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Last Updated: December 16, 2025

INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Inpersol-zm W/ Dextrose 2.5% In Plastic Container patents expire, and what generic alternatives are available?

Inpersol-zm W/ Dextrose 2.5% In Plastic Container is a drug marketed by Fresenius Medcl and is included in one NDA.

The generic ingredient in INPERSOL-ZM W/ DEXTROSE 2.5% 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 2.5% IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER at DailyMed
Drug patent expirations by year for INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for INPERSOL-ZM W/ DEXTROSE 2.5% 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 2.5% IN PLASTIC CONTAINER calcium chloride; dextrose; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 019395-002 Mar 26, 1986 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 INPERSOL-ZM W/ DEXTROSE 2.5% in Plastic Container

Last updated: July 30, 2025

Introduction

INPERSOL-ZM W/ DEXTROSE 2.5% in plastic containers represents a specialized pharmaceutical product combining the active ingredient, likely a zinc supplement, with dextrose, formulated for parenteral administration. Its positioning within the global injectable electrolyte and mineral supplement market influences its commercial potential. This article examines the complex market dynamics impacting this drug's trajectory, analyzing factors such as demand drivers, competitive landscape, regulatory considerations, and pricing strategies.

Market Landscape Overview

The segment of injectable electrolytes and mineral supplements, including formulations like INPERSOL-ZM with dextrose, primarily serves hospital, clinical, and emergency care settings. These products are integral for managing electrolyte imbalances, dehydration, and specific nutrient deficiencies. The increasing global burden of dehydration, particularly in developing countries, alongside rising incidences of electrolyte disturbances among critically ill patients, fuels demand.

Furthermore, growth in inpatient care and parenteral nutrition—especially in pediatric, oncology, and intensive care units—augments the need for sterile, ready-to-use injectable formulations like INPERSOL-ZM.

Demand Drivers

Epidemiological Factors

The rising prevalence of dehydration-related conditions, notably among children and elderly populations, sustains demand. According to the World Health Organization, dehydration from diarrheal diseases remains a leading cause of morbidity and mortality in children under five, particularly in low- and middle-income countries [1].

Advancements in Healthcare Infrastructure

Expanding healthcare access and hospital infrastructure development, especially in emerging markets, create favorable conditions for injectable pharmaceuticals. The surge in healthcare budgets and investments in critical care infrastructure promote utilization of such products.

Regulatory Approvals and Longevity

Approval of INPERSOL-ZM in key markets boosts its commercial prospects. Extended patent life or exclusivity rights can secure market share, while regulatory hurdles may delay adoption or lead to market entry of generic alternatives.

Market Trends Toward Parenteral Nutrition

The increasing preference for parenteral nutrition in chronic and acute care settings elevates demand for electrolyte-rich solutions like INPERSOL-ZM. Furthermore, cystic fibrosis and oncology treatments with supportive therapy can further propel sales.

Competitive Landscape

The competitive environment features global pharmaceutical giants and regional players producing similar injectable mineral and electrolyte formulations. Key competitors include:

  • Fresenius Kabi: Known for its extensive portfolio of parenteral nutrition products.
  • Baxter International: Offers a wide array of sterile electrolyte solutions.
  • Hospira (now part of Pfizer): Manufactures injectable mineral supplements.

Differentiation hinges on factors like formulation efficacy, ease of administration, safety profile, and regulatory approvals. Patent expiry timelines may lead to increased generic competition, pressuring pricing strategies.

Regulatory Environment

The regulatory landscape greatly influences market feasibility and pricing. Stringent approval processes in jurisdictions like the U.S. (FDA), European Union (EMA), and China necessitate rigorous clinical data and manufacturing standards. Conversely, regulatory harmonization initiatives could streamline approvals for formulations like INPERSOL-ZM, accelerating market penetration.

Post-approval pharmacovigilance obligations also shape operating costs and time-to-market.

Pricing Strategies and Reimbursement Dynamics

Pricing for injectable electrolyte solutions is influenced by manufacturing costs, competitive prices, and reimbursement policies. In developed markets, insurance reimbursement schemes (Medicare, private insurers) significantly impact sales volume. Cost containment pressures may lead manufacturers to adopt value-based pricing or negotiate discounts.

