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Last Updated: December 21, 2024

ERIBULIN MESYLATE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Eribulin Mesylate

A generic version of ERIBULIN MESYLATE was approved as eribulin mesylate by GLAND PHARMA LTD on April 5th, 2024.

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Drug patent expirations by year for ERIBULIN MESYLATE
Recent Clinical Trials for ERIBULIN MESYLATE

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SponsorPhase
Australia New Zealand Gynaecological Oncology GroupPhase 2
Merck Sharp & Dohme LLCPhase 2
M.D. Anderson Cancer CenterPhase 1/Phase 2

See all ERIBULIN MESYLATE clinical trials

Pharmacology for ERIBULIN MESYLATE
Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition
Paragraph IV (Patent) Challenges for ERIBULIN MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
HALAVEN Injection eribulin mesylate 1 mg/2 mL 201532 1 2019-12-20

US Patents and Regulatory Information for ERIBULIN MESYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp ERIBULIN MESYLATE eribulin mesylate SOLUTION;INTRAVENOUS 217250-001 Oct 1, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Long Grove Pharms ERIBULIN MESYLATE eribulin mesylate SOLUTION;INTRAVENOUS 214850-001 Jul 18, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd ERIBULIN MESYLATE eribulin mesylate SOLUTION;INTRAVENOUS 218047-001 Apr 5, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Jiangxi Qingfeng ERIBULIN MESYLATE eribulin mesylate SOLUTION;INTRAVENOUS 218281-001 Jun 28, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ERIBULIN MESYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Eribulin Mesylate

Introduction

Eribulin mesylate, marketed under the brand name Halaven, is a nontaxane microtubule dynamics inhibitor belonging to the halichondrin class of drugs. It is primarily used in the treatment of metastatic breast cancer and has shown promising results in various clinical trials. Here, we delve into the market dynamics and financial trajectory of eribulin mesylate.

Market Growth and Forecast

The pharmaceutical grade eribulin mesylate market has experienced rapid and substantial growth in recent years. Forecasts indicate that this expansion will continue from 2023 to 2031, driven by positive market dynamics and sustained growth rates[1].

Market Size and Segmentation

The market size of pharmaceutical grade eribulin mesylate is segmented based on type (purity ≥99% and purity <99%) and application (solution and others), as well as geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation provides a comprehensive analysis of the market's various facets[1].

Geographical Performance

The Asia-Pacific region is expected to be a significant contributor to the market growth due to increasing healthcare expenditures and a rising demand for advanced cancer treatments. North America and Europe also play crucial roles, driven by advanced healthcare infrastructure and higher adoption rates of innovative therapies[1].

Key Drivers and Restraints

Drivers

  • Increasing Incidence of Breast Cancer: The rising incidence of breast cancer globally is a major driver for the eribulin mesylate market. As more patients seek effective treatments, the demand for eribulin mesylate is expected to increase.
  • Efficacy and Safety Profile: Clinical trials have demonstrated that eribulin mesylate has a comparable efficacy to traditional chemotherapy options and a manageable safety profile, which enhances its market appeal[4][5].

Restraints

  • High Cost: Eribulin mesylate is a costly treatment, which can limit its accessibility in some regions, particularly in developing countries.
  • Side Effects: While the safety profile is manageable, common adverse events such as asthenia or fatigue, neutropenia, alopecia, and peripheral neuropathy can affect patient compliance and market growth[4].

Financial Performance and Projections

Revenue Forecast

The market for pharmaceutical grade eribulin mesylate is projected to see significant revenue growth from 2023 to 2031. The report forecasts that the market will continue its upward trend, driven by increasing demand and expanding geographical reach[1].

Key Players and Market Share

Companies such as Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, Dr Reddys Laboratories Ltd, and others are key players in the eribulin mesylate market. These companies are investing heavily in research and development to improve the purity and efficacy of eribulin mesylate, which is expected to drive market growth[1].

Clinical Efficacy and Outcomes

Comparative Efficacy

Eribulin mesylate has demonstrated comparable efficacy to traditional chemotherapy options in patients with HER2-low or HER2-0 metastatic breast cancer. Studies have shown trends toward improved outcomes in terms of overall survival (OS) and progression-free survival (PFS) when compared to other chemotherapeutic controls[5].

