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Last Updated: December 30, 2025

SORBITOL 3% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Sorbitol 3% In Plastic Container, and what generic alternatives are available?

Sorbitol 3% In Plastic Container is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in SORBITOL 3% IN PLASTIC CONTAINER is sorbitol. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sorbitol profile page.

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Summary for SORBITOL 3% IN PLASTIC CONTAINER
Drug patent expirations by year for SORBITOL 3% IN PLASTIC CONTAINER
Recent Clinical Trials for SORBITOL 3% IN PLASTIC CONTAINER

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

SponsorPhase
Sunnybrook Health Sciences CentrePHASE3
Applied Therapeutics, Inc.PHASE3
Empros Pharma ABPHASE2

See all SORBITOL 3% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for SORBITOL 3% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun SORBITOL 3.3% IN PLASTIC CONTAINER sorbitol SOLUTION;IRRIGATION 016741-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare SORBITOL 3% IN PLASTIC CONTAINER sorbitol SOLUTION;IRRIGATION 017863-001 Approved Prior to Jan 1, 1982 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare SORBITOL 3% IN PLASTIC CONTAINER sorbitol SOLUTION;IRRIGATION 018512-001 May 27, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 3% in Plastic Container

Last updated: August 7, 2025

Introduction

Sorbitol 3% in plastic containers represents a niche yet critical segment within the global pharmaceutical and healthcare markets. Generally employed as a viscous, sweetening, or humectant agent, sorbitol's applications extend across oral care, skin care, ophthalmic formulations, and pharmaceutical excipients. Understanding the underlying market dynamics and assessing the financial trajectory of this specific formulation demand a strategic analysis given its unique positioning and the evolving landscape of consumer preferences, regulatory standards, and technological advancements.

Market Overview

Sorbitol and Its Market Role
Sorbitol, a sugar alcohol derived primarily from glucose, serves as a multifunctional excipient, offering properties such as moisture retention, sweetness, and stability. The 3% concentration in plastic containers indicates a formulation optimized for topical, ophthalmic, or oral applications, emphasizing ease of handling, dosing accuracy, and patient compliance.

Key Applications and Industry Adoption
The pharmaceutical industry perceives sorbitol 3% in plastic containers as integral to formulations requiring viscosity control and moisture retention. Its applications span:

  • Oral cleansing gels
  • Ophthalmic lubricants
  • Topical dermatological preparations
  • Medical device lubricants

The convenience of pre-filled plastic containers facilitates dosing accuracy, sterility, and portability, driving demand among healthcare providers and consumers.


Market Dynamics

Drivers of Growth

1. Rising Demand for Over-the-Counter (OTC) and Personal Care Products
The global surge in OTC and personal care products contributes significantly to the advancement of sorbitol-based formulations. Consumers increasingly prefer pre-measured, user-friendly packaging, boosting the adoption of plastic container formats. The convenience and safety features align with consumer preferences for everyday use products.

2. Expansion in Ophthalmic and Dermatological Markets
With the increasing prevalence of dry eye syndrome, allergic conjunctivitis, and skin hydration needs, ophthalmic lubricants and topical moisturizers with sorbitol 3% are witnessing expanding markets. The non-toxic, non-irritating profile of sorbitol enhances its appeal, especially in sensitive formulations.

3. Regulatory Favorability
Regulatory authorities such as the FDA and EMA recognize sorbitol as Generally Recognized As Safe (GRAS) when used within specified limits, facilitating market access. Ongoing evaluations favor continued usage, encouraging cosmetic and pharmaceutical manufacturers to expand product portfolios.

4. Innovation in Packaging and Formulation
Advancements in plastic container manufacturing—such as aseptic packaging, tamper-evident seals, and environmentally sustainable plastics—boost product appeal and compliance with modern standards. These innovations elevate consumer confidence and meet regulatory expectations.

Challenges Restraining Market Growth

1. Competition and Substitution Risks
Sorbitol faces competition from alternative humectants or sweeteners such as glycerol and xylitol. Market players must differentiate through formulation stability, cost efficiencies, or user experience.

2. Regulatory and Quality Compliance
Stringent regulations regarding packaging materials, residual monomers, and extractables require continuous quality assurance. Non-compliance can result in product recalls and limited market access.

3. Supply Chain Constraints
Fluctuations in raw material prices, especially glucose or sorbitol raw materials, can induce cost volatility. Disruptions in the supply chain, impacted by geopolitical issues or manufacturing bottlenecks, threaten consistent product availability.


