Last Updated: August 10, 2026

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.30% In Plastic Container, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 0.30% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.

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  • What is the 5 year forecast for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% 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 DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-014 Jan 18, 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
Last updated: July 30, 2026

Market dynamics and financial trajectory for dextrose 5%, sodium chloride 0.33%, and potassium chloride 0.30% in plastic container

Dextrose 5% + sodium chloride 0.33% + potassium chloride 0.30% in a plastic container is positioned as a low-cost, broad-acuity IV maintenance or replacement fluid. Market dynamics are dominated by institutional purchasing cycles, bundled procurement, competitive commoditization with other balanced electrolyte solutions, and regulatory/labeling changes that affect interchangeability. Financial trajectory tends to be flat to modestly positive in periods of low inflation and stable hospital volume, but can swing sharply around supply disruptions, container/CGMP transitions, and payer or distributor switching.

This product category is typically priced and traded like a generic hospital fluid rather than an innovator asset; long-term profit is driven less by IP and more by manufacturing reliability, packaging cost (plastic container), and channel execution.

What is the market for “dextrose 5%, sodium chloride 0.33%, potassium chloride 0.30%” IV solution in plastic container?

Direct market definition (trade reality). The product competes in the “balanced electrolyte IV fluid / dextrose-containing maintenance fluid” segment used in hospitals, long-term care, and infusion settings. Its clinical role is to supply basal calories (dextrose) plus sodium and potassium for hydration and electrolyte maintenance, commonly under orders for patients needing both fluid and electrolytes.

Typical buyers and purchase patterns.

  • Hospitals: pharmacy and therapeutics committees set formularies; purchasing happens via GPO contracts and distributor bids.
  • IDNs and group purchasing organizations: tend to consolidate volume toward lowest total cost across clinically substitutable SKUs.
  • Distribution: channel margins and distributor switching can move unit volumes quickly between equivalent formulations.

Competitive set (substitutable products).

  • Other dextrose-saline-potassium combinations (same functional intent, different concentrations).
  • Balanced crystalloids without dextrose (e.g., lactated solutions) depending on institutional protocol.
  • Dextrose-saline products without potassium when electrolyte replacement is separately managed.
  • Alternative container formats (glass vs plastic) can substitute if clinical policy and supply allow.

How do hospital formularies and GPO contracting affect sales volume and pricing?

Formulary switching risk is high. In IV fluids, payer and clinician behavior typically centers on protocol compatibility, product availability, and procurement terms. If an IDN can swap to another balanced electrolyte SKU at lower contract pricing, it can do so without triggering the kind of prescribing friction seen with specialty drugs.

GPO economics.

  • Contract pricing compresses list-to-net spreads.
  • Rebates, admin fees, and volume commitments often determine which SKU wins.
  • A manufacturer’s financial outcome often tracks with whether it holds a core contract position versus losing bids.

Net price sensitivity. Unit pricing on fluids is highly sensitive to commodity inputs (salts, dextrose), packaging resin and container manufacturing costs, and logistics. Margins are typically resilient only when the supplier has stable supply and low disruption costs.

What are the key demand drivers for dextrose-saline-potassium maintenance fluids?

Hospital census and acuity. Demand is tied to inpatient volume, ED boarding, surgery volumes, ICU utilization, and length-of-stay patterns.

Protocol trends.

  • Institutions that standardize on dextrose-containing maintenance solutions generate steady baseline demand.
  • Protocol changes that shift potassium management to separate adjuncts can reduce volume of pre-mixed potassium-containing fluids.

Supply continuity. During shortages, substitution and emergency purchasing can increase volumes for the in-stock manufacturer even without protocol shifts. Those short-term surges often reverse after normal supply returns.

Which cost inputs and packaging factors move margins for plastic-container fluids?

Container and packaging are material.

  • Plastic container manufacturing costs depend on resin pricing, film/closure components, and line efficiency.
  • Any change in container supply can force reallocation of production, raising cost per unit.

Sterile manufacturing and compliance.

  • IV fluids require high reliability in aseptic processing, filtration, and final product integrity testing.
  • QA and batch release costs are fixed and scale with throughput. Underutilized capacity can pressure margins.

Commodity inputs.

  • Dextrose and electrolytes are commodity chemicals with price volatility tied to global production and energy costs.
  • Saline and potassium salts are usually not proprietary, so price risk is shared across suppliers.

How does competition from other IV electrolyte solutions change financial trajectory?

Commoditization effect. The product behaves like a generic-like hospital consumable where differentiation is limited to:

  • concentration match to protocol
  • container size/options (as available)
  • availability and lead time
  • contract pricing

Unit economics.

  • Winning share is often about procurement positioning and supply reliability rather than clinical differentiation.
  • Losing a GPO contract can reduce net revenue quickly, even if demand exists in the therapeutic category.

Scenario pattern (typical).

  • Stable period: volume holds with modest net price movement.
  • Contract renewal cycle: volume shifts to the lowest net-cost SKU.
  • Supply disruption: volume can spike for the “available” manufacturer; margin can be temporarily favorable or temporarily stressed depending on spot input costs and overtime logistics.

What does the financial trajectory usually look like for commoditized IV solutions?

For IV fluid products in this class, financial performance often follows this shape:

  • Baseline: flat-to-slightly up revenue with underlying hospital utilization growth.
  • Margin: pressured by net price competition; improved during periods of stable procurement pricing and efficient plant utilization.
  • Volatility: driven by supply interruptions, container availability constraints, and contract pricing resets.

Revenue growth is usually incremental. Because hospitals buy by protocol and contract, growth often comes from share gains in bidding cycles rather than from new prescriber adoption.

