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Last Updated: December 23, 2024

MANNITOL 5% Drug Patent Profile


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When do Mannitol 5% patents expire, and what generic alternatives are available?

Mannitol 5% is a drug marketed by B Braun, Hospira, and Icu Medical Inc. and is included in four NDAs.

The generic ingredient in MANNITOL 5% 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.

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Summary for MANNITOL 5%
Drug patent expirations by year for MANNITOL 5%
Recent Clinical Trials for MANNITOL 5%

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

SponsorPhase
University Hospital, GenevaPhase 3
Morten Hostrup, PhDN/A
University Hospital Inselspital, BerneEarly Phase 1

See all MANNITOL 5% clinical trials

Pharmacology for MANNITOL 5%
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 5%

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% mannitol INJECTABLE;INJECTION 016080-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc MANNITOL 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-001 Jan 8, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MANNITOL 5% mannitol INJECTABLE;INJECTION 016269-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun MANNITOL 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-001 Jul 26, 1993 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MANNITOL 5%

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

MANNITOL 5% Market Analysis and Financial Projection Experimental

Mannitol Market Dynamics and Financial Trajectory

Market Overview

The mannitol market is poised for significant growth, driven by several key factors. In 2022, the global mannitol market was valued at approximately USD 417.48 million to USD 418.65 million[1][3][4].

Growth Drivers

Increasing Population and Lifestyle Changes

The global population is increasing, and lifestyle changes are leading to a rise in certain diseases. This trend is expected to favor the mannitol market, as mannitol is used in the treatment of various health conditions, including brain, kidney, and heart problems[1][3][4].

Pharmaceutical Applications

Mannitol is widely used as an excipient in the pharmaceutical industry for the formulation of pharmaceutical products. Its role in tableting applications as a bulking agent further supports its demand[1][3][4].

Food and Beverage Industry

The demand for low-calorie products and drinks, particularly in regions like Asia Pacific, is on the rise. Mannitol, which does not affect blood sugar levels, is an excellent choice for diabetic individuals, contributing to its growing demand in the food and beverage sector[4].

Market Size and Forecast

  • 2022: The market size was estimated to be around USD 417.48 million to USD 418.65 million[1][3][4].
  • 2023: Projected to reach USD 445.87 million to USD 890.31 million, with a significant increase due to various market drivers[1][3].
  • 2031/2033: Expected to grow to USD 754.70 million by 2031 at a CAGR of 6.8%[3], or USD 692.055 million by 2029 at a CAGR of 4.24%[4], and USD 890.31 million by 2033 at a CAGR of 7.1%[1].

Regional Analysis

Asia Pacific

This region is anticipated to hold a significant market share due to rising health awareness, increased urbanization, and growing disposable income. Countries like China and India are driving the demand due to changing eating habits and the need for low-calorie products[4].

Application Segments

Pharmaceuticals

Mannitol is crucial in the pharmaceutical industry for its use in treating various medical conditions, including acute renal failure, increased intraocular pressure, and as a diuretic to manage fluid overload[5].

Food and Beverage

Its use as a sweetener and bulking agent in food products, especially for diabetic individuals, is a significant application segment[4].

Industrial

Mannitol also has industrial applications, although these are less prominent compared to its pharmaceutical and food uses[4].

Production and Cost Dynamics

Production Process

The production of mannitol involves enzymatic reactions, such as the reduction of D-fructose to mannitol using mannitol dehydrogenase (MDH) and the continuous regeneration of the NADH cofactor. This process is optimized to reduce the consumption of costly enzymes and improve selectivity and efficiency[2].

Cost Reduction

The use of fed-batch bienzymatic reactors and the continuous in-situ regeneration of the NADH cofactor significantly reduce production costs. This method ensures mild operating conditions and high selectivity, making the process more economical[2].

Market Challenges

Competition

The mannitol market faces competition from other excipients and sweeteners, which can impact market share and pricing strategies.

Regulatory Environment

Changes in regulatory policies and standards can affect the production and use of mannitol, requiring manufacturers to adapt to new guidelines.

Financial Performance

  • Revenue Growth: The market is expected to experience steady revenue growth, driven by increasing demand from pharmaceutical and food industries.
  • CAGR: The compound annual growth rate (CAGR) is projected to be around 4.24% to 7.1% over the forecast period, indicating a robust growth trajectory[1][3][4].

Key Players and Market Strategies

Major players in the mannitol market are focusing on expanding their production capacities, improving manufacturing processes, and diversifying their product portfolios to meet the growing demand.

Conclusion

The mannitol market is poised for significant growth, driven by increasing demand from the pharmaceutical and food industries, along with favorable demographic and lifestyle trends. The market's financial trajectory indicates a strong potential for revenue growth, with a projected CAGR of 4.24% to 7.1% over the next several years.

Key Takeaways

  • The global mannitol market was valued at approximately USD 417.48 million to USD 418.65 million in 2022.
  • The market is expected to grow at a CAGR of 4.24% to 7.1% over the forecast period.
  • Increasing population, lifestyle changes, and the rise in certain diseases are key drivers of the market.
  • Asia Pacific is expected to hold a significant market share due to rising health awareness and urbanization.
  • Mannitol is widely used in pharmaceuticals, food, and beverage industries.

FAQs

Q: What is the current market size of the mannitol market?

The current market size of the mannitol market was estimated to be around USD 417.48 million to USD 418.65 million in 2022[1][3][4].

Q: What is the projected CAGR for the mannitol market?

The projected CAGR for the mannitol market is between 4.24% and 7.1% over the forecast period[1][3][4].

Q: What are the primary applications of mannitol?

Mannitol is primarily used in the pharmaceutical industry as an excipient, in the food and beverage industry as a sweetener and bulking agent, and in industrial applications[1][3][4].

Q: How does the production process of mannitol impact its cost?

The production process involving fed-batch bienzymatic reactors and continuous in-situ regeneration of the NADH cofactor significantly reduces the consumption of costly enzymes, thereby reducing production costs[2].

Q: Which region is expected to hold a significant market share in the mannitol market?

The Asia Pacific region is expected to hold a significant market share due to rising health awareness, increased urbanization, and growing disposable income[4].

Sources

  1. Future Market Insights: Mannitol Market Size, Share, Outlook & Forecast by 2033.
  2. MDPI: Multiobjective Optimization of a Fed-Batch Bienzymatic Reactor for Mannitol Production.
  3. SkyQuestT: Mannitol Market Growth, Size & Share Analysis | 2031.
  4. Knowledge Sourcing: Mannitol Market Size & Share: Industry Report, 2024 - 2029.
  5. StatPearls: Mannitol | Treatment & Management | Point of Care.

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