DEXTROSE 38.5% IN PLASTIC CONTAINER Drug Patent Profile

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Which patents cover Dextrose 38.5% In Plastic Container, and what generic alternatives are available?

Dextrose 38.5% In Plastic Container is a drug marketed by Abbott and is included in one NDA.

The generic ingredient in DEXTROSE 38.5% IN PLASTIC CONTAINER is dextrose. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the dextrose profile page.

Summary for DEXTROSE 38.5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	16
DailyMed Link:	DEXTROSE 38.5% IN PLASTIC CONTAINER at DailyMed

US Patents and Regulatory Information for DEXTROSE 38.5% 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
Abbott	DEXTROSE 38.5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	018923-001	Sep 19, 1984		DISCN	No	No

Last updated: June 25, 2026

DEXTROSE 38.5% IN PLASTIC CONTAINER market dynamics and financial trajectory

Executive summary: Dextrose 38.5% in plastic container is a high-concentration intravenous dextrose product tied to hospital use, compounding protocols, and acute-care formularies rather than branded “drug-like” demand. Financial trajectory is driven by (1) hospital contracting and group purchasing organization (GPO) pricing, (2) substitution risk from alternative dextrose strengths and delivery formats, (3) supply continuity costs for a concentrated, viscosity-sensitive solution, and (4) regulatory and quality execution that limits price competition when shortages occur. In practice, the product behaves like a specialty generics/“off-patent sterile injectables” line item where margin profile depends on supply chain scale, inspection outcomes, and competitive intensity.

How does dextrose 38.5% in plastic container market demand form in hospitals?

Featured snippet answer: Demand is primarily determined by inpatient acute-care protocols that use concentrated IV dextrose, hospital formularies, and conversion of patient-specific dosing needs into usable IV concentrations that minimize hyperglycemia risk.

What drives utilization

• Care setting: Intensive care, emergency departments, and inpatient units that manage hypoglycemia risk, transition feeding plans, or provide rapid glycemic stabilization.
• Protocol fit: Hospitals stock dextrose strengths and choose based on concentration, osmolarity tolerance, line access, and infusion compatibility.
• Dispensing model: Many health systems standardize on standardized IV product concentrations in pharmacy or at bedside. A 38.5% concentration is used when higher grams per mL are required.

What substitutes exist at the formulary level

• Other dextrose strengths: Hospitals can stock alternative concentrations and dilute or adjust infusion pumps per protocol.
• Delivery formats: Bags vs smaller containers, multi-dose vs single-use, and “plastic container” vs alternative packaging influence handling, leak risk, and compatibility workflows.
• Compounding and alternatives: Some institutions compound from lower strengths; others avoid compounding for sterility assurance.

Who buys dextrose 38.5% in plastic container and how does procurement affect pricing?

Featured snippet answer: Buyers are hospital pharmacy procurement teams and group purchasing organizations that negotiate contracted pricing, rebates, and substitution rules across therapeutic categories.

Contracting dynamics

• GPO leverage: Pricing is shaped by tiered contract structures and “effective price” formulas (contract price net of rebates).
• Switching friction: Products with identical clinical intent but different container sizes or concentration strengths can require protocol edits, which slows switching.
• Shortage management: When shortages occur, contracts can loosen and hospitals may accept higher spot-market pricing.

Pricing mechanics that dominate the P&L

• Net price vs list price: Net revenue depends on rebate and chargeback terms, not headline invoice prices.
• Freight and logistics: Concentrated IV solutions increase transport cost per therapeutic unit; damaged-container incidence is a cost driver.
• Yield and batch performance: Sterile manufacturing yields directly affect cost of goods sold (COGS) for small-molecule injectables with high unit costs per liter.

What is the competitive landscape for Dextrose 38.5% sterile injections?

Featured snippet answer: Competition is typically between multiple generic/authorized manufacturers of high-concentration sterile dextrose, with pricing pressure that increases when more suppliers qualify supply continuously.

Competitive intensity signals to track

• Contract coverage: How many manufacturers are in the hospital formulary or GPO preferred tier.
• Availability: Ongoing supply reduces premium pricing; constrained supply supports temporary price increases.
• Inspection and quality: Sterile injectable markets price risk into contracts after FDA inspection outcomes, recalls, or consent decree activity.

