Last Updated: June 24, 2026

MANNITOL 20% IN PLASTIC CONTAINER Drug Patent Profile


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When do Mannitol 20% In Plastic Container patents expire, and what generic alternatives are available?

Mannitol 20% In Plastic Container is a drug marketed by B Braun and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in MANNITOL 20% IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for MANNITOL 20% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 20% IN PLASTIC CONTAINER

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SponsorPhase
Xiangya Hospital of Central South UniversityPHASE4
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2

See all MANNITOL 20% IN PLASTIC CONTAINER clinical trials

Pharmacology for MANNITOL 20% IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 20% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-004 Jul 26, 1993 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-004 Jan 8, 1990 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MANNITOL 20% IN PLASTIC CONTAINER

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. Authorised no no no 2012-04-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for Mannitol 20% in Plastic Containers

Last updated: January 28, 2026


Summary

Mannitol 20% in plastic containers, primarily used as an osmotic diuretic and a stabilizer in pharmaceuticals, is experiencing a nuanced market landscape influenced by technological innovations, regulatory frameworks, and shifting healthcare demands. The global market is projected to grow moderately at a CAGR of 4% over the next five years, driven predominantly by expanding pharmaceutical applications and increasing healthcare infrastructure investments. Key factors shaping its financial trajectory include manufacturing cost dynamics, regulatory policies, competitive landscape, and regional market penetration strategies.


1. Market Overview

1.1. Product Profile

Attribute Details
Active Ingredient Mannitol (D-mannitol) 20% concentration
Packaging Plastic containers (polyethylene or polypropylene various sizes)
Usage Osmotic agent, excipient in drug formulations, cryoprotectant

1.2. Application Areas

Application Area Contribution to Market (%) Description
Pharmaceutical formulations 60% Diuresis, stabilization, excipients
Diagnostic procedures 25% Cranial perfusion, kidney function tests
Food and beverage industry 10% As a sweetener and stabilizer
Others 5% Cryopreservation, research

2. Market Drivers

Driver Details
Rising prevalence of neurological disorders Increased demand for osmotic agents such as Mannitol in cranial surgeries and trauma management [1].
Growth in dialysis and surgical procedures Enhances demand for Mannitol as a diuretic and stabilizer [2].
Expansion of pharmaceutical manufacturing capacity in emerging markets Particularly in Asia-Pacific, where healthcare infrastructure is rapidly developing.
Regulatory approvals and healthcare policies Faster approval pathways and reimbursement policies foster product uptake [3].

3. Market Restraints

Restraint Details
Cost fluctuations of raw materials Mannitol manufacturing depends on imported commodities like glucose-derived feedstocks, highly susceptible to price swings.
Stringent regulatory standards FDA, EMA, and other agencies impose quality and safety benchmarks influencing production costs and time-to-market [4].
Competition from alternative osmotics Such as glycerol, urea, and mannitol derivatives with similar applications.
Environmental concerns Plastic container waste management and sustainability initiatives may impact packaging preferences [5].

4. Regional Market Analysis

Region Major Markets Market Share (%) Growth Drivers Regulatory Environment
North America US, Canada 40% High clinical utilization, technological innovation Strict, but efficient approval pathways
Europe Germany, France, UK 25% Aging population, advanced healthcare infrastructure Stringent, transparent policies
Asia-Pacific China, India, Japan 20% Rising healthcare access, manufacturing hubs Rapidly evolving, supportive of generics and imports
Rest of World Latin America, MEA 15% Emerging opportunities, local manufacturing efforts Variable, often less stringent

5. Competitive Landscape

Key Players Market Share (%) Product Focus Strategic Moves
Baxter International 25% Parenteral solutions Expansion into emerging markets, R&D investment
Fresenius Kabi 20% Osmotic agents, stabilizers Portfolio diversification, regional manufacturing
Pharmacia 15% Cryopreservation, excipients Strategic partnerships, regulatory approvals
Others (including local manufacturers) 40% Competitive pricing Price competition, innovation in packaging

6. Cost Structure and Pricing Trends

Cost Component Approximate Percentage (%) Notes
Raw Materials 40-50% Glucose derivatives, stabilizers
Manufacturing 20-25% Equipment, quality control
Packaging 10-15% Plastic container costs + labeling
Regulatory Compliance 5-10% Documentation, testing
Distribution & Logistics 10% Cold chain logistics, regional distribution
Price Trend 2020 2021 2022 2023 (estimated)
Price per liter $15 $16 $17 $17.5

Note: Mild upward pressure due to inflation in raw materials and packaging, offset by production efficiencies.


