Last Updated: August 10, 2026

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5% And Potassium Chloride 0.075% In Plastic Container, and what generic alternatives are available?

Dextrose 5% And Potassium Chloride 0.075% In Plastic Container is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER?
Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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
Baxter Hlthcare DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-004 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-011 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

Market Dynamics and Financial Trajectory for Dextrose 5% and Potassium Chloride 0.075% in Plastic Container

Last updated: July 30, 2026

Executive summary

Dextrose 5% with potassium chloride (KCl) in a plastic container is an IV “electrolyte plus dextrose” product used primarily for inpatient maintenance fluids and correction of mild hypokalemia. Its market dynamics are dominated by (1) hospital formulary volume, (2) supply continuity and substitution across equivalent electrolyte strengths, (3) competitive price pressure from authorized generics and multi-source KCl/dextrose solutions, and (4) procurement via group purchasing organizations. Financial trajectory is typically range-bound at the unit and gross-margin level, with revenue sensitivity to hospital utilization, seasonal variation in admissions, and disruptions at manufacturing sites rather than to new clinical demand creation.

What is DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% in plastic container used for, and who buys it?

Dextrose 5% and potassium chloride 0.075% IV solution is used for patients requiring both carbohydrates for maintenance and potassium supplementation, often in settings where clinicians want a controlled, low-dose KCl addition rather than higher-concentration electrolyte regimens. Commercial demand is driven by hospital inpatient workflows rather than outpatient prescribing.

What care settings drive volume?

  • Acute care hospitals (adult and pediatric inpatient)
  • Long-term care and specialty hospitals with IV capability
  • Emergency departments that stock maintenance IV solutions
  • Oncology and perioperative units when clinicians order maintenance fluids with electrolyte additions

Who purchases and how?

  • Hospital pharmacy directors and therapeutics committees set preferred products and concentrations.
  • Group purchasing organizations and wholesaler contracts determine net pricing.
  • Substitution is common when therapeutically equivalent formulations are available (same active ingredients and concentration ranges) and supply is adequate.

How big is the market and how does hospital procurement affect pricing for Dextrose 5% + 0.075% KCl IV?

The product sits in a larger hospital “maintenance fluids with electrolytes” bucket. Pricing and revenue are constrained by low-to-moderate willingness to pay and by heavy substitution.

Key drivers that raise net revenue

  • Formulary inclusion as a preferred “ready-to-use” solution.
  • Contract pricing that maintains share during shortages.
  • Consistent supply in a category that is vulnerable to upstream raw material and sterile manufacturing disruptions.
  • Pediatric and adult pathway standardization for specific KCl strengths.

Key drivers that compress net revenue

  • Tender-based purchasing and annual price resets.
  • Multi-source competition for the same concentration.
  • Conversion from branded to generic products.
  • Switching to alternatives: dextrose with different KCl percentage, or premixed electrolytes with different osmolar targets.

What “market dynamics” usually look like in practice

  • Small absolute molecule innovation value, large operational value for distributors and hospitals.
  • Revenue is more sensitive to unit volumes, replacement behavior during supply issues, and group contracting than to patent-driven premium pricing.

What financial trajectory should you expect for this IV maintenance solution?

For established, multi-source IV solutions, financial trajectory typically shows:

  • Stable or slowly declining list price over time due to generic competition.
  • Net revenue fluctuations driven by contract renewals and tender outcomes.
  • Margin compression as customers consolidate suppliers and push pricing down.

Stage-based trajectory pattern (typical for IV generics)

  1. Launch or re-launch period
    • Share gains through contracting and substitution readiness.
    • Higher net pricing than mature period, but quickly converges toward the lowest-cost multi-source set.
  2. Mature period
    • Share becomes procurement-driven.
    • Gross margin is constrained by commodity-like inputs and sterile manufacturing overhead.
  3. Shortage or supply disruption period
    • Temporary share reallocation and price relief can occur, depending on allocation policies and contractual terms.
  4. Post-shortage normalization
    • Revenue reverts as supply expands and customers re-optimize costs.

What market events most affect revenue for DEXTROSE 5% + 0.075% KCl?

Revenue is highly contingent on events that alter supply continuity or hospital ordering behavior.

Manufacturing and supply-chain events

  • Sterile fill-finish interruptions at the container-closure and aseptic manufacturing steps
  • Raw material price movements for dextrose, KCl, and container systems
  • Lead-time disruptions at plastic container suppliers
  • Regulatory or quality-related production holds

Demand-side and utilization events

  • Changes in inpatient census and acuity mix
  • Seasonal variation in admissions
  • Shifts in clinical guidelines that alter the KCl dosing pattern (for mild vs moderate supplementation)
  • Formularies moving to alternate premixes (different KCl strength or different dextrose concentration)

Who are the competitors and how does multi-source competition impact financials?

This category usually has multiple authorized generics and branded predecessors depending on the market history and originator labeling. Competition tends to be concentration-specific; switching between 0.075% KCl strengths is possible depending on therapeutic equivalence and protocol alignment.

