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Last Updated: December 22, 2024

MANNITOL; SORBITOL - Generic Drug Details


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

Mannitol; sorbitol is the generic ingredient in two branded drugs marketed by Hospira and Icu Medical Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for MANNITOL; SORBITOL
US Patents:0
Tradenames:2
Applicants:2
NDAs:3
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
DailyMed Link:MANNITOL; SORBITOL at DailyMed
Recent Clinical Trials for MANNITOL; SORBITOL

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

SponsorPhase
PfizerPhase 1
Brigitte Jolles, MDPhase 2/Phase 3

See all MANNITOL; SORBITOL clinical trials

Pharmacology for MANNITOL; SORBITOL
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL; SORBITOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira SORBITOL-MANNITOL mannitol; sorbitol SOLUTION;IRRIGATION 080224-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 018316-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 017636-001 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

MANNITOL; SORBITOL Market Analysis and Financial Projection Experimental

Mannitol and Sorbitol Market Dynamics and Financial Trajectory

Market Overview

The markets for mannitol and sorbitol are experiencing significant growth, driven by various factors including increasing health consciousness, rising demand for low-calorie sweeteners, and expanding applications in pharmaceuticals and food industries.

Mannitol Market

  • Current Market Size and Growth: The global mannitol market was estimated to be around $418.65 million in 2022 and is projected to reach $890.31 million by 2033, growing at a CAGR of 7.1% from 2023 to 2033[1][3].
  • Key Drivers: The market is driven by the increasing incidence of diabetes, the need for low-calorie sweeteners, and the substance's use in pharmaceuticals for treating brain, kidney, and heart problems. Mannitol's strong water solubility, low moldability, and excellent wetting properties make it a preferred choice over other sugar alcohols[1].
  • Regional Insights: China is expected to dominate the Asia-Pacific market, accounting for over 52.9% of the region's market share in 2023. India also plays a significant role, particularly due to its large consumer base and rising prevalence of diabetes and other health issues[1].

Sorbitol Market

  • Current Market Size and Growth: The global sorbitol market is estimated to be valued at $1.89 billion in 2024 and is expected to reach $3 billion by 2031, growing at a CAGR of 6.8% from 2024 to 2031[4].
  • Key Drivers: The sorbitol market is driven by its extensive use in food products like candy, baked goods, and chewing gum, as well as its role as a stabilizing and bulking agent in pharmaceuticals. Rising consumer preference for low-calorie, sugar-free food and beverages also contributes to its growth[4].
  • Regional Insights: North America, particularly the U.S., dominates the sorbitol market due to strong demand from pharmaceutical and food & beverage industries. The region's health-conscious consumer base and the presence of major pharmaceutical firms further boost the market[4].

Market Dynamics

Drivers

  • Increasing Health Consciousness: Consumers are increasingly seeking low-calorie and sugar-free alternatives, driving the demand for mannitol and sorbitol in food and beverages[1][4].
  • Pharmaceutical Applications: Both mannitol and sorbitol are used as excipients in pharmaceutical formulations, contributing to their market growth. Mannitol is particularly used in treating brain, kidney, and heart problems, while sorbitol acts as a stabilizing and bulking agent in liquid dosage forms and tablets[1][4].
  • Food and Beverage Industry: The use of mannitol and sorbitol in confectionery, baked goods, and other food products is on the rise due to their non-cariogenic and low-calorie properties[1][4].

Restraints

  • High Production Costs: The production of mannitol and sorbitol can be costly, which may act as a restraint to market growth[1][3].
  • Regulatory Challenges: Strict regulations and the availability of cheaper alternatives can also hinder the growth of these markets[1][3].
  • Competition from Other Sweeteners: The presence of other sugar alcohols like xylitol and erythritol can pose competition to mannitol and sorbitol[5].

Financial Trajectory

Mannitol

  • Revenue Projections: The mannitol market is expected to grow from $418.65 million in 2022 to $890.31 million by 2033, with a CAGR of 7.1% from 2023 to 2033[1].
  • Volume Sales: Volume sales of mannitol are projected to rise at 5.62% in 2023, with shipments reaching 66,998 MT in the same year[1].

Sorbitol

  • Revenue Projections: The sorbitol market is estimated to grow from $1.89 billion in 2024 to $3 billion by 2031, with a CAGR of 6.8% from 2024 to 2031[4].
  • Regional Revenue: North America, particularly the U.S., is expected to continue dominating the sorbitol market due to strong demand from pharmaceutical and food & beverage industries[4].

