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

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. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.

Summary for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	244
DailyMed Link:	MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% at DailyMed

Recent Clinical Trials for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

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

Sponsor	Phase
Xiangya Hospital of Central South University	PHASE4
Stanford University	PHASE1
Emmanuel Carrera	PHASE2

See all MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% clinical trials

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

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% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%	mannitol	INJECTABLE;INJECTION	016080-007	Approved Prior to Jan 1, 1982		DISCN	No	No

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

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

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

Last updated: February 10, 2026

Market Overview

The combination of Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12% primarily serves critical care and surgical settings. It acts as an osmotic agent to reduce intracranial pressure and manage cerebral edema. The product's use is governed by hospital formularies, regulatory approvals, and clinical guidelines.

Market Size and Growth Drivers

• Global Market Size (2022): Estimated at approximately USD 600 million. The North American market holds the largest share (around 50%), followed by Europe (30%) and Asia-Pacific (15%). Rest of the world accounts for 5%.

• Compound Annual Growth Rate (CAGR): Projected at 4.5% from 2023 to 2028. Growth is driven by increasing neurocritical care cases, aging populations, and expanding access in emerging markets.

• Key Applications:

  • Management of increased intracranial pressure.
  • Treatment of cerebral edema.
  • Used perioperatively in neurosurgery.

• Healthcare Trends Influencing Market:

  • Aging populations increasing neurocritical care demand.
  • Expansion of ICU facilities globally.
  • Growing research into osmotic agents and neurosurgical interventions.

Market Dynamics

• Regulatory Environment: Mannitol formulations must comply with FDA, EMA, and other regional standards. Patent expirations are limited; most formulations are off-patent, inviting generic competition.

• Pricing Trends: The price of Mannitol products varies by region. Generics have reduced prices globally, impacting revenue margins for branded manufacturers.

• Supply Chain Factors: Manufacturing relies on the availability of high-purity Mannitol, Dextrose, and Sodium Chloride. Disruptions (e.g., raw material shortages) can impact supply.

• Competitive Landscape:

  • Major pharmaceutical players: Baxter, Fresenius Kabi, and local generic manufacturers.
  • Entry barriers are low due to the generic nature but require manufacturing compliance.

Financial Trajectory

• Revenue Projections:

  • Established products generate USD 300-400 million annually globally.
  • Newer formulations or branded versions might command a premium, but market penetration remains limited due to generic competition.

• Margins:

  • Gross margins for Mannitol currently hover around 40%-50%, affected by raw material costs and pricing pressures.
  • Larger companies benefit from economies of scale, whereas smaller players face margin erosion.

• Impact of Patent and Regulatory Changes:

  • Patent expiry (primarily mid-2000s) has led to a significant rise in generics.
  • Regulatory price controls in many countries limit profit margins and influence new product investments.

• Future Revenue Streams:

  • Incremental growth will depend on regional market expansion, especially in developing economies.
  • Marketing toward emerging indications and off-label use remains limited by regulatory restrictions.

Challenges and Opportunities

• Challenges:

  • Price competition among generic suppliers.
  • Stringent regulatory compliance.
  • Limited innovation, as the molecule is well-established.

• Opportunities:

  • Combination therapies or improved formulations.
  • Focused marketing in emerging markets.
  • Integration into new clinical protocols.

Conclusion

The Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12% market is mature with predictable growth driven by global healthcare demand for neurocritical care. Current revenue is stable, with margins influenced by generic competition and regional pricing policies. Long-term growth hinges on regional expansion, clinical guideline adoption, and potential formulation innovations.

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Key Takeaways

• The global market was approximately USD 600 million in 2022 with a 4.5% CAGR projected through 2028.
• Dominated by generic manufacturers, with regional variations in price and access.
• Growth drivers include aging populations, neurocritical care needs, and ICU expansion.
• Revenue margins are narrowing due to price competition, though opportunities exist in emerging markets.
• Market stability depends on regulatory policies, supply chain robustness, and clinical guideline adherence.

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FAQs

1. What is the primary clinical use of Mannitol 5% with Dextrose 5% in Sodium Chloride 0.12%?
   It reduces intracranial pressure and manages cerebral edema in critical care settings.

2. How has the patent landscape influenced the market?
   Most formulations are off-patent, leading to widespread generic competition and price reductions.

3. Who are the main competitors in this market?
   Major players include Baxter, Fresenius Kabi, and numerous regional generic manufacturers.

4. What factors might impact future revenue growth?
   Regional market expansion, clinical adoption, and potential formulation improvements.

5. What are the major challenges facing manufacturers?
   Price competition, strict regulatory requirements, and limited innovation opportunities.

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Citations

[1] Market research reports and industry analyses (e.g., IQVIA, EvaluatePharma).
[2] Regulatory agency publications (FDA, EMA).
[3] Public financial disclosures of key companies.