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Last Updated: December 12, 2025

MANNITOL 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Mannitol 5% In Plastic Container, and when can generic versions of Mannitol 5% In Plastic Container launch?

Mannitol 5% 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 5% 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 5% IN PLASTIC CONTAINER
Drug patent expirations by year for MANNITOL 5% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 5% IN PLASTIC CONTAINER

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

SponsorPhase
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2
Laval UniversityNA

See all MANNITOL 5% IN PLASTIC CONTAINER clinical trials

Pharmacology for MANNITOL 5% IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 5% 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 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-001 Jul 26, 1993 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl MANNITOL 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-001 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 5% 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 5% in Plastic Container

Last updated: August 2, 2025

Introduction

Mannitol 5% in plastic containers represents a critical segment within the pharmaceutical and hospital infrastructure landscape, primarily used as an osmotic diuretic and cerebral edema reducer. Its versatility in clinical settings, coupled with increasing demand for intravenous (IV) solutions, positions this product as a vital healthcare asset. This analysis explores the market forces, growth drivers, challenges, and financial forecasts associated with Mannitol 5%, focusing particularly on the implications of its packaging format—plastic containers—on market dynamics and profitability.

Market Overview and Industry Context

Mannitol is a sugar alcohol utilized intensively in medical treatments for its osmotic properties. The 5% concentration solution in plastic containers caters to hospitals and clinics favoring convenience, safety, and stability associated with molded plastic packaging. The global demand correlates with the expansion of healthcare infrastructure, rising incidence of neurological conditions requiring osmotherapy, and the preference for pre-filled or ready-to-use IV solutions.

The pharmaceutical landscape is experiencing rapid growth propelled by aging populations, increasing prevalence of chronic diseases (e.g., stroke, traumatic brain injury), and advances in hospital treatment protocols. The global market for Mannitol was valued at approximately USD 250 million in 2022, with projections to reach USD 370 million by 2030 [1].

Market Drivers

1. Increasing Clinical Applications

Mannitol’s primary use in managing cerebral edema, glaucoma, and renal failure sustains consistent demand. Neurological conditions, notably stroke and brain trauma, are surging globally, fostering incremental use of Mannitol in intensive care units (ICUs).

2. Growth in Healthcare Infrastructure

Developing regions such as Asia-Pacific exhibit significant investments in healthcare expansion, leading to broader access and increased procurement of IV pharmaceuticals, including Mannitol. Enhancements in hospital capacity, IV infusion services, and storage facilities catalyze demand.

3. Patient Safety and Packaging Innovation

Plastic containers offer superior safety compared to glass, reducing breakage risk, contamination, and facilitating easier transportation and storage. Manufacturers favor polyethylene or polypropylene containers, aligning with stringent safety and sterility standards.

4. Regulatory and Reimbursement Policies

Stringent regulatory frameworks for injectable pharmaceuticals, coupled with favorable reimbursement models for hospital-administered drugs, promote consistent consumption. Standardized packaging methods streamline procurement processes.

5. Market Expansion through Generic Drug Adoption

Patent expirations and the rise of generic manufacturers result in competitive pricing, expanding access especially in emerging markets. Cost-effective options catalyze broad adoption in resource-constrained settings.

Market Challenges

1. Raw Material Price Fluctuations

Manufacturing Mannitol relies on complex carbohydrate processing, susceptible to commodity price swings, impacting profit margins.

2. Regulatory Hurdles

Stringent approval processes, especially regarding manufacturing standards, packaging safety, and sterility, impede rapid market entry and expansion.

3. Competition from Alternative Osmotic Agents

Emerging therapeutic agents and alternative osmotic diuretics may reduce Mannitol’s market share. Innovations in drug delivery could further impact demand.

4. Packaging Sustainability Concerns

Increasing regulatory and consumer focus on environmentally sustainable packaging may challenge reliance on conventional plastic containers, prompting innovation and potentially higher costs.

Financial Trajectory Projections

Market Revenue Forecasts

Based on compound annual growth rate (CAGR) estimations of approximately 5.5% from 2022 to 2030, driven predominantly by regional expansion and clinical demand, the global Mannitol 5% market in plastic containers could surpass USD 370 million by 2030 [1].

Regional Growth Analysis

  • North America: Dominates due to advanced healthcare infrastructure, regulatory rigor, and high per capita healthcare spending. Expected CAGR of 4.5% owing to technological upgrades and clinical research.

  • Europe: Similar growth trajectory with emphasis on compliance and safety standards, with CAGR near 4.8%.

