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Last Updated: March 19, 2026

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Delflex W/ Dextrose 1.5% In Plastic Container patents expire, and when can generic versions of Delflex W/ Dextrose 1.5% In Plastic Container launch?

Delflex W/ Dextrose 1.5% In Plastic Container is a drug marketed by Fresenius Medcl and is included in three NDAs.

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

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Summary for DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:3

US Patents and Regulatory Information for DELFLEX 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 DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018379-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Medcl DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 020171-001 Aug 19, 1992 AT RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Medcl DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018883-001 Nov 30, 1984 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Medcl DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018883-004 Nov 30, 1984 AT RX Yes Yes ⤷  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

Summary

Last updated: February 4, 2026

Delflex with Dextrose 1.5% in a plastic container is a parenteral fluid typically used for hydration, electrolyte management, and as a vehicle for drug delivery. Its investment appeal depends on factors such as market penetration, regulatory status, manufacturing capacity, and clinical demand. Analyzing fundamentals involves evaluating the product’s current clinical use, competition, patent life, production costs, and market outlook.


What Is the Market Position of DELFLEX W/ DEXTROSE 1.5%?

Delflex is a generic intravenous (IV) solution with dextrose, marketed primarily in hospital settings. The global intravenous fluids market was valued at approximately USD 10 billion in 2022 and is projected to grow at 6-8% annually through 2030 [1].

Key stakeholders include pharmaceutical companies producing IV fluids, hospitals, and healthcare providers. Delflex faces competition from established brands like Baxter, B. Braun, and Hospira, offering similar dextrose solutions.

Market share specifics for Delflex are limited; it largely competes in regional markets, where price sensitivity and supply chain reliability influence purchasing decisions.

What Are the Regulatory and Patent Considerations?

The product's regulatory approvals, such as FDA clearance for U.S. markets or EMA approval for Europe, affirm compliance but typically do not confer exclusivity for generics unless associated with proprietary manufacturing processes or patents.

Delflex likely operates under a manufacturer's registration as a medical device or drug product. As a standard dextrose solution, it is subject to stability and sterility requirements rather than patent protection. Existing patents on formulations generally expire within 10-15 years post-approval, increasing generic proliferation.

What Are the Production and Cost Fundamentals?

Manufacturing costs involve raw material procurement (dextrose, water for injection, plastic packaging), sterilization, and quality control. Bulk sourcing of Dextrose monohydrate prices range from USD 0.80 to 1.20 per kilogram, with production costs estimated at USD 0.05 to 0.15 per unit (per 100 mL bag) depending on scale [2].

Plastic container costs vary by size and supplier but average USD 0.10 to 0.30 per container for standard 100 mL units. Sterilization via autoclaving adds to operational costs, but high-volume manufacturing reduces per-unit expenses.

Margins are typically narrow, with selling prices ranging from USD 0.50 to 2.00 per unit in various markets. Profitability depends on production efficiency, regulatory compliance, and market penetration.

What Is the Clinical and Regulatory Demand Outlook?

Dextrose solutions are essential in hospitals for hydration and drug administration, with steady demand driven by global healthcare infrastructure expansion.

The COVID-19 pandemic underscored the need for reliable IV supplies. Emerging markets demonstrate increased adoption of hospital-grade IV solutions, expanding demand.

The FDA and EMA maintain stable regulatory standards, but market expansion will rely on approval in countries with growing healthcare budgets and infrastructure investment, such as China, India, and parts of Africa.

What Are the Competitive Dynamics and Market Risks?

The market faces intense competition from established global manufacturers with economies of scale. Price competition is fierce, especially among generics. Supply chain disruptions, raw material price volatility, and regulatory delays pose risks.

Differentiation largely depends on supply reliability, pricing strategies, and establishing partnerships with hospital systems or distributers.

Patent expiration and patent challenges for similar formulations could lead to increased generic competition, impacting market share and pricing power.


Investment Fundamentals Summary

Factor Assessment
Market size USD 10 billion globally; steady growth
Competitive landscape Dominated by established players; low barriers to entry for generic manufacturers
Regulatory status Approved in multiple markets; patents typically expired or near expiration
Cost structure Marginal production and packaging costs; narrow profit margins
Demand forecast Consistent, driven by hospital utilization; regional growth in emerging markets
Risks Price competition, supply chain, regulatory delays

Key Takeaways

  1. Delflex with Dextrose 1.5% faces a stable but highly competitive market, with growth driven by healthcare infrastructure expansion.
  2. Price sensitivity and narrow margins require efficient manufacturing and strong distribution channels.
  3. Patent expiration and generic entry are imminent threats, emphasizing the importance of cost leadership.
  4. Regulatory standards are stable; market access expansion depends on gaining approval in emerging markets.
  5. Supply chain reliability and cost management will determine profitability in a commoditized product segment.

FAQs

1. What is the primary use of Delflex with Dextrose 1.5%?
It is used for hydration, electrolyte balance, and as a vehicle for medication delivery in hospitalized patients.

2. Are there patent protections for this formulation?
Likely no, as dextrose solutions are standard formulations with patent expiration typically within 10-15 years of approval.

3. What differentiates successful manufacturers in this market position?
Operational efficiency, reliable supply, cost control, and regulatory compliance are critical.

4. Which markets offer the highest growth potential?
Emerging markets such as China, India, and parts of Africa, where hospital infrastructure expands.

5. What challenges could impact investment returns?
Market saturation, intense price competition, raw material costs, and regulatory delays.


Sources

[1] MarketsandMarkets, "Intravenous (IV) Fluids Market by Product," 2022.

[2] U.S. Department of Agriculture, "Dextrose Monohydrate Prices," 2022.

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