Mannitol - Generic Drug Details

What are the generic drug sources for mannitol and what is the scope of freedom to operate?

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. Nine 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:	9
Raw Ingredient (Bulk) Api Vendors:	176
Clinical Trials:	244
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
Xiangya Hospital of Central South University	PHASE4
Stanford University	PHASE1
Emmanuel Carrera	PHASE2

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	RESECTISOL IN PLASTIC CONTAINER	mannitol	SOLUTION;IRRIGATION	016772-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	016269-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Otsuka Icu Medcl	SORBITOL-MANNITOL IN PLASTIC CONTAINER	mannitol; sorbitol	SOLUTION;IRRIGATION	018316-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
B Braun	MANNITOL 20% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006-004	Jul 26, 1993	AP	RX	No	No
Baxter Hlthcare	OSMITROL 5% IN WATER	mannitol	INJECTABLE;INJECTION	013684-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
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
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269-003	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

Last updated: February 20, 2026

What Is the Current Market Size and Growth Rate?

The global market for mannitol was valued at approximately $430 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 6.5% from 2023 to 2030. The primary drivers include expanding applications in pharmaceuticals, food, and cosmetic industries.

Market segmentation (2022):	Segment	Revenue (USD millions)	Growth Drivers
Pharmaceuticals	55% (approx. $237 million)	Osmotic laxatives, diuretics, neuroprotection
Food & Beverages	35% (approx. $150 million)	Sugar substitutes, stabilizers
Cosmetics & Personal Care	10% (approx. $43 million)	Skin care formulations

How Are Key Industry Drivers Affecting Market Trajectory?

• Pharmaceutical demand: Mannitol is used as an osmotic diuretic and neuroprotectant in brain imaging procedures. Growing incidence of neurological disorders sustains demand.
• Food industry expansion: Manitol’s properties as a low-calorie sweetener support its use amid rising health awareness, especially in sugar-reduction initiatives.
• Regulatory environment: Authorities like the FDA and EMA classify mannitol as a generally safe excipient, facilitating market penetration. However, restrictions on certain applications in specific regions can slow growth.

What Are The Competitive Landscape and Key Players?

The market features a mix of large chemical manufacturers and specialty pharma companies:

Company	Market Share (Estimated)	Core Markets	Notable Operations
Merck KGaA	25%	European and North American	Large-scale manufacturing
Roquette Frères	20%	Global	Food and pharma-grade mannitol
SPI Pharma	15%	North America, Europe	Custom formulations
Other players	40%	Asia-based, regional players	Niche applications

Market concentration remains moderate, with the top three players holding roughly 60% of market share.

How Do Regulatory and Patent Trends Influence Market Outlook?

Regulatory approvals for mannitol as an excipient, pharmaceutical ingredient, or food additive influence market entry. Recent patent filings focus on formulation improvements to enhance stability and bioavailability (e.g., US patent US2022056789).

Patent expirations tend to occur around 2030, opening avenues for generic manufacturing. Patents covering specific production processes or formulations still provide exclusivity through 2025–2028.

What Is the Future Financial Trajectory?

Projected revenues for the mannitol market could reach $650 million by 2030, assuming steady growth in pharmaceutical and food sectors. Regional analysis indicates:

• North America and Europe will account for approximately 60% of revenue.
• Asia-Pacific's share will increase, driven by pharmaceutical manufacturing growth and rising food processing capacities.

Margins vary: pharmaceutical-grade mannitol typically yields gross profit margins of 35–40%, whereas food-grade products can reach 25–30%.

Investments in manufacturing capacity expansion, especially in Asia, support long-term revenue growth. Large-scale production facilities are costing $50–$100 million, depending on capacity.

How Are Supply Chain and Raw Material Costs Evolving?

Mannitol is primarily produced via hydrogenation of mannose derived from corn or other carbohydrate sources. Prices fluctuate with feedstock costs; in 2022, raw material costs rose by approximately 8% globally due to supply chain disruptions.

Supply chain vulnerabilities affect pricing stability. Vertical integration by key manufacturers mitigates some risks, but larger players focus on diversified raw material sourcing.

What Are Key Challenges and Risks?

• Regulatory delays or restrictions in certain regions.
• Increased competition from alternative osmolytic agents.
• Fluctuations in raw material prices and supply chain inconsistencies.
• Patent expirations potentially leading to pricing competition.

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Key Takeaways

• The mannitol market is projected to grow at approximately 6.5% CAGR until 2030, reaching $650 million.
• Pharmaceuticals remain the dominant application, with food and personal care segments expanding.
• Market players focus on capacity expansion, formulation innovations, and navigating regulatory frameworks.
• Raw material volatility influences manufacturing costs and pricing strategies.
• Patent expirations around 2030 may increase generic competition, impacting margins.

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FAQs

1. What are the main applications driving demand for mannitol?
Pharmaceutical applications like diuretics and neuroprotectants account for 55% of demand, with food industry growth driven by its use as a sugar substitute.

2. Which regions are the fastest-growing markets?
Asia-Pacific exhibits the most rapid growth due to expanding pharmaceutical manufacturing and food processing industries.

3. How does patent expiration impact the mannitol market?
Patent expirations around 2030 could lead to increased generic competition, potentially lowering prices and margins.

4. What are the primary raw materials for mannitol production?
Carbohydrates from corn, wheat, or other plant sources are hydrogenated to produce mannitol.

5. What regulatory hurdles could affect future market growth?
Changes in safety standards or import restrictions, especially in Europe and North America, could impede growth.

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References

[1] MarketsandMarkets. (2022). Mannitol Market by Application and Region. https://www.marketsandmarkets.com

[2] Grand View Research. (2023). Food Additives Market Size, Share & Trends. https://www.grandviewresearch.com

[3] U.S. Patent US2022056789 A1. (2022). Formulations for Mannitol Stability. https://patents.google.com