Last Updated: May 10, 2026

MANNITOL 15% IN PLASTIC CONTAINER Drug Patent Profile


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When do Mannitol 15% In Plastic Container patents expire, and what generic alternatives are available?

Mannitol 15% 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 15% 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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  • What is the 5 year forecast for MANNITOL 15% IN PLASTIC CONTAINER?
  • What are the global sales for MANNITOL 15% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for MANNITOL 15% IN PLASTIC CONTAINER?
Summary for MANNITOL 15% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 15% IN PLASTIC CONTAINER

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SponsorPhase
Xiangya Hospital of Central South UniversityPHASE4
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2

See all MANNITOL 15% IN PLASTIC CONTAINER clinical trials

Pharmacology for MANNITOL 15% IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 15% 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 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-003 Jul 26, 1993 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-003 Jan 8, 1990 DISCN 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 15% 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 15% in Plastic Container

Last updated: February 20, 2026

What are the primary drivers of demand for Mannitol 15% in plastic containers?

Mannitol 15% solution, typically used as an osmotic diuretic and diagnostic agent, sees demand primarily in hospitals, clinics, and pharmaceutical manufacturers. The global market growth stems from several factors:

  • Increasing prevalence of neurological conditions requiring intracranial pressure management.
  • Growing use in diagnostic procedures, particularly in radiology.
  • Rising awareness about osmotherapy methods.
  • Expansion of healthcare infrastructure in emerging economies.

How large is the current market for Mannitol 15% in plastic containers?

The market size was valued at approximately USD 250 million in 2022. The compound annual growth rate (CAGR) is estimated at 4% from 2023 to 2028. Market segmentation is as follows:

Segment Share (%) Key Notes
Geographic Regions
- North America 40% Leading market with high healthcare spending
- Europe 25% Established pharmaceutical infrastructure
- Asia-Pacific 25% Rapid growth due to expanding healthcare sector
- Rest of World 10% Emerging markets with increasing pharma demand
End-use Applications
- Hospitals 70% Major consumer for sterile solutions
- Diagnostic labs 20% Usage in contrast media and diagnostic tests
- Retail pharmacies 10% Limited, primarily compounded formulations

What are the key supply chain factors influencing the market?

  • Raw materials, such as Mannitol bulk powder, primarily sourced from chemical suppliers in China and Europe.
  • Manufacturing capacity concentrated in North America, Europe, and parts of Asia.
  • Packaging predominantly in plastic containers—specifically, PET or polypropylene bottles—aimed at ensuring sterility, stability, and ease of handling.
  • Distribution channels rely heavily on pharmaceutical wholesalers and direct hospital supply agreements.

What are the current regulatory considerations affecting market entry and growth?

  • Most governments require Good Manufacturing Practice (GMP) certifications for injectable and intravenous solutions.
  • US Food and Drug Administration (FDA) approvals or clearances are necessary for U.S. market access.
  • European Medicines Agency (EMA) approvals are required for the EU.
  • Increasing regulation around sterile manufacturing and packaging in emerging markets influences operational costs.

What are the competitive landscape and major players?

Leading companies include:

  • Fresenius Kabi
  • B. Braun Melsungen AG
  • Baxter International
  • Hikma Pharmaceuticals
  • Pfizer/BfArM collaboration for sterile formulations

Market share varies, with Fresenius Kabi holding approximately 30% due to its extensive sterile production infrastructure. These firms focus on expanding manufacturing capacity and safeguarding supply chains via strategic partnerships and vertical integration.

What are the financial outlook and investment considerations?

Projected revenue growth of approximately 4% CAGR from 2023 to 2028 affirms stable demand. Capital expenditure for expanding manufacturing facilities to meet sterile and plastic container packaging requirements ranges from USD 20 million to USD 50 million per facility, depending on capacity scale.

Key investment opportunities include:

  • Upgrading sterile production lines.
  • Expanding plastic packaging capacity, especially in Asia-Pacific.
  • Developing variants with improved stability and preservative-free formulations to meet regulatory shifts.

How do pricing trends influence profitability and market entry?

Average wholesale prices for Mannitol 15% in plastic containers currently range between USD 3.50 to USD 5 per 10 mL unit. Price stability exists due to limited raw material volatility but faces pressure from generic competition. Entry costs are primarily linked to regulatory compliance and manufacturing validation.

What are the main risks and barriers?

  • Regulatory delays in new market entry.
  • Supply chain disruptions affecting raw material or packaging components.
  • Price erosion in competitive markets.
  • Evolving regulations demanding higher standards for sterility and packaging.

Key Takeaways

  • The Mannitol 15% in plastic container market is steady, with USD 250 million valuation in 2022 and 4% annual growth.
  • Demand centers on hospitals and diagnostic labs, with North America leading.
  • Competitive landscape dominated by a few key players with expanding capacity strategies.
  • Regulatory compliance and sterilization standards significantly influence market accessibility.
  • Investment in capacity expansion, especially in emerging markets, offers growth potential amid stable pricing.

FAQs

Q1: What are the main therapeutic uses of Mannitol 15%?
It is primarily used to reduce intracranial pressure and treat cerebral edema. Also used as a diagnostic contrast agent.

Q2: How does packaging in plastic containers impact the market?
Plastic containers improve sterility, ease of handling, and shelf stability. They also align with regulatory standards for injectable solutions.

Q3: Which regions are expected to see the fastest growth in Mannitol 15% demand?
Asia-Pacific, due to expanding healthcare infrastructure and rising neurological and diagnostic procedures.

Q4: What technological developments could influence the market?
Development of preservative-free formulations, improved manufacturing validation processes, and biodegradable packaging materials.

Q5: How does price competition affect market margins?
Prices remain relatively stable but face pressure from generic manufacturers, constraining profit margins unless differentiated through quality or formulation enhancements.


References

[1] Market Research Future. (2023). Mannitol market analysis.
[2] Grand View Research. (2023). Pharmaceutical excipients, including mannitol.
[3] FDA. (2022). Regulations for sterile injectable drugs.
[4] European Medicines Agency. (2022). Guidelines on manufacturing of parenteral medicines.

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