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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, Icu Medical Inc, 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:	225
Patent Applications:	7,113
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
University Hospital, Geneva	Phase 3
Morten Hostrup, PhD	N/A
University Hospital Inselspital, Berne	Early Phase 1

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
Hospira	MANNITOL 20%	mannitol	INJECTABLE;INJECTION	016269-004	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	MANNITOL 20%	mannitol	INJECTABLE;INJECTION	016080-004	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	MANNITOL 10% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006-002	Jul 26, 1993	AP	RX	No	No
Hospira	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	016269-005	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/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

Mannitol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mannitol

Introduction to Mannitol

Mannitol, a sugar alcohol, is widely used in various industries, including pharmaceuticals, food, and beverages. Its unique properties, such as high water solubility, low moldability, and excellent wetting properties, make it a preferred choice over other sugar alcohols.

Current Market Size and Forecast

As of 2022, the global mannitol market was estimated to be around USD 418.65 million[1][4].

• By 2023, the market is expected to reach approximately USD 448.38 million.
• The market is projected to grow significantly, reaching USD 890.31 million by 2033, with a Compound Annual Growth Rate (CAGR) of 7.1% from 2023 to 2033[1].

Growth Drivers

Increasing Population and Lifestyle Changes

The growing global population and evolving lifestyles are key drivers of the mannitol market. As people become more health-conscious, the demand for low-calorie and non-cariogenic sweeteners like mannitol increases[1][4].

Rising Incidence of Diabetes

The increasing incidence of diabetes globally is a significant factor. Mannitol does not cause a significant increase in blood glucose levels, making it an attractive option for diabetic patients. Countries like Brazil, with high rates of obesity and type 2 diabetes, are driving this demand[1].

Consumer Health Consciousness

Consumer awareness of health issues is on the rise, leading to increased demand for functional and convenient foods. In the UK, for example, the demand for healthy and immune-boosting products has accelerated due to COVID-19, boosting the mannitol market[1].

Pharmaceutical Applications

Mannitol is used as an excipient in pharmaceutical products and for treating kidney, brain, and heart problems. Its use as a bulking agent in tableting applications further supports market growth[1][4].

Regional Market Dynamics

Asia Pacific

The Asia Pacific region, particularly China and India, dominates the global mannitol market. China is expected to account for over 52.9% of the Asia Pacific market in 2023 and is the world's leading producer of sugar alternatives. India, with its high prevalence of diabetes, obesity, and heart disorders, also drives significant demand[1][4].

Europe

Europe is predicted to be the fastest-growing region due to expanding R&D activities and rising demand from various end-user industries. The UK mannitol market, for instance, is expected to be valued at USD 12.4 million in 2023[1][4].

Latin America

Brazil is among the fastest-growing countries in Latin America, with high rates of obesity and type 2 diabetes. The government's efforts to limit sugar consumption have made mannitol a popular sugar substitute, contributing to the market's growth[1].

Market Segments

Food and Beverage Sector

The food and beverage sector is a major driver of mannitol sales. Its application as a sweetener in baked goods, confectionery items, and mint-based sweets and gums is increasing due to its cooling effect and low-calorie properties[1][4].

Pharmaceutical Sector

Mannitol's use in pharmaceuticals, particularly as an excipient and for treating various health conditions, continues to support market growth. The API mannitol sales market, for example, was valued at USD 185 million in 2023 and is projected to reach approximately USD 300 million by 2032[5].

Technological Advances

Recent technological advances in synthesizing mannitol using less expensive raw materials, such as production utilizing lactic acid bacteria, are expected to boost yield while maintaining high purity quality. This innovation is likely to further support market growth[4].

Challenges and Opportunities

Challenges

Despite the positive growth trajectory, the mannitol market faces challenges such as competition from other sugar substitutes and fluctuations in raw material prices. However, these challenges also present opportunities for innovation and cost reduction.

Opportunities

The increasing demand for natural and organic food items and the growing awareness of health issues offer significant opportunities for the mannitol market. Capitalizing on these trends by introducing natural food ingredients and expanding into new markets can drive further growth[1][4].

Key Players

The mannitol market is dominated by key players such as Roquette, Ingredion, and Cargill. These companies are investing in R&D to improve production processes and expand their product offerings to meet the growing demand[2].

Volume Sales and Shipments

Volume sales of mannitol are expected to rise at a rate of 5.62% in 2023, with shipments reaching 66,998 MT in the same year. This positive growth trajectory is expected to continue over the forecast period[1].

Consumer Trends

The demand for functional foods and low-calorie sweeteners is on the rise. Consumers are increasingly looking for products that are healthy, convenient, and taste good. Mannitol's use in functional and convenient foods elevates its market growth, especially in regions like the UK and Brazil[1].

Statistical Highlights

• Market Value (2022): USD 418.65 million[1][4]
• Projected Market Value (2033): USD 890.31 million[1]
• CAGR (2023-2033): 7.1%[1]
• Volume Sales Growth Rate (2023): 5.62%[1]
• Shipments (2023): 66,998 MT[1]

Conclusion

The mannitol market is poised for significant growth driven by increasing health consciousness, the rising incidence of diabetes, and technological advances. As consumers continue to seek healthier alternatives, the demand for mannitol is expected to rise, making it a lucrative market for investors and manufacturers.

Key Takeaways

• The global mannitol market is expected to reach USD 890.31 million by 2033.
• The market is driven by increasing health consciousness and the rising incidence of diabetes.
• Asia Pacific, particularly China and India, dominates the global market.
• Technological advances in production are expected to boost market growth.
• Key players like Roquette, Ingredion, and Cargill are leading the market.

FAQs

Q: What is the current market size of the global mannitol market? A: As of 2022, the global mannitol market was estimated to be around USD 418.65 million[1][4].

Q: What is the projected CAGR of the mannitol market from 2023 to 2033? A: The mannitol market is projected to grow at a CAGR of 7.1% from 2023 to 2033[1].

Q: Which region dominates the global mannitol market? A: The Asia Pacific region, particularly China and India, dominates the global mannitol market[1][4].

Q: What are the primary applications of mannitol? A: Mannitol is used as an excipient in pharmaceuticals, as a bulking agent in tableting, and as a sweetener in the food and beverage sector[1][4].

Q: How is the rising incidence of diabetes impacting the mannitol market? A: The rising incidence of diabetes is driving the demand for low-calorie sweeteners like mannitol, which does not cause a significant increase in blood glucose levels[1].