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Last Updated: December 12, 2025

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. Ten 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
Drug patent expirations by year for MANNITOL 20% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 20% IN PLASTIC CONTAINER

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

SponsorPhase
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2
Laval UniversityNA

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-004 Jan 8, 1990 AP RX 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 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 Container

Last updated: August 5, 2025


Introduction

Mannitol 20% solution administered via plastic containers represents a critical segment within the pharmaceutical industry, primarily utilized as an osmotic diuretic and neuroprotective agent. Its application spans across neurology, nephrology, and ophthalmology, making it a vital component in acute care settings. This analysis dissects the current market landscape, growth drivers, challenges, and financial trends influencing Mannitol 20% in plastic packaging, providing strategic insights for stakeholders.


Market Overview and Segmentation

Global Market Size and Growth Trends

The global demand for Mannitol solutions is experiencing steady growth, driven by increased prevalence of neurological disorders, rising adoption in perioperative care, and expanding manufacturing capacities. As of 2022, the global pharmaceutical-grade Mannitol market was valued at approximately USD 300 million, with an anticipated compound annual growth rate (CAGR) of 6-8% through 2027[1].

The segment focusing on Mannitol 20% in plastic containers is expanding parallelly, fueled by manufacturing innovations that favor plastic over traditional glass packaging due to benefits like reduced weight, cost-efficiency, and enhanced safety.

End-User Segments

  • Hospitals and clinics: The predominant end-users, requiring large-volume, sterile solutions for emergency and routine procedures.
  • Pharmaceutical manufacturers: Utilize Mannitol as an excipient or active ingredient for injectable formulations.
  • Research Institutions: Employ in experimental models and drug development.

Market Drivers

Epidemiological and Clinical Factors

  • Neurological emergencies: Rising cases of elevated intracranial pressure, traumatic brain injuries, and stroke underscore the demand for Mannitol as a first-line osmotic agent[2].
  • Chronic conditions and surgeries: The growth of surgical procedures, especially neurosurgeries and renal treatments, propels consumption of Mannitol solutions.
  • Regulatory approvals and formulations: Clearances for higher concentration formulations in plastic containers foster market expansion.

Technological and Packaging Advancements

  • Plastic container advantages: Plastic (typically polyethylene or polypropylene) offers benefits like impact resistance, drop durability, and ease of transportation, reducing costs and contamination risks.
  • Sterilization and stability: Advances in sterilization techniques (e.g., gamma irradiation) ensure product integrity, further favoring plastic packaging.

Market Expansion in Emerging Economies

Rapid urbanization and healthcare infrastructure development in Asia-Pacific, Latin America, and Africa open new avenues for Mannitol distribution, with sizable investments in hospital capacities and pharmaceutical manufacturing.


Challenges and Constraints

Regulatory and Quality Compliance

  • Stringent regulations around sterile, single-use solutions necessitate rigorous quality assurance, which could increase production costs.
  • Variations in regional standards for single-use plastics could hinder uniformity and scale.

Supply Chain Complexities

  • Dependence on global supply chains for raw materials like sterile grade Mannitol and high-quality plastics could expose the market to disruptions, especially amidst geopolitical tensions or pandemic-related constraints.

Environmental Concerns

  • Growing scrutiny over plastic waste and eco-friendly packaging mandates could challenge market sustainability, incentivizing innovations in biodegradable or recyclable plastics.

Financial Trajectory and Market Forecast

Pricing Trends

  • Prices for Mannitol 20% in plastic containers are influenced by raw material costs, manufacturing efficiencies, and regulatory compliance expenses.
  • The market has observed moderate price stabilization due to increased competition and manufacturing consolidations, with average prices oscillating around USD 2–4 per ml in bulk packaging[3].

Revenue Projections

  • Considering the global market value (~USD 300 million in 2022) and a CAGR of 7%, revenues are projected to reach approximately USD 470–510 million by 2027.
  • The plastic container segment is expected to outpace glass counterparts, with a compounded annual growth rate of 8-10% owing to ongoing packaging innovations.

Profitability Outlook

  • Cost optimization through automation and bulk procurement of raw materials supports healthy profit margins—estimated at 20-25%, contingent upon regional regulatory landscapes and supply chain efficiencies.

Investment Trends

  • Companies are increasing investments in manufacturing capacity, especially in emerging markets, to meet rising demand. Mergers, acquisitions, and strategic partnerships are prevalent for market penetration and technology sharing.

Market Entry Strategies and Opportunities

  • Innovation in packaging: Developing biodegradable, recyclable plastic containers aligned with environmental regulations can differentiate offerings.
  • Geographic expansion: Target emerging markets with burgeoning healthcare infrastructure.
  • Regulatory navigation: Ensuring compliance through early engagement with authorities to streamline approvals.
  • Cost leadership: Leveraging economies of scale and improved manufacturing processes to offer competitive pricing.

Regulatory Landscape

  • The US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional agencies impose strict standards for sterile solution manufacturing.
  • Compliance with Good Manufacturing Practices (GMP) and proper labeling are essential.
  • An evolving regulatory framework for plastics, emphasizing safety and recyclability, influences packaging formulations.

Key Takeaways

  • The global demand for Mannitol 20% solutions in plastic containers is poised for sustained growth driven by clinical demand, technological advancements, and expanding healthcare infrastructure.
  • Plastic packaging's advantages are catalyzing industry transition from traditional glass containers, fostering market expansion.
  • Market growth is tempered by regulatory complexities, environmental considerations, and supply chain vulnerabilities.
  • Strategic investment in packaging innovation, geographic expansion, and regulatory expertise can deliver competitive advantages.
  • Price stability and margin optimization depend on raw material costs, manufacturing efficiencies, and adherence to evolving environmental standards.

FAQs

1. What are the primary healthcare indications for Mannitol 20% solutions?
Mannitol 20% is predominantly used as an osmotic diuretic to reduce intracranial pressure, treat cerebral edema, and manage acute glaucoma. It is also employed in renal protection during surgical procedures.

2. How does plastic container packaging influence Mannitol 20% market dynamics?
Plastic containers enhance safety, reduce weight, and lower transportation costs. Their adoption reflects technological progress, allowing for broader distribution, especially in emerging markets.

3. What are the major regulatory considerations for Mannitol solutions?
Regulatory compliance involves ensuring sterility, stability, and safety standards aligned with GMP, FDA, EMA, and other regional agencies. Packaging materials must meet safety standards concerning plastics.

4. How do environmental concerns impact the Mannitol market?
Environmental impact concerns are prompting industry players to innovate biodegradable or recyclable packaging solutions, influencing materials selection and manufacturing practices.

5. What is the projected financial trajectory for Mannitol 20% in plastic containers?
Projections estimate a CAGR of approximately 7-8%, with market value reaching over USD 470 million by 2027, driven by demand in advanced healthcare settings and expanding geographic markets.


Sources

[1] MarketWatch, "Global Mannitol Market Size, Share & Trends," 2022.
[2] WHO, "Neurological Emergencies and Osmotic Agents," 2021.
[3] Industry Reports, "Pharmaceutical Packaging Market Trends," 2022.

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