  • Asia-Pacific: fastest-growing segment, projected at approximately 6.8% CAGR, driven by economic development, increased hospital capacity, and rising neurological disorder prevalence.

  • Latin America and MEA: Emerging markets exhibit steady growth (~5-6%), primarily through increased hospital investments and generics penetration.

Profitability Trends

Manufacturers adopting cost-efficient production methods, leveraging bulk procurement of raw materials, and optimizing supply chain logistics will enhance margins. The shift towards reusable, environmentally friendly packaging may elevate initial costs but offer long-term savings and market competitiveness.

Pricing Dynamics

Increased competition, especially from generic producers, is expected to exert downward pressure on unit prices. However, innovations in packaging and supply chain efficiencies help maintain profit streams.

Distribution and Supply Chain Factors

Ensure steady supply chains resilient to geopolitical, logistical, or raw material disruptions. Centralized manufacturing hubs in strategic regions support cost-effective distribution.

Regulatory and Patent Landscape

Orientation towards standardization and quality assurance under agencies like the FDA, EMA, and other national authorities influences market entry and pricing. Patent expiries for branded formulations pave the way for generics, intensifying competition.

Impact of Packaging Format (Plastic Containers)

The transition from glass to plastic containers for Mannitol 5% solutions aligns with global safety and efficacy standards. Plastic packaging provides benefits such as lightweight handling, reduced breakage, and compatibility with various infusion devices. However, sustainability pressures and regulatory scrutiny over plastic waste management demand ongoing innovation in biodegradable or recyclable materials, potentially restructuring market dynamics.

Key Market Players and Competitive Strategies

Major manufacturers include Fresenius Kabi, B. Braun Melsungen AG, Hospira (now part of Pfizer), and local/regional generic producers. Competitive strategies focus on:

  • Investment in manufacturing capacity expansion.
  • Diversifying packaging options with sustainable materials.
  • Ensuring regulatory compliance.
  • Cost leadership via supply chain optimization.

Future Outlook and Opportunities

The growing awareness of environmental impacts prompts innovations in biodegradable plastics. Additionally, increasing digitization and supply chain transparency present opportunities for integrated logistics, real-time inventory management, and enhanced market reach.

Emerging markets’ accession to quality standards and importation policies expand global market access. Clinical research investments may reveal novel therapeutic applications, broadening demand.

Key Takeaways

  • The global Mannitol 5% market in plastic containers is poised for stable growth (~5.5% CAGR), driven chiefly by expanding healthcare infrastructure and clinical demand for osmotherapy.

  • Asia-Pacific emerges as a lucrative growth zone, owing to economic growth and demographic shifts. Developed markets such as North America and Europe will sustain steady demand with high regulatory standards.

  • Packaging advancements towards eco-friendly and safety-enhanced plastic containers are critical to maintaining market share and compliance.

  • Cost management, supply chain resilience, and innovation in sustainable packaging are crucial for profitability.

  • Regulatory landscapes and patent expirations will shape competitive dynamics, fostering increased generic penetration.

FAQs

Q1: What factors influence the pricing of Mannitol 5% in plastic containers?

A: Pricing is primarily affected by raw material costs, competition from generics, regulatory compliance costs, and supply chain efficiencies. Increased competition tends to lower prices, while packaging innovations and quality standards impact manufacturing expenses.

Q2: How does sustainable packaging impact the Mannitol market?

A: Emphasis on reducing plastic waste compels manufacturers to adopt biodegradable or recyclable materials. While initially increasing costs, sustainable packaging can enhance brand reputation and meet regulatory requirements, ultimately impacting profitability and market positioning.

Q3: What are the main regions for Mannitol 5% market growth?

A: North America and Europe are mature, with steady demand. Asia-Pacific is the fastest-growing due to healthcare expansion, infrastructural development, and rising neurological illnesses.

Q4: How do patent expiries influence the Mannitol market?

A: Patent expirations enable generic manufacturers to produce cost-effective alternatives, increasing market competition and reducing prices, which benefits healthcare providers and patients but pressures branded product revenues.

Q5: What clinical advancements could expand Mannitol's market?

A: Innovations in formulations, delivery methods, or new indications such as combination therapies for neurological or renal conditions could widen Mannitol’s application scope, further increasing demand.


References

[1] Market Research Future. (2022). Global Mannitol Market Analysis.
[2] IQVIA. (2022). Pharmaceutical Market Trends.
[3] Grand View Research. (2022). Intravenous Solutions Market Size & Trends.

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