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Last Updated: March 30, 2025

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% Drug Patent Profile


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Which patents cover Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12%, and what generic alternatives are available?

Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% 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% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Drug patent expirations by year for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Recent Clinical Trials for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

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SponsorPhase
University Hospital, GenevaPhase 3
Morten Hostrup, PhDN/A
Ecole Polytechnique Fédérale de LausanneEarly Phase 1

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US Patents and Regulatory Information for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
B Braun MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% mannitol INJECTABLE;INJECTION 016080-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

EU/EMA Drug Approvals for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252
Bronchitol 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
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%

Introduction

Mannitol, often combined with dextrose and sodium chloride, is a crucial pharmaceutical product used in various medical applications, including as an osmotic diuretic and for managing increased intracranial pressure. Understanding the market dynamics and financial trajectory of this specific formulation is essential for stakeholders in the pharmaceutical industry.

Clinical Uses and Demand

Mannitol, particularly when combined with dextrose and sodium chloride, is used in several clinical settings:

  • Osmotic Diuretic: Mannitol is used to reduce intracranial pressure and treat cerebral edema. It is also employed to prevent acute renal failure and manage oliguria[2].
  • Hydration and Electrolyte Balance: The addition of dextrose and sodium chloride helps in maintaining hydration and electrolyte balance, which is critical in patient care[1].

The demand for this formulation is steady due to its essential role in critical care and surgical procedures.

Market Players and Competition

The market for mannitol solutions, including those combined with dextrose and sodium chloride, involves several key players:

  • Fresenius Kabi: Known for their mannitol injection products, Fresenius Kabi is a significant player in this market[2].
  • Baxter: Baxter provides various IV solutions, including mannitol and dextrose combinations, and is a major supplier in the healthcare sector[5].
  • Other Manufacturers: Companies like BBraun and Pfizer also offer similar products, contributing to the competitive landscape[4].

Supply Chain and Availability

The availability of mannitol solutions can be affected by several factors:

  • Manufacturing Delays: Shortages can occur due to manufacturing delays, as seen in the case of 5% dextrose injections[4].
  • Increased Demand: Higher demand, especially during peak healthcare needs, can lead to temporary shortages[4].
  • Regulatory Compliance: Ensuring compliance with regulatory standards can sometimes slow down production and distribution.

Financial Trajectory

The financial performance of mannitol solutions, including the 5% mannitol with 5% dextrose in 0.12% sodium chloride formulation, is influenced by several factors:

  • Sales Volume: The consistent demand for these solutions in hospitals and clinical settings drives sales volume.
  • Pricing Strategies: Manufacturers often adjust pricing based on market conditions, competition, and regulatory pressures.
  • Cost of Production: The cost of raw materials, manufacturing, and distribution affects the profitability of these products.

Revenue Trends

The revenue from mannitol solutions has generally been stable due to their essential nature in healthcare. However, fluctuations can occur due to changes in demand, supply chain disruptions, and competitive pricing.

Profit Margins

Profit margins for these products are typically moderate, as the market is competitive and prices are often regulated. Manufacturers must balance profitability with the need to maintain a stable supply and comply with regulatory requirements.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products:

  • FDA Approval: Products must meet strict FDA guidelines for safety, efficacy, and quality[2].
  • Prior Authorization: Some medications, including those used in combination therapies, may require prior authorization, which can impact market access and sales[3].

Market Growth Prospects

The market for mannitol solutions, including the specific formulation of 5% mannitol with 5% dextrose in 0.12% sodium chloride, is expected to grow:

  • Increasing Healthcare Needs: The growing need for critical care and surgical procedures drives the demand for these solutions.
  • Advancements in Healthcare: Advances in medical technology and treatment protocols may increase the use of mannitol and similar solutions.

Challenges and Opportunities

Challenges

  • Supply Chain Disruptions: Manufacturing delays and increased demand can lead to shortages, impacting patient care and financial performance[4].
  • Regulatory Compliance: Ensuring compliance with evolving regulatory standards can be challenging and costly.

Opportunities

  • Innovation: Developing new formulations or delivery methods can provide a competitive edge and expand market share.
  • Global Expansion: Entering new markets, especially in regions with growing healthcare needs, can increase revenue and growth prospects.

Key Takeaways

  • Stable Demand: The demand for mannitol solutions, including the 5% mannitol with 5% dextrose in 0.12% sodium chloride formulation, remains stable due to their critical role in healthcare.
  • Competitive Market: The market is competitive with several key players, influencing pricing and profitability.
  • Regulatory Compliance: Adhering to regulatory standards is crucial for market access and maintaining a stable supply.
  • Growth Prospects: The market is expected to grow driven by increasing healthcare needs and advancements in medical treatments.

FAQs

What is the primary use of mannitol in a clinical setting?

Mannitol is primarily used as an osmotic diuretic to reduce intracranial pressure and treat cerebral edema, as well as to prevent acute renal failure and manage oliguria[2].

Which companies are major players in the market for mannitol solutions?

Key players include Fresenius Kabi, Baxter, BBraun, and Pfizer[2][4][5].

What factors can lead to shortages of mannitol solutions?

Shortages can occur due to manufacturing delays and increased demand[4].

How does the regulatory environment impact the market for mannitol solutions?

The regulatory environment affects market access, pricing, and the need for prior authorization, which can impact sales and profitability[3].

What are the growth prospects for the market of mannitol solutions?

The market is expected to grow due to increasing healthcare needs and advancements in medical treatments[2].

How do supply chain disruptions affect the financial trajectory of mannitol solutions?

Supply chain disruptions, such as manufacturing delays and increased demand, can lead to temporary shortages, impacting patient care and financial performance[4].

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