Last Updated: August 8, 2026

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dialyte Lm/ Dextrose 1.5% In Plastic Container patents expire, and what generic alternatives are available?

Dialyte Lm/ Dextrose 1.5% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DIALYTE LM/ 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. Three 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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  • What is the 5 year forecast for DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER?
  • What are the global sales for DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER?
Summary for DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for DIALYTE LM/ 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
B Braun DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018460-007 Jan 29, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018460-002 Approved Prior to Jan 1, 1982 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 29, 2026

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER Market Dynamics and Financial Trajectory (US)

DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER is a dialysis-concentrate/solution-style product used in chronic kidney disease and related fluid-management workflows. The commercial trajectory for this specific strength and container is driven primarily by (1) hospital and clinic utilization of continuous renal replacement therapy (CRRT) and dialysis-associated supply purchasing, (2) U.S. payer contracting at the GPO and wholesaler level, (3) inventory and substitution risk across equivalent dextrose concentrations and solution formats, and (4) regulatory and labeling stability that limits “functional” switching once procurement specifications lock in.

The market is typically low-dollar per-unit but high-volume by facility, with revenue largely dependent on consistent channel placement, contract renewals, and supply continuity rather than brand-level prescription pull-through.


What is DIALYTE LM / DEXTROSE 1.5% in plastic container and where is it used?

Direct answer: DIALYTE LM/ DEXTROSE 1.5% in plastic container is used as a dextrose-containing dialysis solution in dialysis/renal-care settings, supplied for use in clinical dialysis workflows where fluid balance and dialysate composition matter. (Product naming and exact indication depend on the specific FDA labeling package insert for the marketed configuration.)

Key market-facing attributes that drive uptake

  • Strength specificity: 1.5% dextrose content is a procurement spec point that affects compatibility with facility protocols for glucose management and solute balance.
  • Plastic container format: Plastic-container solutions face different procurement constraints versus non-plastic formats, including storage and handling norms in hospital pharmacies and renal therapy units.
  • Clinical workflow fit: Dialysis-related supply contracts are often built around protocol-driven order sets, not clinician “choice,” which increases stickiness once a product is standardized.

How does pricing work for dialysis solutions like DEXTROSE 1.5% in plastic containers?

Direct answer: Pricing is typically determined by institutional contracting rather than retail channel pricing. Revenue is sensitive to contract pricing, wholesaler markups, and GPO terms.

Typical dialysis-supply pricing dynamics

  • GPO and IDN contracts dominate unit economics. Large integrated delivery networks and renal specialty providers use category management to lock pricing across brands and equivalent solutions.
  • White space exists for substitutions when protocols are flexible. If a facility’s renal pharmacy protocol allows equivalent substitution by dextrose concentration or container type, contract renegotiations can pressure net price.
  • Supply continuity is a pricing factor. Shortages can temporarily reduce substitution tolerance and raise realized pricing within contract constraints.

What usually drives net revenue changes

  • Contract renewal terms (annual or multi-year)
  • Case-mix or census in renal units (affects volume)
  • Switch events triggered by formulary updates, contracting disputes, or supply interruptions
  • Distribution channel mix (direct ship vs wholesaler fill rate)

What market dynamics impact demand for DIALYTE LM / dextrose solutions?

Direct answer: Demand moves with dialysis utilization and institutional protocol standardization more than with brand-level marketing.

Demand drivers

  • CKD and acute kidney injury incidence: Higher AKI burden increases CRRT/dialysis throughput.
  • ICU utilization: CRRT is ICU-intensive, so ICU bed occupancy correlates with dialysis solution volume.
  • Length-of-stay and treatment intensity: Patient-days on dialysis drive consumption rates.
  • Clinical protocol standardization: Once a hospital standardizes a specific dextrose strength and container format, switching creates administrative friction.

Demand headwinds

  • Protocol shifts: Facilities may adjust dextrose concentrations based on metabolic targets or new clinical pathways.
  • Competition across solution formats: Equivalent offerings can win through pricing, availability, or contract leverage.
  • Regulatory or labeling interruptions: If product labeling changes require re-training or update order sets, short-term volume volatility can occur.

Who are the competitive substitutes for DIALYTE LM/ DEXTROSE 1.5% in plastic container?

Direct answer: The competitive set is other dialysis solutions with comparable dextrose concentration and compatible container format used in dialysis workflows. Competition is usually won through contract pricing, supply reliability, and pharmacy compatibility rather than differentiation claims.

Substitution pressure points

  • Therapeutic equivalence: If the dextrose concentration and intended clinical use are considered interchangeable within facility protocols, substitution can occur quickly through purchasing channels.
  • Formulation and container differences: Even when clinical chemistry targets are similar, deviations in container material or handling can create operational barriers.
  • Availability: If a competing product is consistently in-stock, it can displace the incumbent at the procurement level.

What does the financial trajectory typically look like for a dialysis solution product?

Direct answer: The financial trajectory for dialysis solutions usually follows utilization growth (patient-days) with periodic step-changes during contracting cycles and supply disruptions. Growth is rarely “brand-driven”; it is contract- and channel-driven.

Typical trajectory components

  • Revenue stability baseline: Hospital purchasing makes recurring volume more stable than specialty drugs sold in outpatient settings.
  • Volatility events: Shortages, manufacturing downtime, or contract renegotiations can create step-down or step-up periods.
  • Margin structure: Net price is squeezed by GPO terms, and margins are sensitive to freight, conversion costs, and credit/chargeback structures at wholesaler and channel levels.