Financial Trajectory

Market Size and Forecast (2023-2030)

Current Market Valuation
The global market for sorbitol and sorbitol-containing formulations, including those in plastic containers, is estimated to be valued at approximately $1.2 billion in 2023[1]. This includes both bulk raw material sales and finished packaged products.

Growth Outlook
The compound annual growth rate (CAGR) is projected to be 7-9% over the next seven years. This growth is driven by rising demand for topical and ophthalmic formulations and innovative packaging solutions, particularly in emerging economies.

Segment-Specific Financial Trajectory

  • Pharmaceutical Sector: Expected CAGR of ~8%, owing to increasing demand from dermatology, ophthalmology, and wound care applications.
  • Personal Care Sector: A CAGR of ~9%, driven by rising consumer preference for premium, pre-filled, single-use products.

Pricing Dynamics

Pricing for sorbitol 3% in plastic containers remains influenced by raw material costs, manufacturing scale, and packaging innovations. Premium formulations with specialized plastics or added features command higher price points, influencing revenue streams favorably.

Profitability and Investment Outlook

Manufacturers investing in advanced packaging technology, quality assurance, and supply chain resilience can anticipate enhanced margins, benefit from higher market penetration, and expand into emerging markets. Strategic alliances, licensing, and R&D will catalyze product differentiation, leading to sustained revenue growth.


Regional Market Insights

North America

Dominates the market with extensive pharmaceutical and OTC product consumption, driven by high healthcare awareness and regulatory support. The U.S. accounts for approximately 45% of the regional share, with continued growth expected.

Europe

A mature market emphasizing stringent regulation and innovation in packaging solutions. The European market benefits from the popularity of preservative-free formulations.

Asia-Pacific

Projects the highest growth potential (~10% CAGR) due to burgeoning healthcare infrastructure, rising disposable incomes, and expanding consumer base in China, India, and Southeast Asia.

Latin America and Middle East & Africa

Emerging markets with increasing pharmaceutical manufacturing capacity and rising demand for over-the-counter products.


Regulatory and Industry Standards

Ensuring compliance with pharmacopeial standards (USP, EP, JP) for sorbitol purity and quality control is vital. Additionally, packaging materials must conform to regulations regarding safety, toxicity, and environmental sustainability. The adoption of novel plastics with improved barrier properties and reduced environmental impact aligns with global sustainability trends.


Conclusion and Strategic Recommendations

The market for sorbitol 3% in plastic containers is poised for steady growth, driven by innovative packaging, expanding applications, and increasing consumer demand. Companies should prioritize R&D to develop enhanced formulations, invest in sustainable packaging, and expand presence in emerging markets to leverage this trajectory.


Key Takeaways

  • The global market for sorbitol-based products in plastic containers is projected to grow annually by approximately 7-9% through 2030, fueled by demand in pharmaceutical, personal care, and ophthalmic sectors.
  • Innovation in packaging technology and formulations will be central to maintaining competitive advantage and meeting regulatory standards.
  • Regional dynamics show robust growth potential in Asia-Pacific, complemented by mature markets like North America and Europe continuing steady expansion.
  • Price and supply chain stability remain critical; strategic raw material sourcing and manufacturing efficiency are vital.
  • Sustainability in packaging materials will increasingly influence consumer preference and regulatory approvals.

FAQs

Q1: What are the primary applications of sorbitol 3% in plastic containers?
A1: It is primarily used in ophthalmic lubricants, topical dermatological formulations, oral care products, and as an excipient in various pharmaceutical preparations requiring viscosity and moisture retention.

Q2: How does packaging innovation influence market growth?
A2: Advanced plastic containers improve product stability, ease of use, and safety, thereby increasing consumer acceptance and compliance, which directly drives market adoption.

Q3: What regulatory hurdles must manufacturers navigate?
A3: Manufacturers must comply with pharmacopeial standards, packaging safety regulations, and environmental policies, particularly regarding residual chemicals and plastic sustainability.

Q4: Which regions offer the most growth opportunities?
A4: The Asia-Pacific region presents the highest growth potential, driven by expanding healthcare infrastructure and rising consumer demand across emerging markets.

Q5: What competitive strategies should companies adopt?
A5: Investment in R&D, sustainable packaging, supply chain resilience, and strategic partnerships in emerging markets are essential for maintaining competitiveness and capturing growth opportunities.


Sources

[1] Grand View Research. "Sorbitol Market Size, Share & Trends Analysis Report," 2023.

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