MESNA - Generic Drug Details

What are the generic sources for mesna and what is the scope of patent protection?

Mesna is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Gland, Hikma, Mylan Institutional, Rising, Sagent Pharms Inc, Teva Pharms Usa, and Baxter Hlthcare, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for mesna. Six suppliers are listed for this compound.

Summary for MESNA

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	9
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	120
Patent Applications:	2,468
Drug Prices:	Drug price trends for MESNA
What excipients (inactive ingredients) are in MESNA?	MESNA excipients list
DailyMed Link:	MESNA at DailyMed

See drug prices for MESNA

Pharmacology for MESNA

Drug Class

Cytoprotective Agent

Medical Subject Heading (MeSH) Categories for MESNA

Protective Agents

Anatomical Therapeutic Chemical (ATC) Classes for MESNA

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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
Mylan Institutional	MESNA	mesna	INJECTABLE;INTRAVENOUS	076488-001	Mar 8, 2012		DISCN	No	No
Rising	MESNA	mesna	INJECTABLE;INTRAVENOUS	203364-001	Jul 18, 2014		DISCN	No	No
Fresenius Kabi Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075811-001	Apr 26, 2001	AP	RX	No	No
Teva Pharms Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075764-001	Apr 27, 2001		DISCN	No	No
Baxter Hlthcare	MESNEX	mesna	TABLET;ORAL	020855-001	Mar 21, 2002		RX	Yes	Yes
Hikma	MESNA	mesna	INJECTABLE;INTRAVENOUS	075739-001	Jan 9, 2004	AP	RX	No	No

Expired US Patents for MESNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	MESNEX	mesna	INJECTABLE;INTRAVENOUS	019884-001	Dec 30, 1988	4,220,660
Baxter Hlthcare	MESNEX	mesna	TABLET;ORAL	020855-001	Mar 21, 2002	5,262,169
Baxter Hlthcare	MESNEX	mesna	TABLET;ORAL	020855-001	Mar 21, 2002	5,252,341
Baxter Hlthcare	MESNEX	mesna	INJECTABLE;INTRAVENOUS	019884-001	Dec 30, 1988	5,696,172

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.