Last Updated: May 3, 2026

SORBITOL-MANNITOL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SORBITOL-MANNITOL?
  • What are the global sales for SORBITOL-MANNITOL?
  • What is Average Wholesale Price for SORBITOL-MANNITOL?
Summary for SORBITOL-MANNITOL
US Patents:0
Applicants:2
NDAs:3

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

SORBITOL-MANNITOL Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Market Presence and Application of Sorbitol-Mannitol?

Sorbitol-Mannitol combinations are primarily used in oral and injectable formulations for their osmotic laxative properties and as excipients. Its applications extend to bulk laxatives, dental products, and cryoprotectants in pharmaceutical formulations. The market for osmotic laxatives, including products containing sorbitol and mannitol, has sustained moderate growth, driven by increasing focus on gastrointestinal health, although growth is limited by the availability of newer agents.

How Does the Fundamental Profile of Sorbitol-Mannitol Look?

Market Dynamics

  • Market Size: Estimated global market value for laxatives core ingredients was approximately USD 5 billion in 2022, with sorbitol and mannitol making up subsets of this.
  • Growth Rate: Compound annual growth rate (CAGR) expected at 2-3% over the next five years, reflecting mature, stable segments.
  • End-Use Sectors: Pharmaceuticals (bulk laxatives, excipients), dental (desensitizing agents), food industry (sweeteners), and cryopreservation.

Product and Production Aspects

  • Manufacturing: Produced via hydrogenation of glucose derivatives, with large-scale manufacturers concentrated in China, India, and Europe.
  • Patents & IP: Limited patent activity related directly to sorbitol-mannitol combinations, as many formulations rely on established excipients.
  • Regulations: Both compounds recognized as Generally Recognized As Safe (GRAS) by the FDA and EFSA, facilitating market entry with minimal regulatory hurdles.

Competitive Landscape

  • Major Companies: Merck, Roquette, Cargill, and Aspen Pharmacare are leading producers of sorbitol and mannitol.
  • Pricing Trends: Prices remain relatively stable, with slight pressure from generic competition and raw material cost fluctuations (e.g., glucose prices).

Investment Considerations

  • Technology Innovation: Limited innovation; focus concerns the refinement of manufacturing and expanded applications.
  • Pipeline Potential: Few novel formulations or delivery methods involving sorbitol and mannitol are currently in advanced development stages.
  • Market Risks: Competition from newer, more effective agents for laxative use, and regulatory shifts affecting excipient approvals.

Financial Metrics and Indicators

Metric Data (2022) 5-Year Trend Notes
Market Size (USD) USD 5 billion Stable, 2-3% CAGR Driven by mature laxative and excipient markets
Raw Material Cost Stable with minor fluctuations Slight upward trend Impacted by glucose prices
Patent Activity Low Decreasing Limited innovation focus
Regulatory Status Approved globally Consistent Ease of compliance for new formulations

What Are the Key Investment Considerations?

  • Market Stability: Moderate growth for traditional uses; limited scope for rapid expansion.
  • Innovation Potential: Low, with minimal patent activity; most value lies in manufacturing efficiencies and application extensions.
  • Regulatory Environment: Facilitates market entry; no significant barriers.
  • Competitive Pressure: Moderate, from price competition and emerging alternatives.
  • Supply Chain Risks: Raw material price volatility affects margins.

Key Takeaways

  • The sorbitol-mannitol market is mature with steady demand primarily driven by their use as excipients and osmotic agents.
  • Growth prospects are limited; innovation is minimal.
  • Companies investing in manufacturing efficiency or exploring new pharmaceutical applications may find opportunities.
  • The regulatory landscape is favorable, with minimal approval hurdles.
  • Competitive pressure remains manageable but warrants monitoring of raw material costs.

FAQs

1. What are the primary medical uses of sorbitol and mannitol?
Sorbitol and mannitol mainly serve as osmotic laxatives, excipients in oral and injectable formulations, and cryoprotectants. Their role in dental products as desensitizing agents is also significant.

2. How does regulation impact sorbitol-mannitol formulations?
They are generally recognized as safe (GRAS) by regulatory agencies, simplifying approval processes and enabling widespread application without significant regulatory delays.

3. Are there new formulations involving sorbitol or mannitol in clinical development?
Few innovative formulations are currently in advanced development, primarily focusing on manufacturing improvements or niche applications.

4. What risks could impact investment in this space?
Market saturation, competition from newer agents, raw material price fluctuations, and regulatory changes could affect profitability.

5. Who are the leading producers of sorbitol and mannitol?
Merck, Roquette, Cargill, and Aspen Pharmacare dominate production, with geographic presence in Europe, the US, and Asia.


References:
[1] MarketResearch.com, "Global Laxatives Market Size, Trends & Forecast," 2022.
[2] FDA, "GRAS Notice Inventory," 2023.
[3] Industry analysis reports, 2022.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.