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Last Updated: March 26, 2026

SORBITOL-MANNITOL Drug Patent Profile


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Which patents cover Sorbitol-mannitol, and when can generic versions of Sorbitol-mannitol launch?

Sorbitol-mannitol is a drug marketed by Hospira and Otsuka Icu Medcl and is included in three NDAs.

The generic ingredient in SORBITOL-MANNITOL is mannitol; sorbitol. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the mannitol; sorbitol profile page.

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Summary for SORBITOL-MANNITOL
US Patents:0
Applicants:2
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 149
Clinical Trials: 2
What excipients (inactive ingredients) are in SORBITOL-MANNITOL?SORBITOL-MANNITOL excipients list
DailyMed Link:SORBITOL-MANNITOL at DailyMed
Drug patent expirations by year for SORBITOL-MANNITOL
Recent Clinical Trials for SORBITOL-MANNITOL

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

SponsorPhase
PfizerPhase 1
Brigitte Jolles, MDPhase 2/Phase 3

See all SORBITOL-MANNITOL clinical trials

US Patents and Regulatory Information for SORBITOL-MANNITOL

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

Market Dynamics and Financial Trajectory for Sorbitol-Mannitol

Last updated: March 9, 2026

What is the current market size and growth rate for Sorbitol-Mannitol?

The global sorbitol market was valued at approximately USD 1.4 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% forecasted through 2030. Mannitol sits within the global sugar alcohols market, valued at USD 894 million in 2022, projected to grow at a CAGR of 4.4% over the same period [1, 2].

Sorbitol and Mannitol are often combined in pharmaceutical formulations, especially as excipients or active ingredients in osmotic laxatives and other oral medications. Though specific sales data for a combined Sorbitol-Mannitol formulation is limited, the segment is driven by growth in specialty pharmaceuticals and demand for sugar alcohols as excipients.

How does the regulatory landscape influence market potential?

Sorbitol's status as GRAS (Generally Recognized As Safe) by the FDA (Food and Drug Administration) facilitates its integration into oral pharmaceuticals and food products. Mannitol has been approved as a drug excipient and osmotic diuretic with a well-established safety profile.

Intellectual property protections are sparse for generic formulations, but patents on delivery methods and specific formulations can extend market exclusivity. Regulatory approval timelines, especially for new formulations, typically range from 12 to 36 months, impacting time-to-market and revenue streams.

Which factors influence demand for Sorbitol-Mannitol in the pharmaceutical industry?

  1. Osmotic Laxatives: Mannitol and sorbitol are used in medications treating constipation and bowel preparation, with steady demand due to aging populations.
  2. Drug Stabilization: As excipients, they stabilize active pharmaceutical ingredients (APIs), promoting consistent bioavailability.
  3. Taste Masking: Sugar alcohols improve palatability for pediatric and geriatric formulations.

The growth in the development of new osmotic and oral drug delivery systems will sustain demand. Market entry barriers include formulation complexity, manufacturing costs, and regulatory compliance.

What are the competitive landscape and key players?

Major producers include:

  • Cargill Inc.: Produces both sorbitol and mannitol, with vertical integration from feedstock to finished excipients.
  • Roquette Frères: Focuses on high-purity sugar alcohols for pharmaceutical applications.
  • Ingredion Incorporated: Supplies sorbitol-based excipients globally.

Market players compete primarily on purity levels, manufacturing capacity, and regulatory compliance. Innovation emphasizes improved bioavailability, reduced gastrointestinal side effects, and optimized manufacturing processes.

How will pricing trends and bioavailability impact future revenues?

Sorbitol and mannitol prices are influenced by feedstock costs, notably glucose and corn derivatives. Prices for sorbitol ranged from USD 2,000 to USD 2,500 per metric ton in 2022, with some regional variation. Mannitol prices are higher, averaging USD 3,000 to USD 3,500 per metric ton.

The rising demand for more bioavailable and stable formulations could command premium pricing. Additionally, the development of novel delivery systems involving these compounds can open higher-margin opportunities.

What are the main barriers and risks?

  • Regulatory hurdles delay product launches.
  • Supply chain disruptions affect raw material availability.
  • Competition from alternative excipients (e.g., polyethylene glycols).
  • Price volatility in raw materials impacts profit margins.

Financial trajectory projections

Forecasts indicate steady growth, with scale economies reducing manufacturing costs. Revenues for companies specializing in Sorbitol-Mannitol formulations could grow annually by 4-5%, driven by expanding pharmaceutical applications and geographic market expansion, particularly into emerging markets.

Key Takeaways

  • The combined market for sorbitol and mannitol, used as excipients and active ingredients, will grow at approximately 4.2-4.4% CAGR through 2030.
  • Demand is driven primarily by drug delivery applications, especially osmotic laxatives.
  • Major producers focus on high-purity, pharmaceutical-grade products.
  • Price volatility and regulatory hurdles remain risks but are offset by increasing demand in expanding markets.
  • Revenue growth depends on innovation, formulation advances, and capacity expansion.

Frequently Asked Questions

1. How does the regulatory approval process affect Sorbitol-Mannitol formulations?

Regulatory approval can take 12-36 months, depending on the formulation complexity and regional authorities. Approved formulations benefit from market exclusivity and faster adoption.

2. What are the primary applications of Sorbitol-Mannitol in pharmaceuticals?

They are used mainly as osmotic laxatives, excipients to stabilize APIs, and taste-masking agents in oral medications.

3. How do raw material costs influence market prices?

Feedstock prices, notably glucose for sorbitol and raw materials for mannitol, fluctuate with agricultural commodity markets, affecting production costs and market prices.

4. What competitive advantages do leading manufacturers have?

Leading companies leverage vertical integration, high product purity, strong regulatory compliance, and consistent supply chains.

5. What market segments could experience the fastest growth?

Emerging markets and new drug delivery platforms utilizing Sorbitol-Mannitol formulations are expected to grow rapidly.


References

  1. MarketsandMarkets. (2023). Sugar alcohols market. Retrieved from https://www.marketsandmarkets.com
  2. Grand View Research. (2022). Sugar alcohols market size. Retrieved from https://www.grandviewresearch.com

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