What regulatory milestones and labeling dynamics affect market outcomes?

FDA listing and safety updates. IV solutions rely on accurate labeling, stability data, and shortages reporting. Label changes tied to concentrations, contraindications, or warnings can influence protocol acceptance and stock management.

Drug shortages. Shortage designations can shift demand to available SKUs and affect temporary pricing and allocation.

Substitution and interchangeability. While pharmacy substitution varies by institution and state policy, IV fluids with comparable electrolyte intent typically face straightforward substitution.

What patent estate and exclusivity issues matter for this drug?

This product is generally treated as an off-patent, formulation-level hospital fluid. In practice, market access barriers are usually:

  • manufacturing quality and batch release
  • regulatory compliance and FDA listing
  • ability to maintain stable supply and contract positioning

Where patents exist, they are more likely to be packaging or process-level rather than to block broad generic entry for long periods. As a result, the competitive landscape is usually determined by manufacturing capacity and contracting rather than by litigation-driven exclusivity.

What generic entry risks exist and how do they affect pricing?

Entry threat is structural. For commodity IV solutions, the generic entry risk is high where:

  • manufacturing capacity is accessible
  • regulatory pathways are clear
  • bioequivalence-like proof is straightforward for the solution category

Pricing impact. New entrants can reduce net pricing through bids, but the realized impact depends on:

  • whether the hospital formulary requires the exact concentration match
  • whether GPO contracts lock in incumbents
  • whether the incumbent can match new low bid pricing without risking supply

What are the competitive landscape dynamics by container format and supplier footprint?

Plastic-container dominance. Plastic containers tend to be favored for handling and shipping efficiency. Suppliers that can deliver multiple container sizes, stable lot release, and consistent packaging supply typically hold better contract positions.

Regional manufacturing. Geographic distribution affects lead time and availability. Hospitals under shortage pressures often change buying behavior based on logistics performance.

Portfolio bundling. Large IV fluid makers often win through bundled offerings across multiple dextrose or electrolyte SKUs, making it easier for procurement to consolidate spend.

How do supply disruptions and shortages move market shares?

Shortages create temporary share gains. When one supplier is down, competing SKUs can increase volume quickly. After normalization, market share often partially reverts, but the incumbent may retain improved positioning if customers experience reliability during the shortage.

Financial effect on trajectory.

  • Revenue can jump during allocation periods.
  • Margin can either rise (if pricing holds and capacity is efficient) or fall (if overtime and expedite logistics raise unit costs).

What is the Orange Book status of this product and what does it imply?

For IV solutions in this concentration range, the Orange Book listing is often absent for primary actives as generic competition is common. Market access is usually constrained by manufacturing and regulatory listing rather than by long-lived exclusivity.

Implication for investors/licensing. If there is no meaningful exclusivity, the asset behaves like a supply-and-contract business, so valuation and earnings sensitivity skew toward throughput, plant utilization, and channel strength.

What licensing or commercial deals typically shape the market?

In practice, commercial outcomes are driven by:

  • GPO contracting wins
  • distributor agreements (inventory placement and bid participation)
  • capacity agreements and supply allocation arrangements during constrained periods

Licensing is less central than in specialty therapeutics because differentiation is limited and formulation-level IP is typically not the key economic lever for IV fluids.

Key financial drivers and KPIs to monitor

Commercial KPIs

  • Contract coverage in major GPOs
  • Share by hospital system or IDN
  • Net price (contract vs list) and bid competitiveness
  • Fill rate and lead time (especially during shortages)

Operational KPIs

  • Plant utilization and batch throughput
  • Yield and lot release pass rate
  • Packaging supply continuity (container components)
  • Regulatory inspection outcomes and CAPA costs

Risk KPIs

  • Input cost volatility (dextrose, electrolytes)
  • Freight and expedite exposure during constrained supply
  • Quality deviations that delay release or trigger write-offs

Key takeaways

  • The product competes as a commoditized IV maintenance fluid, so market dynamics are dominated by institutional procurement, GPO contracting, and supply continuity rather than IP.
  • Financial trajectory tends toward modest growth and compressed margins, with volatility around shortages, container supply constraints, and contract renewal cycles.
  • The biggest drivers of earnings are manufacturing reliability, throughput, and bid positioning that determines net price and volume.

FAQs

1) What other IV solutions substitute for dextrose 5%, sodium chloride 0.33%, potassium chloride 0.30%?

Other dextrose-saline-potassium pre-mixes with different electrolyte concentrations, dextrose-saline without potassium, and balanced crystalloids without dextrose can substitute depending on institutional protocol.

2) Why does container type (plastic) matter to buyers and procurement teams?

Plastic containers often affect handling efficiency, shipping logistics, and inventory workflow. Procurement typically prioritizes consistent packaging and reliable supply.

3) How do drug shortages change the economics of IV fluids?

Shortages can shift volume toward in-stock suppliers, but unit economics may worsen if expedites and higher input costs rise faster than contract pricing.

4) What operational failures most often disrupt IV fluid sales?

Aseptic processing deviations, stability/quality holds, and container closure integrity issues can delay lot release and cause immediate allocation losses.

5) Are patent challenges a major factor for this category?

For commodity IV fluids, market access barriers are usually operational and regulatory listing rather than long-lived exclusivity or litigation-driven entry delays.


References

  1. FDA. Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-shortages
  2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
  3. FDA. Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book) Guidance and FAQs. U.S. Food and Drug Administration. https://www.fda.gov/drugs/ensuring-safe-use-medicines/orange-book-approved-drug-products-therapeutic-equivalence-evaluations

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