Where competition shows up operationally

• Manufacturing footprint: Plants that run sterile lines at scale can compete on cost and supply reliability.
• Packaging differentiation: “Plastic container” configuration and container volume (not stated here) affect compatibility with administration sets and nursing workflows.

When does dextrose 38.5% face demand shocks from substitution or guideline changes?

Featured snippet answer: Demand can contract when hospitals standardize on different dextrose concentrations, reduce stock-keeping complexity, or change hypoglycemia treatment protocols to lower-concentration infusions with dilution workflows.

Substitution pathways that reduce volume

• Protocol simplification: Consolidating stock to fewer dextrose strengths reduces variety and can displace higher-concentration SKUs.
• Formulary tightening: Health systems may prefer products with fewer stability, compatibility, or infusion-limit concerns.
• Compounding controls: If compounding becomes more restricted, demand may shift toward commercially packaged alternatives rather than away. If compounding is allowed, higher concentration products can lose preference.

Demand resilience factors

• Acute-care necessity: Hypoglycemia management maintains a baseline requirement for dextrose products.
• Operational switching limits: Even when a substitute is clinically feasible, switching takes time due to protocol and training updates.

How does supply continuity affect revenue and profitability for concentrated dextrose IV?

Featured snippet answer: Revenue and gross margin track supply availability. Consistent supply supports volume stability and reduces emergency buying premiums, while outages shift demand to alternative strengths and can create lost contract share.

Manufacturing and supply chain drivers

• Sterile operations capacity: Sterile filtration/fill-finish constraints and line utilization affect fill volume.
• Container integrity: Plastic container handling, sealing verification, and leak rates influence rejection and scrap.
• Raw material procurement: Dextrose feedstock availability and quality specs can affect batch release timelines.

What shortages do to the financial trajectory

• Short term: Spot-market pricing and contract exception pricing can raise net revenue per unit during constrained periods.
• Medium term: If shortages drive permanent formulary switching to alternatives, volume recovery can be partial even after supply returns.

What regulatory factors affect the market dynamics and financial trajectory?

Featured snippet answer: Sterile injectable regulatory compliance, including CGMP execution, device/container integrity, and labeling accuracy, drives continued market access and influences competitive set and pricing power.

Key regulatory risk domains

• Sterility assurance: Environmental monitoring, aseptic processing validation, and batch record integrity.
• Container-closure integrity: Plastic container compatibility, seals, and extractables.
• Labeling and administration safety: Concentration accuracy and warnings for administration route and monitoring requirements.

How regulatory outcomes translate to financials

• Consent decrees and warning letters: Can remove a supplier from contracted demand.
• Recalls: Can shift hospital allocations and increase short-term costs for alternative procurement.

How do patents impact dextrose 38.5% in plastic container economics?

Featured snippet answer: Patent protection typically does not determine pricing power for a basic IV dextrose solution; value is mostly driven by manufacturing execution, supply reliability, and contracting.

What likely matters more than patents

• DMF and manufacturing rights: Authorized facilities and validated manufacturing processes control market access more than “drug substance patents.”
• Data exclusivity or 505(b)(2) pathways: If present for specific NDA-level labeling or container formats, those effects are usually time-bounded and format-specific.

What is the “financial trajectory” pattern for off-patent sterile IV dextrose products?

Featured snippet answer: The trajectory typically shows stable-to-declining unit margins with periodic volatility from supply disruptions and contract renegotiations.

Common lifecycle pattern

• Early competitor entry phase: Multiple manufacturers establish supply; margins compress.
• Consolidation phase: Plant failures, compliance issues, or capacity exits reduce the competitive set; margins rebound transiently.
• Normalization phase: As supply equalizes and contracts renew, net pricing drifts down.

Margin drivers to model for this SKU

• Net pricing per unit under contract tiers
• COGS per unit driven by fill-finish yield, labor, sterilization cycle time, and packaging cost
• Logistics reflecting density and transport claims
• Quality costs including deviations and batch rejection rate

How does FDA listing and Orange Book status affect market access?

