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Last Updated: December 12, 2025

MANNITOL 10% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Mannitol 10% In Plastic Container, and when can generic versions of Mannitol 10% In Plastic Container launch?

Mannitol 10% 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 10% IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for MANNITOL 10% IN PLASTIC CONTAINER
Drug patent expirations by year for MANNITOL 10% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 10% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2
Laval UniversityNA

See all MANNITOL 10% IN PLASTIC CONTAINER clinical trials

Pharmacology for MANNITOL 10% IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 10% 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 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-002 Jul 26, 1993 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-002 Jan 8, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 10% 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 10% in Plastic Container

Last updated: July 30, 2025

Introduction

Mannitol 10% in plastic containers occupies a strategic niche within the pharmaceutical and medical markets primarily as an osmotic diuretic and neuroprotective agent. Its applications extend from cerebral edema management to urinary excretion enhancement, positioning it as a vital drug in emergency and intensive care settings. As the healthcare landscape evolves with technological advances and increasing demand for hospital-grade formulations, understanding the market dynamics and projected financial trajectories for Mannitol 10% in plastic containers becomes essential for stakeholders, including manufacturers, investors, and healthcare providers.

Market Overview

Global Market Size and Growth Trends.

The global demand for Mannitol 10% solutions, especially in sterile plastic containers, is driven by the rising incidence of neurological disorders, trauma, and surgeries requiring osmotherapy. As per recent industry reports, the global mannitol market was valued at approximately USD 230 million in 2021, with an expected compound annual growth rate (CAGR) of around 4-5% through 2028 [1]. The adoption of ready-to-use plastic container formulations aligns with the broader trend towards sterile, risk-reduced infusion therapies, further propelling market growth.

Market Segments and Key Drivers.

  • End-Use Industries: Hospital pharmacies, ICU units, emergency medical services, and surgical centers predominantly utilize Mannitol 10% in plastic containers.
  • Geographic Variability: North America leads due to advanced healthcare infrastructure and high neurological disease prevalence, followed by Europe and parts of Asia-Pacific, notably China and India, where expanding healthcare access fuels growth.
  • Regulatory Environment: Stringent manufacturing standards, such as compliance with USP and EP specifications, influence market stability. Governments incentivize sterile packaging innovations to improve patient safety, driving demand for plastic container formulations.
  • Innovation in Packaging: The shift toward prefilled, ready-to-use plastic containers enhances convenience, reduces contamination risk, and aligns with infection control protocols—augmenting market attractiveness.

Market Dynamics

Supply Chain and Manufacturing Factors

The manufacturing of Mannitol 10% solutions in plastic containers necessitates high-grade sterile environments and adherence to Good Manufacturing Practices (GMP). Increased investment in innovative packaging technologies, such as blow-fill-seal (BFS) systems, ensures sterility and cost-effectiveness. The integration of continuous manufacturing processes enhances efficiency and scalability, positively influencing supply chain robustness and agility.

Regulatory and Quality Standards

The regulatory landscape shapes market dynamics significantly. Approval processes in major markets require comprehensive safety, efficacy, and stability data. Recent trends indicate a push for improved container materials—such as medical-grade polyethylene and polypropylene—to prevent leaching and ensure stability of mannitol solutions over shelf life, supporting market expansion [2].

Competitive Landscape

The market features major players like Baxter International, Pfizer, and Fresenius Kabi, investing heavily in R&D and sterile packaging innovations. The entry of regional manufacturers catering to domestic markets offers price competitiveness but faces barriers in compliance and quality assurance. Mergers, acquisitions, and strategic collaborations are prevalent to capture larger market shares and expand product portfolios.

Pricing and Reimbursement Trends

Pricing strategies are influenced by manufacturing costs, regulatory compliance, and market competition. In developed markets, reimbursement policies favor high-quality, prefilled sterile solutions, enabling premium pricing. Conversely, price sensitivity in emerging markets necessitates cost-efficient manufacturing and affordable formulations to penetrate the market effectively.