Quality of Life and Safety

Clinical trials have indicated that eribulin mesylate maintains a high quality of life for patients, with global health status and overall quality-of-life scores similar to those of other treatments. The safety profile, while manageable, includes common adverse events that are clinically acceptable[4].

Market Opportunities and Challenges

Opportunities

  • Expanding Indications: There is potential for eribulin mesylate to be approved for additional indications beyond metastatic breast cancer, which could expand its market.
  • Emerging Markets: Growing healthcare infrastructure in emerging markets presents opportunities for increased market penetration.

Challenges

  • Regulatory Hurdles: Strict regulatory requirements and the need for continuous clinical trials to maintain approval can be challenging.
  • Competition: The market for breast cancer treatments is highly competitive, with various other drugs and therapies available, which can impact market share[1].

Pricing and Penetration

Pricing Analysis

The pricing of eribulin mesylate is a critical factor influencing its market dynamics. High pricing can limit accessibility, while competitive pricing can enhance market penetration. The report includes a detailed pricing analysis to understand the impact on market outcomes[1].

Product Penetration

The extent of product penetration at national and regional levels is crucial. Factors such as national GDP, market dynamics, and consumer behavior influence the penetration of eribulin mesylate in different regions[1].

Competitive Landscape

The eribulin mesylate market is characterized by a mix of established and emerging players. Companies like Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, and Dr Reddys Laboratories Ltd are prominent in the market. The report provides detailed profiles of these companies, including their market entry year and various market-related factors[1].

Porter's 5 Forces Framework

Threat of New Entrants

The threat of new entrants is moderate due to the high barriers to entry, including stringent regulatory requirements and significant research and development costs.

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low as there are multiple suppliers for the raw materials needed to produce eribulin mesylate.

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and the cost of the drug.

Threat of Substitute Products

The threat of substitute products is high due to the presence of other chemotherapy options and emerging therapies.

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of multiple players and the need to differentiate products through innovation and pricing strategies[1].

Conclusion

The market for eribulin mesylate is poised for significant growth driven by its efficacy, manageable safety profile, and expanding geographical reach. However, it faces challenges such as high costs, regulatory hurdles, and competition from other treatments.

Key Takeaways

  • Rapid Market Growth: The eribulin mesylate market is expected to grow substantially from 2023 to 2031.
  • Clinical Efficacy: Eribulin mesylate has demonstrated comparable efficacy to traditional chemotherapy options.
  • Safety Profile: The drug has a manageable safety profile with common adverse events.
  • Market Segmentation: The market is segmented by type, application, and geographical regions.
  • Key Players: Companies like Natco Pharma Ltd and Emcure Pharmaceuticals Ltd are key players in the market.

FAQs

What is eribulin mesylate used for?

Eribulin mesylate is primarily used in the treatment of metastatic breast cancer, particularly in patients with HER2-low or HER2-0 disease.

What are the common side effects of eribulin mesylate?

Common side effects include asthenia or fatigue, neutropenia, alopecia, and peripheral neuropathy.

How does eribulin mesylate compare to traditional chemotherapy?

Eribulin mesylate has demonstrated a trend toward improved outcomes in terms of overall survival and progression-free survival compared to traditional chemotherapy options.

What are the key drivers of the eribulin mesylate market?

Key drivers include the increasing incidence of breast cancer, the drug's efficacy and safety profile, and expanding geographical reach.

Who are the major players in the eribulin mesylate market?

Major players include Natco Pharma Ltd, Emcure Pharmaceuticals Ltd, Dr Reddys Laboratories Ltd, and others.

Sources

  1. Market Research Intellect, "Global Pharmaceutical Grade Eribulin Mesylate Market Size, Trends, and Forecast 2023-2031."
  2. OncologyPRO, "Real-world activity of sacituzumab govitecan for metastatic breast cancer."
  3. Market Research Intellect, "Ureter Cancer Drugs Market Size And Forecast."
  4. Journal of Clinical Oncology, "Phase III Open-Label Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer."
  5. OncLive, "Eribulin Demonstrates Comparable Efficacy to Traditional Chemotherapy Options in HER2-Low and HER2-0 Metastatic Breast Cancer."

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