Featured snippet answer: For dextrose solutions, the practical access mechanism is usually ANDA or other abbreviated pathways rather than an Orange Book-centric branded exclusivity story.

What to look for in listings (mechanics)

• NDC-to-manufacturer mapping: Identify active NDA/ANDA holders and whether multiple labelers compete on the same container presentation.
• Approval type: Determine whether it is held as an ANDA vs NDA and whether any exclusivity is tied to formulation, container, or manufacturing process.

What generic entry risks exist for dextrose 38.5% in plastic container?

Featured snippet answer: Generic risk is primarily supply-side (ability to qualify sterile manufacturing and meet container-closure specs) rather than IP litigation risk.

Barriers that slow entry

• Sterile line capability: Proving aseptic process control at scale.
• Stability and compatibility: Demonstrating shelf life and administration compatibility for the specific container configuration.
• Quality history: Recruiting and retaining GMP-compliant capacity in a niche SKU.

How does dextrose 38.5% usage translate into revenue exposure at company level?

Featured snippet answer: Revenue exposure is concentrated among manufacturers with broad sterile injectable portfolios that can cross-subsidize manufacturing overhead and absorb lot-level quality cost variability.

Exposure concentration channels

• Contract dependence: A limited number of major hospital systems can represent a large share of volume.
• SKU fragmentation: If the product is only one of many dextrose strengths, volume shifts between strengths can redistribute revenue across an asset base.
• Portfolio pricing power: Companies with multiple IV strengths can offer bundled contracts and stabilize margins.

What supply and pricing scenario analysis best explains near-term financial trajectory?

Featured snippet answer: Build three scenarios around (1) supply continuity, (2) contract renegotiation, and (3) competitive re-entry/exit.

Scenario table (directional)

Scenario	Supply condition	Contract pricing	Volume impact	Expected financial effect
Base	Stable	Mid-to-low contracted net price	Stable	Flat-to-slight margin pressure
Tight	Constrained	Higher net price, exceptions	Displacement risk to substitutes	Revenue up, margin mixed (quality and logistics costs)
Loose	Expanded supply	Lower net price	Volume may shift but total could rise	Revenue flat, margin down

How does this product compare with other IV dextrose strengths financially?

Featured snippet answer: Higher concentration SKUs typically experience similar contracting logic but can have higher unit costs and higher quality/regulatory sensitivity due to handling and administration safety constraints.

Comparative considerations

• Inventory optimization: Hospitals may prefer concentration that reduces infusion volume but increases cost; utilization can swing with protocol.
• Compatibility requirements: Higher concentration can require specific line access or monitoring, limiting substitution choices.

Key market and financial metrics to monitor for Dextrose 38.5% in plastic container

• NDC-level share by manufacturer (proxy: sales by labeler where available)
• Net price per unit under GPO contracts
• Hospital contract tier changes (preferred vs non-preferred)
• Fill-finish utilization rates at sterile facilities
• Recall/deviation frequency and batch rejection rates
• Lead times and backorder volumes
• Utilization shift between dextrose strengths across health systems

Key Takeaways

• Market demand is hospital-driven and shaped by inpatient protocols and formulary switching dynamics more than IP exclusivity.
• Financial trajectory is primarily a function of net contracting price, sterile supply continuity, and quality execution for a concentrated sterile IV product.
• Competitive intensity tends to compress margins when supply normalizes, while shortages can lift net revenue temporarily but can also cause lasting formulary displacement to substitute strengths.
• Patent-driven economics are usually limited for basic IV dextrose; supply-side qualification and manufacturing reliability dominate entry barriers and market access.

FAQs

1. How do GPO contract tiers change net pricing for IV dextrose solutions?
2. What operational indicators best predict upcoming shortages for high-concentration sterile injectables?
3. How do hospitals decide whether to use 38.5% dextrose versus lower strengths with dilution?
4. What container-closure integrity issues most commonly impact sterile plastic IV dextrose products?
5. How does a manufacturer’s sterile facility inspection history affect hospital contracting outcomes for dextrose injectables?

References

1. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
2. FDA. Drug Shortages. U.S. Food and Drug Administration.
3. FDA. Current Good Manufacturing Practice (CGMP) Regulations. U.S. Food and Drug Administration.