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, Baxter Hlthcare, and Novast Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for mesna

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	5,785
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
Sagent Pharms Inc	MESNA	mesna	INJECTABLE;INTRAVENOUS	090913-001	Apr 13, 2010	AP	RX	No	No
Gland	MESNA	mesna	INJECTABLE;INTRAVENOUS	206992-001	Dec 18, 2017	AP	RX	No	No
Novast Labs	MESNA	mesna	TABLET;ORAL	218871-001	Jan 13, 2025	AB	RX	No	No
Hikma	MESNA	mesna	INJECTABLE;INTRAVENOUS	075739-001	Jan 9, 2004	AP	RX	No	No
Fresenius Kabi Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075811-001	Apr 26, 2001	AP	RX	No	No
Mylan Institutional	MESNA	mesna	INJECTABLE;INTRAVENOUS	076488-001	Mar 8, 2012		DISCN	No	No
Baxter Hlthcare	MESNEX	mesna	INJECTABLE;INTRAVENOUS	019884-001	Dec 30, 1988	AP	RX	Yes	Yes

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Mesna

Last updated: July 27, 2025

Introduction

Mesna (2-mercaptoethane sulfonate) is a thiol compound widely used in medical oncology to mitigate and prevent hemorrhagic cystitis caused by alkylating agents such as ifosfamide and cyclophosphamide. Its pharmacological action involves binding acrolein— a urotoxic metabolite— thus safeguarding the bladder mucosa. As the demand for chemoprotective agents grows within oncology, mesna's market landscape is evolving, influenced by therapeutic advancements, regulatory pathways, and competitive forces.

This report analyzes the current market dynamics, future financial trajectory, and key factors influencing mesna's commercial growth, providing actionable insights for industry stakeholders.

Market Overview

Global Market Size and Growth Trends

The global mesna market was valued at approximately USD 250 million in 2022, with projections indicating a compound annual growth rate (CAGR) of 5-7% through 2030 [1]. The expanding use of chemotherapy in cancer therapy, especially in hematologic malignancies and solid tumors, underpins sustained growth. Increasing awareness regarding the importance of uroprotective agents further bolsters demand.

Regional Perspectives

North America and Europe currently dominate the mesna market— attributed to well-established oncology treatment protocols, high healthcare expenditure, and comprehensive regulatory approvals. The Asia-Pacific region exhibits significant growth potential driven by increasing cancer prevalence, improving healthcare infrastructure, and rising adoption of chemotherapeutic regimens.

Clinical Adoption and Prescriptions

Mesna is integral in protocols involving hemorrhagic cystitis prevention. Its preference over older, less effective agents, and the incorporation into combination therapies, sustain its prescription rates. The rise of outpatient chemotherapy centers further amplifies demand for prophylactic agents like mesna.

Market Drivers

Growing Cancer Incidence and Chemotherapy Use

Cancer prevalence worldwide is rising, with the World Health Organization estimating 19.3 million new cases in 2020 [2]. As chemotherapy remains a cornerstone of treatment, the concomitant need for protective agents like mesna is expanding.

Advancements in Oncology Drug Protocols

Increased utilization of high-dose alkylating agents, particularly in hematopoietic stem cell transplantation and pediatric oncology, enhances mesna’s necessity. The evolution of personalized medicine also influences prescribing patterns favoring supportive care agents.

Regulatory Approvals and Expanded Indications

Regulatory agencies such as the FDA and EMA have approved mesna for various indications, and ongoing clinical trials exploring broader applications may further enhance its market reach.

Generic Market Entry and Price Competition

The patent landscape for mesna is mature, with multiple generics available, leading to reduced drug prices and increased accessibility, especially in emerging markets.

Market Challenges

Availability of Alternatives and Adjuncts

While mesna is the standard uroprotective agent, emerging compounds and adjunct therapies, such as hydration protocols and alternative uroprotectants, pose competitive threats.

Cost and Healthcare Policy Constraints

Price sensitivity in some regions, coupled with healthcare budget constraints, impact procurement and prescription trends.

Regulatory and Manufacturing Challenges

Ensuring consistent quality, particularly for generic manufacturers, and navigating regulatory re-certifications pose ongoing operational challenges.

Financial Trajectory and Future Outlook

Revenue Projections

Given current growth rates, the mesna market is expected to reach USD 350-400 million globally by 2030. The CAGR of approximately 6% reflects the steady adoption in oncology care, especially in emerging markets and expanding indications.

Impact of Innovation and Clinical Research

Emerging evidence supporting prophylactic use in novel chemotherapeutic combinations and ongoing trials exploring new indications (e.g., mitigation of toxicity in targeted therapies) may catalyze incremental revenue gains.

Potential Market Disruptors

Innovations in supportive care modalities, including the development of non-thiol-based uroprotectants or personalized chemoprotection strategies, could alter the growth trajectory.

Manufacturing and Pricing Strategies

Strategic investments in manufacturing efficiency, quality assurance, and competitive pricing will remain critical to market share retention and expansion, particularly among generic producers.

Regulatory Landscape and Market Access

Regulatory approvals are robust in developed regions, with prescriptive guidelines favoring mesna's use. In developing regions, approval processes are progressing, driven by international health initiatives and patent expirations. Market access initiatives, including insurance reimbursement and subsidies, will significantly influence sales trajectories.

Competitive Landscape

Major pharmaceutical companies such as Baxter International and generic manufacturers dominate the market. Collateral partnerships, licensing agreements, and geographic expansion strategies are key competitive tactics observed within this space.

Conclusion

Mesna's market sustains growth driven by the increasing burden of cancer, evolving chemotherapy protocols, and supportive care emphasis. Its financial trajectory appears favorable with consistent demand, although competition and healthcare policy modify growth nuances. Companies that optimize manufacturing, expand indications, and adapt to regulatory environments will capitalize on the lucrative outlook.

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Key Takeaways

• The global mesna market is expected to grow at a CAGR of approximately 6% through 2030, reaching USD 350-400 million.
• Rising cancer incidence and chemotherapy prevalence underpin sustained demand.
• Generic manufacturing and price competitiveness will remain pivotal to market penetration.
• Regulatory approvals facilitate global expansion, especially in emerging economies.
• Innovations in supportive care may influence future market dynamics, warranting ongoing research and development.

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FAQs

1. What are the primary factors driving mesna demand?
Increasing cancer cases, widespread use of alkylating chemotherapeutic agents, and emphasis on supportive care to mitigate side effects primarily drive demand.

2. How does the patent landscape influence mesna's market?
Patent expirations enable generic manufacturers to enter the market, increasing affordability and access, especially in developing regions.

3. Are there emerging alternatives to mesna for uroprotection?
Current alternatives are limited; hydration protocols and other uroprotective agents exist but are less established. Ongoing research explores novel compounds, but mesna remains the standard.

4. How does regional variation affect mesna's market growth?
Developed regions benefit from high adoption rates and established protocols. Growing healthcare infrastructure and cancer prevalence in emerging economies suggest significant future growth.

5. What is the impact of clinical research on mesna's market?
Clinical trials exploring new indications and optimized dosing strategies can expand usage, positively influencing market growth.

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References
[1] MarketsandMarkets. (2022). Pharmaceuticals Market by Type, Application, and Region.
[2] WHO. (2020). Cancer Fact Sheet.