Competitive structure that typically emerges

  • Low number of formulary “preferred” SKUs
  • High number of equivalent alternatives stocked as backup
  • Tender and rebate structures that reward broad availability rather than clinical differentiation

How competition translates to unit economics

  • Net pricing compresses toward average among the lowest-cost suppliers.
  • Marketing spend is limited; sales execution depends on contract penetration and distributor relationships.
  • Margin is driven by production scale, scrap rate, and supply reliability.

How does FDA regulatory status influence market dynamics and entry risk for this product?

For IV solutions like dextrose plus KCl, market access is usually controlled by Abbreviated New Drug Application (ANDA) pathways for generic versions and by current Good Manufacturing Practice (cGMP) compliance for sterile products.

Key regulatory mechanics impacting commercial entry

  • ANDA approvals and any amendments tied to container closure system or manufacturing process
  • Labeling differences that can hinder substitution if dosing instructions do not align with hospital protocols
  • Ongoing compliance activities that can restrict supply even when products remain approved

What patent or exclusivity issues drive pricing for Dextrose 5% + 0.075% KCl?

For generic-like IV solutions, pricing power generally hinges less on active patents and more on whether exclusivity or market exclusivity blocks generic competition. In most mature IV solution categories, patent estates are either expired or are narrow to specific manufacturing processes, packaging configurations, or labeling details.

Practical implication for investors and litigators

  • The revenue outlook usually behaves like a generic, not a branded, product.
  • Financial upside is more tied to manufacturing scale-up and contract wins than to holding off generic entry.

What are the most common generic entry and substitution scenarios?

For this type of premixed IV solution, substitution is driven by:

  • Same strength and dosing instructions accepted by hospital formularies
  • Equivalent plastic container systems or acceptable interchangeability
  • Supply availability and delivery reliability

Scenarios that can change financial trajectory quickly

  • New multi-source entrant wins a hospital group contract
    • Share shifts rapidly as pharmacies swap their “preferred” order
  • Supply shortage of one SKU pushes switching to another multi-source product
    • Temporary revenue uplift for the in-stock suppliers, followed by normalization
  • Labeling or concentration mismatch
    • Slower switching because pharmacy protocols may require specific KCl percentages

How do procurement contracts and wholesaler dynamics affect unit volumes?

In the US market, contract structures and wholesaler inventory decisions are major determinants of what hospitals buy.

What typically drives a SKU to win or lose

  • Placement on group purchasing lists and formulary ranking
  • Wholesaler allocation decisions during constrained supply
  • Pharmacy conversion speed from one supplier to another
  • Return policies and adverse event reporting that affect supplier trust

Financial sensitivity to contract timing

  • Revenues spike around contract transition periods (winner takes share quickly).
  • Net revenue can fall sharply after contract renegotiation if the supplier is displaced in tender rounds.

What is the revenue model for this product inside a broader IV fluids portfolio?

This product generally functions as:

  • A “workhorse” SKU in maintenance fluids kits and inpatient IV stock
  • A complement to other dextrose plus electrolyte mixes across strengths

Portfolio-level dynamics

  • Share gains in one strength can cannibalize another SKU unless tied to protocol-specific dosing.
  • Companies that supply multiple dextrose-electrolyte formulations often lock in higher total IV volume and reduce per-SKU volatility.

What geographic and channel factors matter most?

Geography

  • US hospital procurement drives most mainstream demand due to tender penetration and standardized formulary practices.
  • Canada and EU markets follow similar hospital procurement logic but with different regulatory and reimbursement structures.

Channel

  • Direct hospital contracts and distributor-led tenders dominate.
  • Institutional buyers care about delivery lead-time and substitution acceptability more than branding.

Key takeaways

  • Dextrose 5% + potassium chloride 0.075% in plastic container behaves like a mature, multi-source IV maintenance solution: volume-driven, contract-driven, and substitution-sensitive.
  • Financial trajectory is usually range-bound with downward pressure on net pricing from multi-source competition and tender-based purchasing.
  • Revenue volatility comes primarily from supply continuity events, contract renegotiations, and hospital formulary switching rather than from patent or clinical breakthrough dynamics.
  • Competitive advantage tends to be operational: reliable sterile manufacturing at scale, low defect and scrap rates, and broad contract coverage across hospital groups.

FAQs

  1. What hospital conditions drive orders for dextrose 5% with low-dose potassium chloride (0.075%)?
  2. How does switching between KCl strengths (including 0.075%) affect hospital formulary adoption and utilization?
  3. What causes temporary pricing or allocation spikes for IV dextrose-electrolyte solutions during supply disruptions?
  4. How do ANDA approvals and labeling details influence interchangeability and substitution in hospitals?
  5. What contract levers (GPO placement, rebate structures, delivery SLAs) most impact long-run market share for this SKU?

References

  1. US Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). FDA.
  2. US Food and Drug Administration. ANDA Drug Product Information. FDA.
  3. US Food and Drug Administration. Drug Supply Chain and Shortage Reporting. FDA.

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