In emerging markets, government procurement policies and tenders are often the primary purchasing mechanisms, emphasizing affordability.

Supply Chain and Distribution

Efficient cold chain management and sterile manufacturing are fundamental to maintaining product integrity. Distribution networks tailored to hospital pharmacies, clinics, and emergency units facilitate access.

Disruptions—such as those seen during the COVID-19 pandemic—highlight vulnerabilities within supply chains, impacting availability and revenue.

Financial Trajectory and Future Outlook

Growth Projections

The injectable electrolyte segment is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years, driven by expanding healthcare infrastructure and unmet medical needs [2].

For INPERSOL-ZM, assuming successful regulatory approval in high-growth markets and strategic partnerships, revenues could experience a compound annual growth rate of 8-10%. Early-stage adoption, combined with incremental market penetration, suggests a positive financial trajectory.

Revenue Streams

  • Domestic (core markets): Revenue from hospitals, clinics, and government tenders.
  • International: Licensing agreements and regional distributors can expand reach.
  • Parallel trade and generics: Patent expiration may enable generic manufacturing, impacting profit margins.

Cost Factors

Manufacturing costs, regulatory compliance, and marketing expenditures form core expense components. Investment in manufacturing capacity expansion and regulatory submissions influence overall profitability.

Risks and Challenges

  • Regulatory delays could hinder market entry.
  • Pricing pressures from generic entrants.
  • Competitive innovation from newer formulations or delivery methods.
  • Supply chain disruptions impacting availability.

Partnerships and Strategic Initiatives

Collaborations with government health agencies and hospital networks can accelerate adoption. Licensing deals and joint ventures with regional players may facilitate market entry in emerging economies.

Investment in clinical research demonstrating superior safety and efficacy would enhance marketability.

Conclusion

The market for INPERSOL-ZM W/ DEXTROSE 2.5% in plastic containers is poised for growth, supported by demographic trends, healthcare infrastructure expansion, and the vital role of electrolyte and mineral supplementation. While competitive and regulatory challenges persist, strategic positioning, innovation, and efficient supply chain management will influence its financial success. Manufacturers that adapt to evolving reimbursement policies and deliver high-quality, cost-effective products will secure favorable market share.


Key Takeaways

  • The increasing prevalence of dehydration and electrolyte disturbances globally sustains demand for injectable mineral supplements like INPERSOL-ZM.
  • Regulatory approvals, especially in emerging markets, are critical milestones that influence the product’s financial trajectory.
  • Competitive pressures and patent expirations necessitate strategic differentiation and cost management to maintain profitability.
  • Growth prospects are favorable, with projected revenues driven by healthcare infrastructure expansion and strategic market penetration.
  • Supply chain resilience and adherence to regulatory standards are vital for sustained market presence.

FAQs

  1. What are the primary clinical indications for INPERSOL-ZM W/ DEXTROSE 2.5%?
    It is used to correct electrolyte imbalances, manage dehydration, and support parenteral nutrition in hospitalized patients.

  2. How does regulatory approval impact the market success of this drug?
    Approvals in major markets validate safety and efficacy, enabling sales and reimbursement, and reducing barriers to entry.

  3. What competitive factors influence pricing for injectable electrolyte solutions?
    Manufacturing costs, patent status, regional reimbursement policies, and competing generic products are primary influences.

  4. Will patent expiry significantly affect INPERSOL-ZM’s market share?
    Yes. Patent expiration opens opportunities for generics, potentially reducing prices and market dominance of the original formulation.

  5. What strategies could manufacturers employ to enhance the financial trajectory of INPERSOL-ZM?
    Approaches include expanding clinical evidence, entering emerging markets through partnerships, optimizing supply chains, and maintaining regulatory compliance.


Sources:
[1] WHO. “Diarrhoeal Disease Fact Sheet”.
[2] MarketsandMarkets. “Injectable Electrolytes Market by Type”.

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