What matters most financially

  • Contract coverage breadth: More covered accounts usually means smoother revenue.
  • Fill rate and on-time delivery: Dialysis units cannot pause treatments. Product availability can determine whether an incumbent retains formulary status.
  • Inventory management: Excess inventory can lead to inventory write-down risk or price concessions.

What is the FDA regulatory status and what does it mean for market continuity?

Direct answer: Dialysis solutions are regulated as drug products and must maintain consistent labeling and manufacturing controls for continued market access. Regulatory stability reduces switching risk because hospitals rely on label continuity for protocol order sets.

Regulatory status implications for commercial stability

  • Change control events (labeling revisions, manufacturing updates, container/closure changes) can slow re-ordering temporarily.
  • Lot release performance affects availability and distributor fill rates, which in turn influences contracting.

What is the Orange Book status of DIALYTE LM/ DEXTROSE 1.5% in plastic container?

Direct answer: Cannot be determined from the information provided. No Orange Book listing data for this exact product and configuration is included here, so a definitive status cannot be stated.


How strong is the patent estate for DIALYTE LM/ DEXTROSE 1.5%?

Direct answer: Cannot be determined from the information provided. No patent numbers, assignees, or expiration dates for this exact product configuration are included here, so a strength assessment cannot be produced.


When do key exclusivity barriers fall, and how does that affect generic or supplier switching risk?

Direct answer: Cannot be determined from the information provided. No FDA exclusivity or patent expiration timeline for this specific product and configuration is included here.


How does a generic entry or supplier switching scenario typically play out for dialysis solutions?

Direct answer: Switching risk is concentrated around (1) contract cycle windows, (2) supply continuity events, and (3) label or protocol compatibility. When switching is feasible, it occurs first through procurement and pharmacy ordering, then spreads across units within a health system.

Typical “switch mechanics” in hospitals

  • Formulary and contract update first: Pharmacy procurement changes drive purchase orders.
  • Protocol alignment and education: Renal team must align order sets and workflow steps.
  • Inventory transition: Facilities use existing inventory depletion windows, which delays full replacement.

Which companies typically control channel power for dialysis solutions?

Direct answer: Channel power typically sits with GPOs and large distributors that steer contracting and inventory. Product-specific distributors can influence realized pricing through service levels and fill reliability.

Commercial power map (how the market usually works)

  • GPO contracting: Determines baseline net pricing and preferred supplier status.
  • Large wholesalers: Influence distribution reach, delivery timelines, and account coverage.
  • IDNs and renal specialty chains: Can exert countervailing power through multi-site volume aggregation.

What manufacturing and supply-chain risks affect financial performance?

Direct answer: Supply constraints and manufacturing consistency are central to financial outcomes for dialysis solutions, because treatment continuity is non-negotiable.

Risk channels that move revenue

  • Raw material availability (dextrose supply and chemical inputs)
  • Container procurement (plastic container availability and QA release performance)
  • Filling line throughput (capacity limits drive allocation and backorders)
  • QA release timing (delayed release affects distributor availability)

How does DIALYTE LM / dextrose 1.5% compare with other dextrose strengths in the same dialysis category?

Direct answer: The comparison usually reduces to (1) dextrose strength protocol fit, (2) procurement contract position, and (3) availability. Higher utilization strengths can command better contract leverage simply due to demand volume.

Comparative business effects

  • Protocol-specific demand: Facilities may use multiple strengths but favor the one most aligned to their standard targets.
  • Switchability: If a hospital uses only one or two strengths, switching between them can be administratively slower.
  • Allocation sensitivity: In supply shortages, demand for constrained strengths can rise while others are substituted or deprioritized.

What revenue exposure and margin risks exist for this product class?

Direct answer: The biggest exposure is contract pricing pressure and supply substitution risk. Margin risk comes from channel economics and operational costs needed to maintain consistent lot release and fill rates.

Margin risk list

  • Distributor/wholesaler terms
  • GPO rebates or administrative fees
  • Freight and cold-chain or storage constraints (if applicable by labeling and logistics)
  • Cost inflation in plastic containers and chemical inputs
  • Write-offs from excess inventory if demand declines after protocol changes

Key Takeaways

  • DIALYTE LM/ DEXTROSE 1.5% in plastic container is a dialysis workflow input where demand is driven mainly by patient-days and institutional protocol standardization.
  • Revenue trajectory is largely contract and channel driven, with utilization providing the baseline and renewals plus supply events creating step changes.
  • Pricing is institutionally negotiated; net revenue depends on GPO and distributor economics, not retail dynamics.
  • Financial performance is sensitive to manufacturing consistency, lot release timing, and substitution feasibility across comparable dextrose solutions and container formats.
  • Patent/exclusivity/Orange Book status and generic entry timing cannot be concluded from the provided information.

FAQs

1) What hospital departments typically purchase DIALYTE LM/ DEXTROSE 1.5% in plastic container?
Renal therapy units and hospital pharmacy procurement teams through GPO/IDN contracting pathways.

2) Does dextrose strength (1.5%) affect contract priority versus other dextrose concentrations?
Yes, dextrose strength aligns with protocol order sets, which affects standardized purchasing volume.

3) What events most often cause switching away from a dialysis solution supplier?
Contract renegotiations, supply shortages, and protocol updates that change allowable equivalent substitutions.

4) How do supply disruptions translate into revenue impact for dialysis solutions?
They trigger allocation limits, lost fill rates, and potential displacement at the procurement level if alternative suppliers are consistently available.

5) What supply-chain factors are most likely to delay dialysis solution availability?
Container supply constraints, filling line capacity, and QA/laboratory lot release timing.


References (APA)

  1. U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling databases. FDA. https://www.fda.gov/
  2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
  3. FDA. (n.d.). Drug Shortages. https://www.fda.gov/drugs/drug-shortages

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