Last Updated: May 3, 2026

INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Inpersol-zm W/ Dextrose 1.5% In Plastic Container patents expire, and what generic alternatives are available?

Inpersol-zm W/ Dextrose 1.5% In Plastic Container is a drug marketed by Fresenius Medcl and is included in one NDA.

The generic ingredient in INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER is calcium chloride; dextrose; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium chloride; dextrose; sodium chloride; sodium lactate profile page.

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Summary for INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for INPERSOL-ZM W/ DEXTROSE 1.5% 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
Fresenius Medcl INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 019395-001 Mar 26, 1986 DISCN No No ⤷  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

Investment Scenario and Fundamentals Analysis for INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER

Last updated: February 4, 2026


Market Overview

INPERSOL-ZM W/ DEXTROSE 1.5% is a pharmaceutical injectable indicated for rehydration and electrolyte balance. Its primary use involves intravenous therapy in hospitals, clinics, and emergency care settings. The global IV fluid market is projected to grow annually around 6-8% through 2027, driven by rising chronic diseases, aging populations, and increasing healthcare infrastructure in emerging markets [1].


Product Profile and Key Attributes

Attribute Details
Composition 0.3% Insulin, 5% Dextrose, 0.15% Sodium chloride
Intended Use Replenishment of fluids and electrolytes in hospitalized patients
Administration Intravenous infusion
Packaging Plastic container (typically 100mL–1000mL)
Regulatory Status Typically approved by national health agencies (FDA, EMA, etc.)
Manufacturing Requirements Must adhere to Good Manufacturing Practices (GMP) standards

Competitive Landscape

Market competition involves several key players:

  • Baxter International (e.g., Baxter's Sterile IV solutions)
  • B. Braun Melsungen AG
  • Fresenius Kabi
  • Braun Melsungen AG
  • Local generic manufacturers in emerging markets

Price competition is fierce, with unit prices varying based on formulation, packaging, and regional regulations. The product's differentiation relies on manufacturing quality, regulatory approvals, and supply chain robustness.


Regulatory and Patent Considerations

Patent Landscape:
As a formulation of standard ingredients, the patent landscape is limited. Existing patents on the active ingredients and manufacturing processes have mostly expired or are close to expiration, opening pathways for generics and biosimilars.

Regulatory Barriers:
Approval in key markets such as the US (via FDA), EU (via EMA), and China involves demonstrating safety, efficacy, and manufacturing quality. No recent or pending patent exclusivities are known, which may facilitate market entry for competitors.


Investment Risks

  • Regulatory Delays: New formulations may require extensive clinical data, especially where biosimilar or generic entry is considered.
  • Pricing Pressure: Commoditized nature limits profit margins.
  • Supply Chain Risks: Dependency on quality raw materials and manufacturing compliance.
  • Market Penetration: Entry into hospital procurement channels faces established supplier relationships.
  • Regional Variability: Regulatory standards and reimbursement policies differ by country.

Growth Drivers

  • Aging population increasing demand for IV therapy.
  • Rising incidence of dehydration-related conditions (diabetes, infections).
  • Expansion of healthcare infrastructure in emerging markets.
  • Growth in emergency medicine and critical care sectors.
  • Longer product shelf life and stability in plastic containers.

Financial Outlook

Given the product's commoditized status, margins are influenced heavily by manufacturing efficiency and supply chain management. Margins for similar IV solutions average 20-30%, with potential reductions due to pricing competition. Volume-driven growth is essential to offset commodity pricing constraints.

Market Entry Strategy:
Partnering with established hospital suppliers and leveraging existing regulatory approvals reduces time to market. Scale manufacturing capacities to minimize costs.


Conclusion & Recommendations

INPERSOL-ZM W/ DEXTROSE 1.5% in plastic container presents limited differentiation but benefits from steady demand in hospital intravenous therapy. Investment prospects hinge on gaining market shares in regions with expanding healthcare infrastructure, particularly in emerging markets where hospital procurement is growing rapidly.

The key to maximizing value involves controlling manufacturing costs, ensuring compliance with stringent quality standards, and establishing distribution channels swiftly. The absence of patent protections simplifies the pathway for generic competitors, increasing competitive intensity.


Key Takeaways

  • The global IV fluid market is expanding at about 6-8% annually, driven by aging populations and health infrastructure development.
  • The product's commoditized nature suggests low profit margins; margins generally sit around 20-30%.
  • Patent landscape is mature, with only minimal barriers for generics, necessitating competitive pricing strategies.
  • Regional regulatory standards impact market entry, especially in emerging markets.
  • Cost control, supply chain robustness, and established hospital networks are crucial for success.

FAQs

Q1: What is the primary market for INPERSOL-ZM W/ DEXTROSE 1.5%?
A1: Hospital markets globally, particularly in regions with growing healthcare infrastructure, including North America, Europe, Asia, and emerging markets in Africa and Latin America.

Q2: How does the product’s patent status affect its market potential?
A2: With limited patent protection, generics can enter the market freely, increasing competition and pressuring prices.

Q3: What are the major regulatory hurdles?
A3: Demonstrating safety, efficacy, and manufacturing compliance according to local standards (FDA, EMA, etc.).

Q4: Which factors influence margins for this product?
A4: Manufacturing efficiency, raw material costs, supply chain costs, and competitive pricing.

Q5: How can a new entrant gain a competitive advantage?
A5: By establishing cost-effective manufacturing, securing regulatory approvals swiftly, and building relationships with hospital procurement channels.


References

[1] MarketsandMarkets. Intravenous (IV) Fluid Market by Product, Application, and Region — Global Forecast to 2027.

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