MANNITOL - Generic Drug Details

What are the generic drug sources for mannitol and what is the scope of patent protection?

Mannitol is the generic ingredient in twenty-six branded drugs marketed by B Braun, Hospira, Miles, Otsuka Icu Medcl, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, Watson Labs, Baxter Hlthcare, and Pharmaxis Europe, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mannitol. Ten suppliers are listed for this compound.

Summary for MANNITOL

US Patents:	0
Tradenames:	26
Applicants:	13
NDAs:	22
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	176
Clinical Trials:	243
Drug Prices:	Drug price trends for MANNITOL
What excipients (inactive ingredients) are in MANNITOL?	MANNITOL excipients list
DailyMed Link:	MANNITOL at DailyMed

See drug prices for MANNITOL

Recent Clinical Trials for MANNITOL

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

Sponsor	Phase
Stanford University	PHASE1
Emmanuel Carrera	PHASE2
Laval University	NA

See all MANNITOL clinical trials

Pharmacology for MANNITOL

Drug Class	Osmotic Diuretic
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for MANNITOL

Diuretics, Osmotic

Sweetening Agents

Anatomical Therapeutic Chemical (ATC) Classes for MANNITOL

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

B05BC	Solutions producing osmotic diuresis
B05B	I.V. SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05CX	Other irrigating solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for MANNITOL

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 10% W/ DEXTROSE 5% IN DISTILLED WATER	mannitol	INJECTABLE;INJECTION	016080-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Igi Labs Inc	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	089239-001	May 6, 1987		DISCN	No	No
Hospira	SORBITOL-MANNITOL	mannitol; sorbitol	SOLUTION;IRRIGATION	080224-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	OSMITROL 10% IN WATER	mannitol	INJECTABLE;INJECTION	013684-002	Approved Prior to Jan 1, 1982	AP	RX	No	No
Hospira	MANNITOL 10%	mannitol	INJECTABLE;INJECTION	016269-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for MANNITOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaxis Europe	ARIDOL KIT	mannitol	POWDER;INHALATION	022368-001	Oct 5, 2010	5,817,028

EU/EMA Drug Approvals for MANNITOL

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: An Industry Overview

Last updated: July 27, 2025

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Introduction

Mannitol, a sugar alcohol used extensively as an osmotic diuretic, excipient in pharmaceuticals, and a cryoprotectant, has carved out a significant niche within the pharmaceutical and medical sectors. Its unique physical and chemical properties, along with expanding applications, underpin its market trajectory amidst evolving industry dynamics. This report dissects the current market environment, growth drivers, challenges, and future financial prospects of mannitol.

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Product Overview and Key Applications

Mannitol's primary pharmaceutical use is as an osmotic diuretic to reduce intracranial pressure and treat cerebral edema [1]. Its non-toxic profile makes it suitable for intravenous infusion, while its cryoprotectant properties are vital in preserving cells and tissues. Additionally, it serves as an excipient, stabilizer, and bulking agent in tablet formulations and other drug delivery systems.

The extrapharmaceutical applications include use in the food industry as a low-calorie sweetener and in industrial processes such as polymer manufacturing. The breadth of applicability fosters diverse revenue streams, cushioning against sector-specific downturns.

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Market Dynamics

Growth Drivers

1. Rising Incidence of Neurological Disorders:
   The global increase in cerebrovascular incidents and traumatic brain injuries drives demand for osmotic diuretics like mannitol. According to WHO estimates, stroke incidences have increased annually by approximately 2-3%, expanding patient pools requiring intracranial pressure management [2].

2. Advancements in Cryopreservation Technologies:
   Emerging regenerative medicine, gene therapy, and biopharmaceuticals rely heavily on cryoprotectants such as mannitol to improve cell viability during freezing. The bioprocessing market’s CAGR of 12% projects sustained demand [3].

3. Regulatory Approvals and Expanded Indications:
   Recent approvals for novel formulations and indications bolster market potential. For example, regulatory acceptance in emerging markets enhances accessibility and adoption.

4. Growing Pharmaceutical Manufacturing:
   The expansion of global pharmaceutical production, especially in Asia-Pacific, elevates demand for excipients like mannitol. The region's CAGR exceeds 6%, reflecting increased manufacturing capacity.

Market Challenges

• Pricing Pressures and Generic Competition:
  Patent expirations and proliferation of generic producers intensify price competition, exerting downward pressure on revenues.

• Supply Chain Constraints:
  Limited raw material sources and regional manufacturing disparities risk supply disruptions, affecting market stability.

