MANNITOL 20% Drug Patent Profile

Which patents cover Mannitol 20%, and what generic alternatives are available?

Mannitol 20% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in six NDAs.

The generic ingredient in MANNITOL 20% 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.

Summary for MANNITOL 20%

US Patents:	0
Applicants:	4
NDAs:	6
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	225
DailyMed Link:	MANNITOL 20% at DailyMed

Recent Clinical Trials for MANNITOL 20%

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

Sponsor	Phase
University Hospital, Geneva	Phase 3
Morten Hostrup, PhD	N/A
Ecole Polytechnique Fédérale de Lausanne	Early Phase 1

See all MANNITOL 20% clinical trials

Pharmacology for MANNITOL 20%

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

US Patents and Regulatory Information for MANNITOL 20%

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 20%	mannitol	INJECTABLE;INJECTION	014738-001	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
Hospira	MANNITOL 20%	mannitol	INJECTABLE;INJECTION	016269-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Miles	MANNITOL 20%	mannitol	INJECTABLE;INJECTION	016472-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Icu Medical Inc	MANNITOL 20% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	019603-004	Jan 8, 1990	AP	RX	No	No
B Braun	MANNITOL 20% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006-004	Jul 26, 1993	AP	RX	No	No

EU/EMA Drug Approvals for MANNITOL 20%

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

Market Dynamics and Financial Trajectory for Mannitol 20%

Market Overview

Mannitol, a 6-carbon sugar alcohol, is widely used in various industries, including pharmaceuticals, food, and personal care. The market for mannitol, particularly the 20% solution, is driven by several key factors.

Global Market Size and Growth

The global mannitol market was valued at approximately USD 417.48 million in 2022 and is projected to grow significantly over the next few years. By 2031, the market is expected to reach USD 754.70 million, growing at a Compound Annual Growth Rate (CAGR) of 6.8% from 2024 to 2031[1].

Regional Market Performance

Asia Pacific

The Asia Pacific region dominates the global mannitol market, accounting for more than half of the total market share. Countries like China and India are significant contributors due to increasing consumer health consciousness and rising cases of diabetes. The changing lifestyle and socioeconomic levels in these regions are expected to drive market demand over the next eight years[1].

Europe

Europe is anticipated to be the fastest-growing region in terms of mannitol market growth. This is attributed to expanding Research and Development (R&D) activities and rising demand from various end-user industries in the region[1].

North America and Other Regions

North America, along with Latin America and the Middle East and Africa, also play crucial roles in the global mannitol market. These regions are expected to contribute to the overall growth, driven by factors such as rising disposable incomes and increasing health consciousness[3][4].

Applications and End-Use Industries

Pharmaceutical Industry

Mannitol is extensively used as an excipient in the pharmaceutical industry to develop various pharmaceutical products. It is also used to treat kidney, brain, and heart disorders. The 20% mannitol solution is particularly important for its diuretic properties and is used in the treatment of acute renal failure, cerebral edema, and elevated intraocular pressure[1][5].

Food Industry

The food industry accounts for a significant portion of the mannitol market, with over 35% of the total market share. Mannitol is used as a food additive, and its demand is increasing due to changing consumer preferences towards diet and lifestyle management[1].

Other Applications

Mannitol is also used in industrial, surfactant, and personal care applications. Its versatility and multiple uses contribute to its growing market demand[3][4].

Market Drivers

Growing Population and Dynamic Lifestyle

The increasing global population and more dynamic lifestyles are key drivers of the mannitol market. These factors lead to higher demand for pharmaceuticals and food additives, which in turn drive the demand for mannitol[1][3].

Rising Cases of Diseases

The rise in cases of diabetes, obesity, and cardiovascular diseases, particularly in emerging markets like China and India, is another significant driver. Mannitol's use in treating these conditions contributes to its market growth[1][3].

Technological Advancements

Recent technological advancements, such as the use of lactic acid bacteria to synthesize mannitol, are expected to boost production yield while maintaining high purity. This innovation is likely to support market growth over the forecast period[1].

Financial Trajectory

Current Market Value

As of 2022, the global mannitol market was valued at around USD 417.48 million. In 2023, it was estimated to be around USD 445.87 million[1].

Projected Growth

The market is expected to grow at a CAGR of 6.8% from 2024 to 2031, reaching a value of USD 754.70 million by 2031. Other reports suggest a CAGR of around 4.24% to 4.50% over different forecast periods, leading to market values ranging from USD 652.25 million to USD 692.055 million by the end of the forecast period[1][3][4].

Competitive Landscape

The mannitol market is competitive, with several manufacturers producing various forms of mannitol, including 20% solutions. Companies like Albert David Limited, B. Braun Medical Inc., and others are key players in the market, offering a range of mannitol products for different applications[2][5].

Key Takeaways

• The global mannitol market is driven by a growing population, dynamic lifestyles, and an increase in certain diseases.
• The Asia Pacific region dominates the market, with significant contributions from China and India.
• Europe is expected to be the fastest-growing region due to expanding R&D activities.
• Mannitol is widely used in the pharmaceutical industry as an excipient and in the food industry as a food additive.
• Technological advancements are expected to boost production and purity.
• The market is projected to grow significantly over the next few years, reaching values up to USD 754.70 million by 2031.

FAQs

What is the current market value of the global mannitol market?

The global mannitol market was valued at around USD 417.48 million in 2022 and is estimated to be around USD 445.87 million in 2023[1].

What is the projected growth rate of the mannitol market?

The market is expected to grow at a CAGR of 6.8% from 2024 to 2031, although other reports suggest a CAGR ranging from 4.24% to 4.50% over different forecast periods[1][3][4].

Which region dominates the global mannitol market?

The Asia Pacific region dominates the global mannitol market, accounting for more than half of the total market share[1].

What are the primary applications of mannitol?

Mannitol is primarily used in the pharmaceutical industry as an excipient, in the food industry as a food additive, and in other applications such as industrial, surfactant, and personal care[1][3].

What are the key drivers of the mannitol market?

Key drivers include a growing population, dynamic lifestyles, rising cases of diseases like diabetes, and technological advancements in production[1][3].

What is the significance of the 20% mannitol solution in medical treatments?

The 20% mannitol solution is used as a diuretic and is crucial in the treatment of acute renal failure, cerebral edema, and elevated intraocular pressure[5].