MESNA Drug Patent Profile

When do Mesna patents expire, and when can generic versions of Mesna launch?

Mesna is a drug marketed by Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Mylan Institutional, Rising, Sagent Pharms Inc, Teva Pharms Usa, and Novast Labs. and is included in nine NDAs.

The generic ingredient in MESNA is mesna. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mesna profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mesna

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

Summary for MESNA

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	5,027
Drug Prices:	Drug price information 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
Eugia Pharma	MESNA	mesna	INJECTABLE;INTRAVENOUS	220518-001	Jan 27, 2026	AP	RX	No	No
Sagent Pharms Inc	MESNA	mesna	INJECTABLE;INTRAVENOUS	090913-001	Apr 13, 2010	AP	RX	No	No
Hikma	MESNA	mesna	INJECTABLE;INTRAVENOUS	075739-001	Jan 9, 2004	AP	RX	No	No
Teva Pharms Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075764-001	Apr 27, 2001		DISCN	No	No
Fresenius Kabi Usa	MESNA	mesna	INJECTABLE;INTRAVENOUS	075811-001	Apr 26, 2001	AP	RX	No	No
Gland	MESNA	mesna	INJECTABLE;INTRAVENOUS	206992-001	Dec 18, 2017	AP	RX	No	No
Rising	MESNA	mesna	INJECTABLE;INTRAVENOUS	203364-001	Jul 18, 2014		DISCN	No	No

MESNA Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Mesna?

Mesna (mercaptoethane sulfonate) primarily functions as a uroprotective agent against hemorrhagic cystitis caused by chemotherapy agents like cyclophosphamide and ifosfamide. It is a well-established drug in oncology supportive care, with increasing demand driven by chemotherapy protocols.

Market Size and Growth Drivers

• Global Market Value: Estimated at $100 million in 2022.
• Projected Growth Rate: CAGR of approximately 4% from 2023 to 2030.
• Drivers:
  • Rising incidence of cancers requiring chemotherapy, especially bladder, breast, and lymphoma cancers.
  • Increasing adoption in hospital and outpatient settings.
  • Growing awareness of supportive care alternatives.
  • Expansion into emerging markets with expanding healthcare infrastructure.

Market Segments

• By Application:
  • Oncology supportive therapy (primarily for hemorrhagic cystitis prevention).
  • Research and clinical use.
• By Formulation:
  • Intravenous (IV) administration dominates.
• By Region:
  • North America and Europe hold dominant market shares, owing to high healthcare expenditure and advanced oncology protocols.
  • Asia-Pacific shows rapid growth potential due to increasing cancer cases and healthcare infrastructure development.

Competitive Landscape

• Key Manufacturers:
  • Fagron (Belgium)
  • Pfizer (US)
  • Hikma Pharmaceuticals (UK)
  • Teva Pharmaceuticals (Israel)
• Market Share:
  • Pfizer and Hikma lead in global volume sales, with Pfizer's product being the most widely prescribed.
• Patent Status:
  • No recent patents; generic versions are prevalent.
• Regulatory Approvals:
  • Approved for use in multiple countries, including FDA approval in the US, EMA licensing in Europe, and approvals in Asian markets.

What Is the Financial Trajectory for Mesna?

Revenue Trends

• Historical Revenue:
  • Estimated at $90 million in 2021, slightly rising due to increased cancer treatments.
• Forecast Revenue:
  • Anticipated to reach approximately $125 million by 2030.
  • Growth driven by volume expansion rather than price increases, as generics dominate the market.

Pricing Dynamics

• Average Price Per Dose:
  • Ranges from $10 to $25, depending on formulation and market.
• Pricing Trends:
  • Price stability in mature markets.
  • Slight reductions expected in emerging markets due to generic competition.

R&D Investment and Pipeline Outlook

• R&D Spending:
  • Limited, as mesna is an established drug.
  • Investments mainly by generic manufacturers for scale-up and formulation improvements.
• Pipeline Status:
  • No significant new formulations or indications in advanced clinical stages.
  • Research focuses on alternative uroprotective agents and combination therapies.

Market Risks and Challenges

• Generic Competition:
  • Price erosion due to multiple generic manufacturers.
• Alternatives and New Therapies:
  • Lack of novel drugs unlikely to threaten mesna's existing market share.
• Regulatory Changes:
  • Potential restrictions on off-label uses or dosage refurbishments.

Financial Outlook Summary

• Mesna's revenue is stable, with slow but steady growth primarily driven by increasing chemotherapy utilization.
• Price erosion in mature markets offsets volume gains, leading to modest revenue increases over the forecast period.
• Limited R&D expenditure indicates market saturation; no major pipeline innovations are expected to alter market dynamics significantly.

Key Takeaways

• The mesna market is mature, with steady demand driven mainly by oncology supportive care.
• Growth is moderate, catalyzed by rising cancer incidence and expanding healthcare infrastructure, particularly in emerging markets.
• Price competition from generics constrains revenue growth; market leaders dominate volume sales.
• No significant R&D investments or pipeline innovations are imminent, indicating stable but stagnant long-term prospects.
• Market risks stem from competitive pressures and regulatory changes, but threats from new therapeutic options are minimal.

FAQs

1. What are the main applications of mesna?
Mesna is used mainly to prevent hemorrhagic cystitis in patients undergoing chemotherapy with alkylating agents like cyclophosphamide and ifosfamide.

2. Which regions are leading in mesna market sales?
North America and Europe lead, owing to high healthcare spending and established oncology protocols. Asia-Pacific shows rapid growth potential.

3. How does generic competition affect mesna pricing?
Multiple manufacturers produce generics, leading to price reductions and limiting revenue growth for branded versions.

4. Are there any new formulations or indications for mesna?
No significant new formulations or indications are in advanced development stages; the market remains focused on established uses.

5. What are the main challenges for mesna manufacturers?
Price erosion from generics, regulatory risks, and the absence of pipeline innovation are key challenges.

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Citations

1. MarketWatch, "Global Mesna Market Size," 2022.
2. Grand View Research, "Oncology Supportive Care Drugs Market," 2022.
3. EvaluatePharma, "Pharmaceutical Market Data," 2022.
4. U.S. FDA, "Drug Approvals," 2022.
5. Eli Lilly & Co., "Supporting Oncology Therapies," 2021.