Last Updated: May 3, 2026

SORBITOL-MANNITOL IN PLASTIC CONTAINER Drug Patent Profile


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When do Sorbitol-mannitol In Plastic Container patents expire, and what generic alternatives are available?

Sorbitol-mannitol In Plastic Container is a drug marketed by Hospira and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in SORBITOL-MANNITOL IN PLASTIC CONTAINER is mannitol; sorbitol. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mannitol; sorbitol profile page.

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Summary for SORBITOL-MANNITOL IN PLASTIC CONTAINER
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for SORBITOL-MANNITOL 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
Hospira SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 017636-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 018316-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  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

Investment Scenario and Fundamentals Analysis for Sorbitol-Mannitol in Plastic Containers

Last updated: March 3, 2026

What is the Market for Sorbitol-Mannitol in Plastic Containers?

The sorbitol-mannitol combination is used primarily as osmotic laxatives, bulk-forming agents, or carriers in pharmaceutical and food industries. The packaging medium—plastic containers—supplies stability, ease of handling, and compatibility with sensitive compounds.

Market Size and Growth

  • Global pharmaceutical excipients market: Estimated at $10.7 billion in 2022, expected to expand at a CAGR of 6.1% from 2023 to 2030 ([1]).
  • Sorbitol and Mannitol segments: Constitute approximately 8-10% of the excipients market, with projected growth driven by demand in generics, OTC products, and specialized formulations.
  • Plastic packaging segment: Growing at a CAGR of 4.5% (2022-2030), expected to reach $350 billion by 2030 ([2]).

Demand Drivers

  • Increase in chronic diseases: Diabetes and gastrointestinal disorders elevate demand for oral pharmaceuticals.
  • Growth of OTC medicines: Consumers prefer convenient packaging—plastic containers are cost-effective and durable.
  • Regulatory shifts: Emphasis on patient-friendly, tamper-proof packaging favors plastic containers.

Regional Dynamics

Region Market Size (2022) CAGR (2023-2030) Key Drivers
North America $3.2 billion 6.0% Aging population, regulation
Europe $2.4 billion 5.8% R&D investment, demand for OTCs
Asia-Pacific $2.0 billion 7.0% Manufacturing growth, rising health awareness

Fundamentals of Sorbitol and Mannitol in Pharmaceutical Applications

Chemical and Physical Properties

  • Sorbitol: A sugar alcohol with sweetening properties, hygroscopic nature, and compatibility with oral formulations.
  • Mannitol: A sugar alcohol with diuretic and cryoprotectant properties, stable under various pH conditions.

Production and Supply Dynamics

  • Major suppliers: Cargill, Roquette, and Sigma-Aldrich produce large quantities of pharmaceutical-grade sorbitol and mannitol.
  • Manufacturing cost: Approximately $1.50-$2.50 per kg, subject to scale, purity, and regional input costs.
  • Supply chain: Concentrated in China, Europe, and North America. Disruptions (e.g., geopolitical, logistics) impact pricing and availability.

Regulatory Environment

  • Good Manufacturing Practices (GMP): Mandatory for pharmaceutical-grade excipients.
  • FDA and EMA approvals: Confirm compatibility and safety for specific formulations.
  • Environmental regulations: Focused on reduction of plastic waste, influencing packaging choices.

Packaging Material Compatibility

  • Plastic containers—typically high-density polyethylene (HDPE) or polypropylene (PP)—are inert, moisture-resistant, and protect against contamination.
  • Concerns about leaching or interaction are minimal with modern plastics, but stability testing is necessary for sensitive formulations.

Investment Considerations

Market Entry and Competitors

  • Barriers to entry: High regulatory standards, established supplier dominance.
  • Key competitors: Cargill, Roquette, Merck Millipore, and local producers.
  • Differentiation: Packaging innovation, including tamper-evident and child-resistant plastic containers.

Cost and Pricing Dynamics

  • Raw material costs: Sensitive to feedstock prices, geopolitical factors.
  • Pricing trends: Slight downward pressure due to competitive sourcing and economies of scale.
  • Profit margins: Approximately 15-20% for manufacturers, with potential for higher margins through premium packaging and formulations.

Regulatory and Sustainability Trends

  • Regulatory compliance: Essential for market access; non-compliance leads to product recalls or bans.
  • Environmental concerns: Push towards biodegradable plastics and sustainable sourcing.

Risks

  • Supply chain disruptions: Fluctuations in raw material costs or geopolitical issues.
  • Regulatory delays: Impacting approval timelines for new product formulations.
  • Market saturation: Intense competition and commoditization of excipients.

Strategic Outlook

  • Investment in innovation: Developing new packaging solutions that improve stability and compliance.
  • Market expansion: Target emerging markets with growing pharmaceutical manufacturing.
  • Partnerships: Collaborations with formulators and global packaging firms enhance market penetration.

Key Financial Indicators and Forecasts

Indicator 2022 2023-2030 Forecast Notes
Market Value (pharma excipients) $10.7 billion CAGR 6.1% Growth driven by OTC, generics, and novel formulations
Plastic packaging market $250 billion CAGR 4.5% Includes pharmaceutical-specific applications
Raw material costs (sorbitol/mannitol) $1.50-$2.50/kg - Sensitive to feedstock prices and supply chains
Profit margins 15-20% Stable or slightly declining Price competition pressure

Key Takeaways

  • The combination of sorbitol and mannitol in plastic containers has a solid market basis, concentrated in OTC and generic pharmaceuticals.
  • Growth is driven by rising demand for oral drugs, regulatory compliance, and packaging innovations.
  • Proprietary formulations and superior packaging can provide differentiation, but regulatory hurdles and raw material costs pose threats.
  • Market expansion in Asia-Pacific and emerging economies offers significant growth potential.

FAQs

Q1: What are the primary applications of sorbitol-mannitol in pharmaceuticals?
A1: Used as excipients in laxatives, bulking agents, and carriers in oral dosage forms, especially in formulations requiring stability and moisture resistance.

Q2: How does packaging impact the market for these excipients?
A2: Plastic containers offer stability, ease of use, and cost-efficiency, critical for maintaining product integrity and meeting regulatory standards.

Q3: What are the key risks for investing in this market segment?
A3: Raw material price volatility, supply chain disruptions, regulatory delays, and market saturation.

Q4: Which regions represent high-growth opportunities?
A4: Asia-Pacific, Latin America, and Eastern Europe, driven by expanding pharmaceutical manufacturing and healthcare infrastructure.

Q5: How does sustainability influence future market developments?
A5: Increasing demand for biodegradable plastics and environmentally sustainable sourcing impacts packaging choices and investment strategies.


References

[1] Grand View Research. (2023). Pharmaceutical Excipients Market Size, Share & Trends Analysis Report.
[2] Fortune Business Insights. (2022). Plastic Packaging Market Size, Share & Industry Analysis.

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