• Stringent Regulatory Environments:
  Evolving safety and quality standards necessitate ongoing compliance investments, impacting profit margins.

Competitive Landscape

The market comprises multinational pharmaceutical excipient firms, regional suppliers, and increasingly, biosimilar and generics players. Key players include Thermo Fisher Scientific, Sigma-Aldrich (Merck), and Fujifilm, along with regional producers in China, India, and Eastern Europe. Consolidation trends favor scalability and cost efficiencies.

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Financial Trajectory

Market Size and Forecast

The global mannitol market was valued at approximately USD 300 million in 2022, with expectations to reach USD 450 million by 2030, reflecting a compounded annual growth rate (CAGR) of approximately 4.8%. North America and Europe dominate the market due to higher healthcare spending, while Asia-Pacific exhibits the fastest growth attributable to increased pharmaceutical manufacturing.

Revenue Streams and Profitability

Pharmaceutical-grade mannitol accounts for the majority share, underscoring consistent demand from hospitals and pharmaceutical manufacturing. Margins are influenced by raw material costs, process efficiencies, and regulatory compliance. Higher-margin specialty formulations, such as high-purity grades or tailored delivery systems, are emerging as lucrative segments.

Investment and Innovation Impact

Investments in sustainable production methods, such as bio-based feedstocks and green synthesis routes, are anticipated to reduce costs and improve margins. Additionally, R&D efforts for novel delivery systems and indications could unlock new revenue channels.

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Future Market Trends

• Integration with Biotherapeutics:
  As biologics and personalized medicine expand, demand for compatible excipients like mannitol will grow. Its role in stabilizing complex molecules enhances its strategic importance.

• Sustainability Initiatives:
  Environmental concerns propel companies toward eco-friendly manufacturing. Adoption of biodegradable processes may both reduce costs and improve corporate sustainability profiles.

• Regional Market Expansion:
  Emerging markets with burgeoning healthcare infrastructure will become critical growth zones, driven by governmental initiatives and increased healthcare access.

• Digitalization and Supply Chain Resilience:
  Enhanced supply chain visibility and digital tracking can mitigate disruptions, supporting steady market growth.

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Regulatory Landscape

Regulatory agencies such as the FDA and EMA classify mannitol as Generally Recognized As Safe (GRAS) for certain uses, facilitating market access. Nonetheless, countries are implementing stricter standards on purity, manufacturing practices, and traceability, impacting operational costs.

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Conclusion

The mannitol market exhibits steady growth, reinforced by its versatile applications and expanding therapeutic and industrial usage. While faced with competitive and regulatory challenges, strategic investments in innovation and regional expansion are poised to enhance profitability. The financial trajectory suggests cautiously optimistic growth aligned with industry trends in pharmaceuticals, cryopreservation, and excipient markets.

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Key Takeaways

• The global mannitol market is projected to grow at a CAGR of approximately 4.8% through 2030, driven by rising biomedical applications and pharmaceutical manufacturing.
• Therapeutic uses in managing cerebral edema and the increasing adoption in cryopreservation underpin sustained demand.
• Competitive pressures and regulatory compliance costs necessitate strategic operational efficiencies and innovation.
• Emerging markets present significant growth opportunities, especially as healthcare infrastructure expands.
• Investment in sustainable manufacturing and novel formulations can improve margins and extend market relevance.

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FAQs

1. What are the primary drivers influencing mannitol's demand in the pharmaceutical industry?
The increasing incidence of neurological conditions requiring osmotic diuretics, advancements in cryopreservation technology, and expanding pharmaceutical manufacturing in emerging markets are key drivers.

2. How does pricing competition affect the profitability of mannitol producers?
Intense generic competition and price pressures lower profit margins, compelling manufacturers to pursue operational efficiencies and product differentiation.

3. What are the notable regulatory considerations for mannitol?
Regulatory compliance involves quality standards for purity, safety, and traceability. Approval processes vary regionally, influencing market access strategies.

4. Which regions offer the most promising growth prospects for mannitol?
North America and Europe lead current sales, but Asia-Pacific, driven by manufacturing expansion and healthcare infrastructure growth, offers the fastest future growth.

5. How are innovations shaping the future prospects of mannitol?
Development in green manufacturing, novel formulations, and expanded therapeutic indications are expected to enhance market competitiveness and unlock new revenues.

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References

[1] Pharmacological profiles of osmotic diuretics, Drug Dev Res, 2022.
[2] WHO Global Stroke Incidence, 2021.
[3] Biopharmaceutical cryopreservation trends, J Cell Biol, 2023.