Impact of Emerging Technologies

Advancements in container materials, such as UV-protective plastics and oxygen barriers, extend product shelf life and maintain stability, offering competitive advantages. Additionally, developments in infusion pump compatibility and smart packaging integrate with digital health initiatives, offering opportunities for value-added services and improved patient outcomes.

Financial Trajectory Analysis

Revenue Forecasts

Based on current market trends and emerging demand, revenue for Mannitol 10% in plastic containers is projected to grow at a CAGR of approximately 4.2% through 2028. This growth is driven by increasing global healthcare expenditures, rising neurological disease incidence, and the adoption of sterile, prefilled containers in critical care.

Profitability and Cost Dynamics

Major cost components include raw materials (pharmacological grade mannitol, plastic resins), manufacturing operational expenses, and regulatory compliance costs. Economies of scale achieved via high-volume manufacturing, coupled with process automation, are expected to improve profit margins over time. Strategic sourcing and material innovations can further optimize costs.

Market Entry and Expansion Strategies

Emerging markets present lucrative opportunities due to unmet needs and expanding healthcare access. Companies adopting localized manufacturing, partnerships with healthcare providers, and tailored pricing structures can shorten time-to-market and increase revenue streams.

Risks and Challenges

Market growth faces challenges such as fluctuating raw material prices, stringent regulatory hurdles, and competition from alternative osmotic agents. Additionally, supply chain disruptions, especially in the context of global crises, can impact manufacturing continuity and financial performance.

Conclusion

Mannitol 10% in plastic containers is poised for steady growth over the coming years, supported by technological advancements, regulatory improvements, and mounting clinical demand. Strategic investments in sterile manufacturing processes, innovative packaging, and targeted market expansion are critical to capturing value and optimizing financial outcomes. Ensuring compliance with evolving standards and leveraging emerging technological trends will be key drivers of sustained profitability.


Key Takeaways

  • Growth Potential: The Mannitol 10% market in plastic containers is projected to grow at a CAGR of around 4-5% through 2028, driven by increased clinical adoption and healthcare infrastructure expansion.
  • Innovation Focus: Packaging innovations, such as prefilled sterile containers using BFS technology, enhance safety, convenience, and market competitiveness.
  • Regulatory Impact: Regulatory standards governing sterilization, container materials, and stability are pivotal, influencing market access and product differentiation.
  • Cost Optimization: Economies of scale, supply chain efficiencies, and raw material sourcing are central to maintaining profitability amid competitive pressures.
  • Market Entry Strategies: Localized manufacturing and strategic collaborations in emerging markets can catalyze growth and diversify revenue streams.

FAQs

1. What are the primary clinical applications of Mannitol 10% in plastic containers?
Mannitol 10% solutions are primarily used for managing cerebral edema, reducing intracranial pressure, and serving as an osmotic diuretic in critical care settings.

2. How does packaging innovation influence the market for Mannitol solutions?
Innovative sterile plastic containers, especially prefilled and FDA-approved formats, improve safety, reduce preparation time, and meet infection control standards—driving demand and premium positioning.

3. What are the major regulatory considerations for Mannitol 10% solutions?
Manufacturers must comply with pharmacopeial standards (e.g., USP, EP), ensure container safety and stability, and obtain approvals from agencies such as the FDA and EMA, which can influence market entry and pricing.

4. Which regions are experiencing the fastest growth in Mannitol market demand?
Emerging markets in Asia-Pacific, especially China and India, are witnessing rapid growth driven by expanding healthcare access, increased neurological disease burden, and infrastructural investments.

5. What are the key risks affecting the financial trajectory of Mannitol 10% in plastic containers?
Market risks include raw material price volatility, regulatory delays, competition from alternative therapies, and supply chain disruptions, all potentially impacting revenues and profitability.


Sources
[1] Market Research Future, "Global Mannitol Market Forecast," 2022.
[2] Pharmaceutical Packaging Solutions, "Innovation in Sterile Container Materials," 2021.

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