Regional Analysis

Mannitol

  • Asia-Pacific: China is the leading consumer of bulk mannitol in the Asia-Pacific region and is expected to account for over 52.9% of the region's market share in 2023. India also plays a significant role due to its large consumer base and rising health issues[1].
  • North America: This region is expected to contribute significantly to the mannitol market, particularly due to the rising incidence of intense renal failure and injury, and the use of mannitol to reduce intracranial pressure and treat cerebral edema[3].

Sorbitol

  • North America: The U.S. accounts for the largest share of the sorbitol market in North America, driven by strong demand from pharmaceutical and food & beverage industries. The growing health-conscious consumer base in the region further boosts the market[4].
  • Asia-Pacific: The region is expected to register strong growth in the sorbitol market due to the rising occurrence of kidney failure and the fast advancement of the pharmaceutical sector[4].

Product Life Cycle and Supply Chain

Mannitol

  • Product Life Cycle: Mannitol is in the growth phase of its product life cycle, with increasing demand driven by its applications in pharmaceuticals and food industries. The market is expected to continue growing positively over the next decade[1].
  • Supply Chain: The supply chain for mannitol involves manufacturers like Roquette Frères Company, Cargill, and SPI Pharma, among others. The production process benefits from the strong water solubility and excellent wetting properties of mannitol, making it a preferred choice in various applications[1][3].

Sorbitol

  • Product Life Cycle: Sorbitol is also in the growth phase, driven by its extensive use in food products and pharmaceuticals. The market is anticipated to grow moderately over the forecast period[4].
  • Supply Chain: The supply chain for sorbitol includes major players such as Cargill and other manufacturers. The production and distribution of sorbitol are influenced by its use in various industries, including food & beverages and pharmaceuticals[4].

Opportunities and Trends

Increasing Demand for Low-Calorie Sweeteners

  • The rising incidence of diabetes and other health issues is driving the demand for low-calorie sweeteners like mannitol and sorbitol. This trend is expected to continue, benefiting the market growth of both substances[1][4].

Expanding Pharmaceutical Applications

  • Both mannitol and sorbitol are increasingly used in pharmaceutical formulations, which presents a significant opportunity for market growth. Their use in treating various health conditions and as excipients in drug formulations is on the rise[1][4].

Growing Health Consciousness

  • Consumers are becoming more health-conscious, leading to an increased demand for sugar-free and low-calorie food products. This trend is expected to drive the market for mannitol and sorbitol in the food and beverage sector[1][4].

Key Takeaways

  • The mannitol market is projected to grow from $418.65 million in 2022 to $890.31 million by 2033, with a CAGR of 7.1%.
  • The sorbitol market is estimated to grow from $1.89 billion in 2024 to $3 billion by 2031, with a CAGR of 6.8%.
  • Increasing health consciousness, rising demand for low-calorie sweeteners, and expanding pharmaceutical applications are key drivers for both markets.
  • Regional markets, particularly Asia-Pacific for mannitol and North America for sorbitol, are expected to play significant roles in the growth of these markets.

FAQs

1. What is the projected market size of the mannitol market by 2033? The mannitol market is projected to reach $890.31 million by 2033, growing at a CAGR of 7.1% from 2023 to 2033[1].

2. What are the primary applications of mannitol? Mannitol is primarily used in pharmaceuticals for treating brain, kidney, and heart problems, as well as an additive in food and beverages due to its low-calorie and non-cariogenic properties[1].

3. Which region dominates the sorbitol market? North America, particularly the U.S., dominates the sorbitol market due to strong demand from pharmaceutical and food & beverage industries[4].

4. What are the key drivers for the growth of the sorbitol market? The key drivers include increasing applications in food products, pharmaceuticals, and rising consumer preference for low-calorie, sugar-free food and beverages[4].

5. How does the production cost affect the mannitol market? High production costs can act as a restraint to the growth of the mannitol market, although the market's overall positive trajectory is expected to continue[1][3].

Cited Sources

  1. Future Market Insights - Mannitol Market Size, Share, Outlook & Forecast by 2033
  2. SciELO - Putative metabolic pathway of mannitol and sorbitol and in sugarcane
  3. SNS Insider - Mannitol Market Size & Share Report Forecast 2023-2030
  4. Coherent Market Insights - Sorbitol Market Size & Share Analysis - Growth Trends
  5. ResearchGate - Sugar Alcohols: Chemistry, Production, Health Concerns and Nutritional Importance of Mannitol, Sorbitol, Xylitol, and Erythritol

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