You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

PHYSIOSOL IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Physiosol In Plastic Container, and what generic alternatives are available?

Physiosol In Plastic Container is a drug marketed by Hospira Inc and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in PHYSIOSOL IN PLASTIC CONTAINER is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for PHYSIOSOL IN PLASTIC CONTAINER?
  • What are the global sales for PHYSIOSOL IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for PHYSIOSOL IN PLASTIC CONTAINER?
Summary for PHYSIOSOL IN PLASTIC CONTAINER
Drug patent expirations by year for PHYSIOSOL IN PLASTIC CONTAINER

US Patents and Regulatory Information for PHYSIOSOL 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
Hospira Inc PHYSIOSOL IN PLASTIC CONTAINER magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate SOLUTION;IRRIGATION 018406-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Otsuka Icu Medcl PHYSIOSOL IN PLASTIC CONTAINER magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate SOLUTION;IRRIGATION 017637-002 Jul 8, 1982 RX 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 Physiosol in Plastic Containers

Last updated: July 30, 2025


Introduction

Physiosol, a sterile saline solution marketed primarily for hydration, wound cleansing, and various medical applications, has gained considerable attention given its widespread clinical use and the evolving pharmaceutical packaging landscape. Packaged predominantly in plastic containers, Physiosol’s market positioning and financial trajectory are influenced by a confluence of regulatory, technological, and competitive factors. A comprehensive understanding of these dynamics is essential for stakeholders aiming to optimize market strategies and forecast future financial performance.


Market Overview

The global sterile saline solution market, encompassing products like Physiosol, is projected to witness sustained growth driven by rising hospitalizations, the expanding scope of minimally invasive procedures, and increasing demand in outpatient and home healthcare settings. According to Research and Markets, the market is expected to grow at a compounded annual growth rate (CAGR) of approximately 5-6% through 2028, reflecting both demographic shifts and technological advancements.

Physiosol’s positioning in this landscape hinges on factors such as product purity, safety standards, and packaging innovation. Plastic containers, favored for their durability, lightweight nature, and cost-effectiveness, dominate the pharmaceutical packaging sector, particularly for fluids used in clinical settings.


Market Dynamics

1. Regulatory Environment

Regulatory approval remains a cornerstone for growth in the sterile saline segment. Agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) enforce stringent standards for manufacturing practices, container material safety, and product sterility. Recent regulatory updates emphasizing container integrity and endotoxin levels influence Physiosol's compliance strategies. Packaging in plastics necessitates adherence to biocompatibility standards to mitigate leachate risks and ensure patient safety.

2. Packaging Innovation and Material Trends

Plastic containers—particularly high-density polyethylene (HDPE), polypropylene, and specialized multilayer plastics—offer advantages such as impact resistance, chemical stability, and ease of sterilization. Innovations include container designs that facilitate easier handling and reduce contamination risk, critical in settings like hospitals and clinics.

The trend toward eco-friendly materials exerts upward pressure on suppliers to adopt recyclable or biodegradable plastics. This influences manufacturing costs and packaging supply chain dynamics but also opens avenues for differentiation in markets emphasizing sustainability.

3. Manufacturing and Supply Chain Factors

Manufacturers of Physiosol leverage flexible plastic molding technologies, enabling scalable and cost-efficient production. Supply chain considerations include sourcing high-quality plastics, ensuring sterilization consistency, and establishing reliable distribution channels amid global disruptions, such as pandemics and geopolitical uncertainties.

The COVID-19 pandemic underscored vulnerabilities in global supply chains, prompting manufacturers to diversify sourcing strategies and increase inventory buffers, influencing the financial outlook temporarily but fostering long-term stability.

4. Competitive Landscape

Physiosol faces competition from both generic saline solutions and branded products with differentiated features, such as added electrolytes or specific container designs. Market entrants are adopting advanced packaging features, including integrated safety caps and anti-reflux mechanisms, to gain differentiation. Strategic collaborations with packaging companies enhance product appeal and functionality.

Price competition remains fierce, pressuring profit margins. However, differentiated packaging that emphasizes safety and convenience can command premium pricing, supporting favorable financial trajectories.

5. Market Penetration and Geographic Expansion

Emerging markets exhibit rapid growth potential owing to expanding healthcare infrastructure and increasing medical procedural volumes. Regulatory pathways are often less complex, enabling quicker entry. However, price sensitivity and local packaging preferences influence adoption rates. Physiosol’s suppliers optimize pricing strategies and adapt packaging formats to local demands to accelerate market penetration.


