa 200407220 N3 alkylated benzimidazole derivatives as MEK inhibitors ⤷  Try for Free
South Korea 101413392 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for binimetinib

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1482932 C 2019 008 Romania ⤷  Try for Free PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
1482932 C01482932/01 Switzerland ⤷  Try for Free PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019
1482932 C201930018 Spain ⤷  Try for Free PRODUCT NAME: BINIMETINIB O UNA SAL O UN SOLVATO FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920
2470526 CA 2019 00012 Denmark ⤷  Try for Free PRODUCT NAME: ENCORAFENIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1314 20180924
1482932 SPC/GB19/007 United Kingdom ⤷  Try for Free PRODUCT NAME: BINIMETINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/18/1315/001-002 20180920
2470526 SPC/GB19/009 United Kingdom ⤷  Try for Free PRODUCT NAME: ENCORAFENIB OR PHARMACEUTICALLY ACCEPTABLE SALTS OR SOLVATES THEREOF; REGISTERED: UK EU/1/18/1314/001-002 20180924; UK PLGB 00603/0240-0001 20180924; UK PLGB 00603/0241-0001 20180924
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

Market Dynamics and Financial Trajectory for Binimetinib

Market Overview

Binimetinib, a MEK inhibitor, is a targeted treatment primarily used for advanced melanoma and other cancers. The market for binimetinib is poised for significant growth, driven by several key factors.

Growth Drivers

  • Increasing Incidence of Cancer: The rising incidence of melanoma and solid tumors globally is a major driver for the demand of targeted therapies like binimetinib[1].
  • Advances in Precision Medicine: The tailoring of treatments based on tumor genetics has increased the use of binimetinib, as it targets specific cellular pathways, making it more efficient and tolerable for patients[1].
  • Therapeutic Efficacy and Side Effects: Patients prefer binimetinib due to its therapeutic efficacy and manageable side effects, contributing to its growing demand[1].
  • Ongoing Research and Development: Continuous research and development efforts are expanding the applications of binimetinib, further boosting its market growth[1].

Regional Market Dynamics

  • North America: This region currently dominates the binimetinib market, with a significant share driven by advanced healthcare infrastructure and high adoption rates of targeted therapies[1].
  • Europe: Europe is the second-largest region, with substantial demand fueled by rising cancer incidence, supportive government initiatives, and a well-established pharmaceutical industry[1].
  • Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, driven by a large and expanding cancer population, particularly in China and India, along with increasing healthcare expenditure and infrastructure[1].

Key Market Players

The binimetinib market is dominated by a few major companies:

  • Pfizer: Following its acquisition of Array BioPharma in 2019 for $11.4 billion, Pfizer has become a key player in the market. Pfizer's financial reports indicate significant investments in oncology products, including binimetinib[5].
  • Alembic Pharma: Another major player, Alembic Pharma is involved in the production and commercialization of binimetinib, particularly in the API market[4].
  • Other Players: Companies like MSN Laboratories, Hetero Drugs, and BOC Sciences also play crucial roles in the binimetinib API market[4].

Financial Trajectory

Revenue and Growth

  • The binimetinib market is projected to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2034, reaching a significant market value by the end of the forecast period[1].
  • The market was valued at USD XX Million in 2024 and is expected to increase substantially over the next decade[1].

Pricing Trends and Average Selling Prices

  • The pricing of binimetinib is influenced by various factors, including production costs, regulatory approvals, and market competition. The average selling prices (ASPs) are expected to stabilize as the market matures and more players enter the scene[1].

Recent Financial Highlights

  • Pfizer's financial reports show that while the company experienced a decline in revenues from COVID-19 related products, there was a 5% operational growth in revenues excluding contributions from Comirnaty and Paxlovid. This growth was partly driven by recently acquired products, including those in the oncology segment[2].

Development and Commercialization Costs

  • The development and commercialization of binimetinib involve significant costs. Array BioPharma and Pierre Fabre have agreed to split these costs on a 60:40 basis, with initial funding committed for new clinical trials in colorectal cancer and melanoma[3].

Impact of Collaborations and Acquisitions

  • The collaboration between Array BioPharma and Pierre Fabre has been instrumental in the global development and commercialization of binimetinib. Array retains exclusive commercialization rights in the U.S., Canada, Japan, Korea, and Israel, while Pierre Fabre has rights in other countries[3].
  • Pfizer's acquisition of Array BioPharma has further strengthened its position in the oncology market, providing the financial and operational resources to drive the growth of binimetinib[5].

Regulatory Approvals and Clinical Trials

  • Regulatory approvals play a crucial role in the market growth of binimetinib. For instance, the U.S. FDA's acceptance of supplemental New Drug Applications (sNDAs) for Braftovi (encorafenib) and Mektovi (binimetinib) in April 2023 is a significant milestone[2].
  • Ongoing and planned clinical trials, such as the Phase 3 trials for melanoma and ovarian cancer, are critical for expanding the therapeutic applications of binimetinib[3].

Market Challenges and Limitations

  • Despite the growth drivers, the binimetinib market faces challenges such as high development costs, regulatory hurdles, and competition from other targeted therapies[1].
  • The market is also subject to the risks associated with clinical trial outcomes and the ability of companies to meet development and commercialization milestones[3].

Key Takeaways

  • The binimetinib market is driven by increasing cancer incidence, advances in precision medicine, and ongoing research.
  • North America and Europe are significant markets, with the Asia Pacific region expected to grow rapidly.
  • Pfizer and Alembic Pharma are key players, with other companies contributing to the API market.
  • The market is expected to grow at a significant CAGR, with substantial revenue growth projected.
  • Collaborations and acquisitions, such as Pfizer's acquisition of Array BioPharma, are crucial for market growth.

FAQs

What is binimetinib used for?

Binimetinib is primarily used to treat advanced melanoma and certain other cancers by inhibiting the MEK protein, which prevents the growth and spread of cancer cells.

Which companies are major players in the binimetinib market?

The major players include Pfizer, Alembic Pharma, MSN Laboratories, Hetero Drugs, and BOC Sciences.

What are the key drivers of the binimetinib market?

The key drivers include the increasing incidence of cancer, advances in precision medicine, therapeutic efficacy, and ongoing research and development.

How is the Asia Pacific region contributing to the binimetinib market?

The Asia Pacific region is expected to be the fastest-growing segment due to a large and expanding cancer population, increasing healthcare expenditure, and improving healthcare infrastructure.

What is the impact of regulatory approvals on the binimetinib market?

Regulatory approvals, such as those from the U.S. FDA, are crucial for the market growth of binimetinib, as they validate the safety and efficacy of the drug and allow for broader commercialization.

Sources

  1. We Market Research - Binimetinib Market Research Report 2024-2034
  2. Pfizer - Pfizer Reports First-Quarter 2023 Results
  3. PR Newswire - Array BioPharma And Pierre Fabre Announce Development And Commercialization Collaboration For Two Novel Oncology Products
  4. Valuates Reports - Global Binimetinib API Market Insights, Forecast to 2029
  5. Pfizer - Pfizer to Acquire Array BioPharma

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