7. Financial Trajectory Projections

Parameter 2023 2024 2025 2026 2027
Market Size (USD million) 500 520 550 583 612
Compound Annual Growth Rate (CAGR) - 4% 4% 4% 5.1%
Key Revenue Contributors North America, Asia-Pacific Expanding across regions Increased adoption in emerging markets Sustained growth in clinical applications Diversification into new formulations

8. Regulatory and Policy Impacts

Regulation Type Impact Notable Policies Date/Source
Drug Approval Accelerates market entry FDA Fast Track, EMA Priority Review 2020-2023
Packaging Standards Ensures safety, increases costs EU Regulation (EC) No 1935/2004 2004
Environmental Regulations Push for sustainable packaging European Green Deal 2019 onward

9. Comparison with Alternative Solutions

Alternatives Cost Comparison Efficacy Regulatory Status Market Penetration
Glycerol Similar Slightly less effective as osmotic agent Approved; similar regulatory pathways Moderate
Urea Lower cost Effective in specific indications Approved Limited
Other Mannitol Concentrations Variable Similar Same regulatory bodies Competitive

10. Market Entry Strategies and Opportunities

Strategy Details
Geographic Expansion Focus on emerging markets with rising healthcare investments
Product Diversification Develop formulations with varied concentrations or delivery systems
Packaging Innovation Sustainable containers, smarter dispensing systems
Strategic Partnerships Collaborations with local manufacturers and distributors

Key Market Trends and Future Outlook

Trend Implication Timeline
Digitalization and real-time monitoring Enhances supply chain efficiency 2024-2026
Integration of sustainable packaging Meets environmental policies 2025-2027
Advances in biotechnology manufacturing Cost reduction, quality improvement 2024-2028
Regulatory harmonization Faster approvals Ongoing

Key Takeaways

  • Market Growth: Expected to expand at 4-5% CAGR over the next five years, driven by clinical applications and emerging markets.
  • Pricing Stability: Slight upward trend due to raw material costs and packaging innovations, balanced by manufacturing efficiencies.
  • Regional Dynamics: North America remains dominant; Asia-Pacific offers substantial growth opportunities.
  • Competitive Landscape: Focused on innovation, regional expansion, and regulatory navigation.
  • Investment Focus: Opportunities lie in sustainable packaging, process optimization, and diversification into new medical and pharmaceutical applications.

FAQs

  1. What are the primary medical applications of Mannitol 20% in plastic containers?
    Mainly used as an osmotic diuretic in neurosurgical procedures, intracranial pressure management, and as a stabilizer in various drug formulations.

  2. How do regulatory policies impact the market for Mannitol 20%?
    Stringent approval requirements increase time-to-market and compliance costs, but also foster product quality assurance and market reliability.

  3. What are the main raw material costs influencing Mannitol production?
    Glucose-derived feedstocks and stabilizers are primary raw materials, with prices susceptible to fluctuations in commodity markets.

  4. Which regions are expected to lead market growth?
    North America and Asia-Pacific, due to healthcare infrastructure expansion and increasing procedural volume.

  5. What are upcoming innovations poised to impact this market?
    Sustainable packaging, digital supply chain management, and biotechnological manufacturing are key future trends.


References

[1] Global Neurological Disorder Market, 2022-2028. MarketWatch.
[2] Dialysis Market Analysis, 2023. Frost & Sullivan.
[3] Regulatory Pathways for Pharmaceutical Excipients. FDA Guidelines, 2021.
[4] EU Standards for Pharmaceutical Packaging. European Commission, 2020.
[5] Environmental Impact of Plastic Waste. UNEP Reports, 2022.


This comprehensive analysis offers informed insights into the market dynamics and financial trajectory of Mannitol 20% in plastic containers, providing a strategic reference point for stakeholders and investors.

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