Financial Trajectory

1. Revenue Drivers

Key revenue streams include direct sales to hospitals, clinics, and home healthcare providers. Innovation in packaging—such as tamper-evident seals, ergonomic containers, and eco-friendly plastics—serves as a catalyst for market expansion and premium pricing.

Overall revenue growth is expected to align with broader healthcare industry trends, combining organic growth via increased procedural volumes with strategic geographic expansions and product line enhancements.

2. Cost Structure and Margins

The cost of plastic raw materials remains sensitive to global commodity fluctuations. Efficient manufacturing and economies of scale in plastic container production underpin margin stability. Quality assurance costs, regulatory compliance expenditures, and R&D for packaging innovations exert upward pressure but are offset by premium pricing opportunities.

The modernization of packaging lines and investment in environmentally friendly plastics may impact short-term costs but are projected to enhance product appeal and compliance, fostering long-term profitability.

3. Investment and Capitalization

Manufacturers investing in advanced plastic molding technologies, sterilization processes, and eco-friendly packaging are likely to see accelerated growth potential. Capital expenditure allocations target increasing production capacity and upgrading facilities to meet evolving regulatory standards.

4. Market Risks and Uncertainties

Risks include raw material price volatility, regulatory compliance challenges, and competition from alternative packaging solutions. External factors such as global supply chain disruptions and environmental legislation can impact cost structures and product availability, influencing revenue streams and profitability.


Future Outlook and Strategic Recommendations

Physiosol in plastic containers is positioned for continued growth given the rising global demand for sterile saline solutions. Strategic focus on innovation—particularly in sustainable plastics and user-centric container design—will be pivotal. Manufacturers should monitor regulatory shifts and invest in supply chain resilience. Expansion into emerging markets offers substantial upside, provided adaptation to local preferences and regulatory requirements.

Digital transformation, including real-time supply chain monitoring and automation in manufacturing, can enhance efficiency. Additionally, collaborations with packaging innovators and eco-conscious material suppliers will bolster competitive advantage, enabling sustainable growth trajectories.


Key Takeaways

  • Market growth for Physiosol is driven by increasing healthcare procedural volumes and expanding geographic markets, especially in emerging economies.
  • Plastic container technology remains vital, with innovations in sustainability and user safety serving as differentiators.
  • Regulatory compliance and supply chain resilience are critical to maintaining steady financial performance.
  • Cost management and strategic investments in eco-friendly packaging solutions** will influence margins and brand perception.
  • Diversification of product formats and geographic expansion will position Physiosol proactively in the competitive landscape.

Frequently Asked Questions

1. How does packaging in plastics impact Physiosol’s marketability and compliance?
Packaging in plastics offers durability, lightweight handling, and cost efficiency. However, it necessitates adherence to biocompatibility and sterilization standards to ensure safety, influencing regulatory approval and market acceptance.

2. What are the key drivers for growth in the sterile saline market?
Increasing healthcare procedures, rising hospital admissions, outpatient care expansion, and advances in minimally invasive treatments drive demand for Physiosol.

3. How are sustainability trends influencing plastic container development?
Growing environmental concerns are prompting manufacturers to adopt recyclable, biodegradable, and eco-friendly plastics, affecting cost structures and product positioning.

4. What role does geographic expansion play in Physiosol’s financial trajectory?
Emerging markets present high growth potential due to healthcare infrastructure growth and lower regulatory hurdles, offering a pathway to diversified revenue streams.

5. What strategic steps should manufacturers pursue to enhance Physiosol’s market share?
Investing in innovative, sustainable packaging solutions; strengthening regulatory compliance; expanding into new markets; and leveraging strategic partnerships can bolster market position and profitability.


References

[1] Research and Markets. (2022). Global Sterile Saline Solution Market Forecasts.
[2] FDA Guidelines. (2021). Biocompatibility Standards for Medical Plastics.
[3] Smith, J., & Lee, K. (2020). Innovations in Pharmaceutical Packaging. Journal of Pharmaceutical Innovation.
[4] Green Pharma. (2021). Sustainable Packaging Trends in Healthcare.
[5] MarketsandMarkets. (2022). Healthcare Packaging Market by Material, Type, and Region.

More… ↓

⤷  Get Started Free

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.