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Last Updated: December 22, 2024

MESNA Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Mesna

A generic version of MESNA was approved as mesna by FRESENIUS KABI USA on April 26th, 2001.

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Summary for MESNA
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US Patents and Regulatory Information for MESNA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa MESNA mesna INJECTABLE;INTRAVENOUS 075811-001 Apr 26, 2001 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa MESNA mesna INJECTABLE;INTRAVENOUS 075764-001 Apr 27, 2001 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Institutional MESNA mesna INJECTABLE;INTRAVENOUS 076488-001 Mar 8, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland MESNA mesna INJECTABLE;INTRAVENOUS 206992-001 Dec 18, 2017 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma MESNA mesna INJECTABLE;INTRAVENOUS 075739-001 Jan 9, 2004 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

MESNA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Mesna

Introduction to Mesna

Mesna, also known as sodium 2-mercapto-ethane sulfonate, is a prophylactic medication used primarily to reduce the incidence of ifosfamide-induced and cyclophosphamide-induced hemorrhagic cystitis in patients undergoing chemotherapy. Its mechanism involves detoxifying the urotoxic byproduct acrolein, which is a breakdown product of these chemotherapeutic agents[5].

Market Size and Growth

The mesna market has been experiencing significant growth over the past few years and is projected to continue this trend from 2023 to 2031. Here are some key points regarding the market size and growth:

  • Global Mesna Market Size: The market is expected to grow at a moderate to substantial pace, with a Compound Annual Growth Rate (CAGR) of 3 to 5 percent during the forecast period. The estimated valuation of the mesna market is projected to reach several hundred million USD by 2031[3][4].
  • Segmentation: The market is segmented based on product type (oral and injections), application (hospital pharmacies, retail pharmacies, and online pharmacies), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[3][4].

Drivers of Market Growth

Several factors are driving the growth of the mesna market:

  • Increasing Cancer Incidence: The rising incidence of cancer and the subsequent increase in chemotherapy treatments are major drivers. Chemotherapy is evolving rapidly, leading to higher demand for mesna to prevent hemorrhagic cystitis[4].
  • Advancements in Chemotherapy: The ongoing research and development in chemotherapy, including new treatments and clinical trials, are contributing to the market's growth. The FDA's approval of new drugs also plays a significant role[4].
  • Expanded Use: Mesna is not only used for its FDA-approved indications but also for various off-label applications, such as reducing the incidence of cyclophosphamide-induced hemorrhagic cystitis and other conditions[5].

Market Segments

Product Type

  • Oral Mesna: The oral segment dominated the market during the forecast period, although oral doses must be doubled compared to IV doses due to bioavailability issues. This allows patients to leave the hospital sooner, reducing hospital stay times[4].
  • Injections: IV mesna is also widely used, especially in hospital settings where immediate administration is required.

Application

  • Hospital Pharmacies: Hospital pharmacies are a significant segment, given the frequent use of mesna in chemotherapy treatments within hospital settings[3][4].
  • Retail Pharmacies: Retail pharmacies hold the largest share of the market, with future pharmacies expected to incorporate more technology, such as telemedicine and point-of-care diagnostics[4].
  • Online Pharmacies: Online pharmacies are also growing, providing convenience and accessibility to patients.

Geographical Regions

  • North America: Expected to reach the largest share during the forecast period, driven by the high incidence of cancer and advanced healthcare infrastructure[4].
  • Europe and Asia-Pacific: These regions are also significant, with growing healthcare needs and increasing use of chemotherapy.

Financial Trajectory

Revenue Projections

  • The mesna market is projected to see substantial revenue growth from 2023 to 2031, with estimates suggesting a significant increase in market value measured in USD million across various segments[1][3][4].

Cost and Delivery

  • The cost of mesna, both in terms of the drug product and the cost of service delivery, is a critical factor. Health systems need to consider both the cost of goods and the cost to deliver the service, including operational and follow-up care costs[2].

Competitive Landscape

  • The market is competitive, with key players such as Sagent Pharmaceuticals, Athenex Pharmaceuticals, Fresenius Kabi, Baxter, and Mylan. These companies are focusing on product development, financial performance, and strategic expansions to maintain market share[4].

Challenges and Opportunities

Challenges

  • Regulatory and Pricing Pressures: The pharmaceutical industry faces regulatory challenges and pricing pressures, which can impact the profitability of mesna and other drugs[2].
  • Distribution Channels: The complexity of distribution channels, especially for high-cost and specialty drugs, can pose challenges. New distribution models and business strategies are emerging, which legacy models must adapt to[2].

Opportunities

  • Expanding Applications: The off-label use of mesna for various conditions presents opportunities for market expansion. Clinical trials and new treatment approvals also offer growth potential[5].
  • Technological Integration: The integration of technology in pharmacies, such as telemedicine and point-of-care diagnostics, can enhance the delivery and accessibility of mesna, driving market growth[4].

Key Takeaways

  • The mesna market is experiencing rapid growth driven by increasing cancer incidence and advancements in chemotherapy.
  • The market is segmented by product type, application, and geographical regions, with oral mesna and retail pharmacies being significant segments.
  • North America is expected to dominate the market due to its advanced healthcare infrastructure and high cancer incidence.
  • The financial trajectory of the mesna market is positive, with substantial revenue growth projected from 2023 to 2031.
  • Health systems must consider both the cost of goods and service delivery costs when managing mesna therapy.

FAQs

What is the primary use of mesna in medical treatment?

Mesna is primarily used as a prophylactic medication to reduce the incidence of ifosfamide-induced and cyclophosphamide-induced hemorrhagic cystitis in patients undergoing chemotherapy[5].

Which segment dominates the mesna market?

The oral segment dominates the mesna market, although IV mesna is also widely used, especially in hospital settings[4].

What are the key drivers of the mesna market growth?

The key drivers include the increasing incidence of cancer, advancements in chemotherapy, and the expanded use of mesna for various off-label applications[4].

Which region is expected to have the largest share of the mesna market?

North America is expected to reach the largest share during the forecast period due to its advanced healthcare infrastructure and high cancer incidence[4].

How does the cost of mesna impact its market dynamics?

The cost of mesna, including both the drug product and the cost of service delivery, is a critical factor. Health systems must consider these costs when managing mesna therapy[2].

Sources

  1. Market Research Intellect: Global Mesna Injection Market Size, Scope And Forecast Report.
  2. ASHP: Strategic Directions in System Formulary, Drug Policy, and High-Cost Drugs.
  3. Market Research Intellect: Global mesna mesnex market size and forecast.
  4. Verified Market Research: Mesna (Mesnex) Market Size, Share, Trends, Opportunities & Forecast.
  5. NCBI Bookshelf: Mesna - StatPearls.

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