CLINICAL TRIALS PROFILE FOR DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Dextrose 5% And Electrolyte No. 48 In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
New Dosage	NCT01533090 ↗	Evaluation of Reduced-volume PEG Bowel Preparation Administered the Same Day of Colonoscopy	Completed	Catholic University of the Sacred Heart	N/A	2010-04-01	The conventional total dose of 4 L of polyethylene glycol (PEG) given the day before the procedure is safe and effective. It has been the standard cleansing regimen for the last 25 years. To overcome the difficulty in completing the bowel preparation due to large volume and/or taste, reduced-volume (mixed) bowel preparation of bisacodyl and 2 L of PEG have been shown to provide adequate colon cleansing and better tolerability. LoVol-esse is a reduced-volume PEG-based bowel preparation to be used in combination with bisacodyl and designed to improve patient tolerability and attitude toward bowel cleansing prior to colonoscopy thanks to the reduced volume and improved taste. The present study is intended to compare the new dosing regimen of the bowel lavage solution given the same day compared with standard PEG formulation (SELG 1000) given the day before colonoscopy.

All Clinical Trials for Dextrose 5% And Electrolyte No. 48 In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001986 ↗	1-Octanol to Treat Essential Tremor	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2000-01-01	This study will evaluate the safety and effectiveness of the food additive 1-octanol for treating essential tremor. This disorder, which is an involuntary shaking, usually of the hands, has no satisfactory treatment. It affects more than one of every 100 people in the general population, with the figure climbing to nearly 4 in every hundred among people over 40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This study will test the effects of the accepted daily intake of 1-octanol (1 milligram per kilogram of body weight) on essential tremor in humans. Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid, liver and kidney problems. Participants will be randomly assigned to receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting blood samples during the study. Those in the 1-octanol group will be given a 1-octanol capsule; the placebo group will receive a look-alike capsule containing no active ingredient. Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study. Tremors will be measured once before the catheter is placed, every 15 minutes during the first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and once again after 5 hours. The tremors are measured using procedures called accelerometry and surface electromyography. For these procedures, electrodes are taped to the skin; needles are not used. Blood samples will be collected once before taking the capsule, every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5 hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate) will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30 minutes during the third hour, and again at 4 hours and 5 hours. Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination, including a blood test.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	University of Texas	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00039988 ↗	Treatment of Multiple Sclerosis With Copaxone and Albuterol	Completed	Autoimmunity Centers of Excellence	N/A	2001-11-01	The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.

Clinical Trial Conditions for Dextrose 5% And Electrolyte No. 48 In Plastic Container

Condition Name

Condition Name for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Intervention	Trials
Postoperative Nausea and Vomiting	12
Heart Failure	12
Colonoscopy	12
Hepatic Encephalopathy	9

Condition MeSH

Condition MeSH for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Intervention	Trials
Heart Failure	24
Vomiting	19
Fibrosis	16
Postoperative Nausea and Vomiting	16

Clinical Trial Locations for Dextrose 5% And Electrolyte No. 48 In Plastic Container

Trials by Country

Trials by Country for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Location	Trials
United States	310
China	68
Canada	32
Egypt	29
Mexico	26

Trials by US State

Trials by US State for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Location	Trials
Texas	22
Ohio	18
Pennsylvania	17
New York	15
Illinois	14

Clinical Trial Progress for Dextrose 5% And Electrolyte No. 48 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Clinical Trial Phase	Trials
PHASE4	19
PHASE3	7
PHASE2	11

Clinical Trial Status

Clinical Trial Status for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Clinical Trial Phase	Trials
Completed	170
Recruiting	85
Unknown status	45

Clinical Trial Sponsors for Dextrose 5% And Electrolyte No. 48 In Plastic Container

Sponsor Name

Sponsor Name for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Sponsor	Trials
Assiut University	7
The Hospital for Sick Children	6
Takeda	6

Sponsor Type

Sponsor Type for Dextrose 5% And Electrolyte No. 48 In Plastic Container
Sponsor	Trials
Other	495
Industry	103
NIH	16

Last updated: May 12, 2026

Dextrose 5% and Electrolyte No. 48 in Plastic Container: Clinical Trials Update, Market Size, and Forecast (2024–2034)

Executive summary

• Product type: Non-oncology, sterile intravenous (IV) parenteral nutrition–adjacent solution (dextrose 5% with electrolytes), supplied as a ready-to-use plastic container infusion.
• Clinical trial visibility: The specific branded/configured product “Dextrose 5% and Electrolyte No. 48 in Plastic Container” has no material publicly indexed interventional trial footprint distinct from the broader “IV dextrose + electrolytes” category; use is typically governed by hospital formularies and compendial compatibility rather than disease-specific registrational trials.
• Market structure: Sales are driven by hospital and alternate-care facility procurement, formulary adoption, and contracting with group purchasing organizations (GPOs), with supply continuity and container compatibility as key buying criteria.
• Forecast drivers (2024–2034): aging demographics, rising inpatient acuity, increased reliance on IV fluids for dehydration/electrolyte management, and continued substitution toward safer handling and storage (plastic container logistics).
• Competitive set: Generally, the relevant competition is generic/manufacturer-equivalent IV solutions (same strength, same electrolyte content) rather than differentiated branded products. Lead-time and sterile manufacturing capacity determine availability.
• Core risk: product-specific availability shocks tied to raw material, container supply, and manufacturing site performance.

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Are there clinical trials for Dextrose 5% and Electrolyte No. 48 in plastic container?

Short answer: The product is used as a standard IV electrolyte solution, with clinical evidence typically residing at the level of IV fluid therapy and electrolyte correction frameworks, not as registrational trials for this exact formulation in a plastic container.

What usually counts as “clinical trials” for IV electrolyte dextrose solutions

Interventional trials most often exist in adjacent buckets:

• Dextrose-containing IV fluids vs. alternatives (e.g., isotonic crystalloids, balanced solutions, saline vs dextrose mixtures).
• Electrolyte correction protocols (sodium, potassium, phosphate, magnesium) across inpatient settings.
• Safety studies focused on stability, compatibility, sterility, and adverse event surveillance rather than efficacy in a narrow indication.

Product-specific trial footprint: why it is typically low

For an established compendial IV fluid:

• Manufacturers usually do not run brand-level trials because endpoints are not disease-specific.
• Regulatory positioning often treats the product as a simple formulation where equivalence and sterility/labeling drive approvals.
• Hospitals and clinicians treat it as a component of routine care pathways.

Implication for pipeline reads: clinical trial “updates” for this exact formulation usually do not exist as a discrete pipeline event; market changes come from procurement, availability, and label/packaging changes, not from FDA approvals tied to disease indication expansion.

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What is the FDA regulatory status of dextrose 5% and electrolyte no. 48 in plastic container?

Short answer: The product is regulated as a sterile drug product for IV infusion. For hospital fluids, the regulatory focus is CMC, sterility assurance, container integrity, and labeling.

Regulatory category and review themes that matter commercially

For IV electrolyte solutions, key FDA review points typically include:

• Sterile manufacturing and container closure integrity
• Osmolality and compatibility expectations with common co-administered therapies
• Stability and shelf life in plastic container systems
• Labeling for administration routes and contraindications
• Human factors/handling elements for large-volume parenterals (LVPs)

Orange Book relevance

For simple, multi-source infusion solutions, presence in the FDA Orange Book is not always the main commercial “exclusivity clock,” because many entries behave like widely available generics or “equivalent” products rather than single-reference, long exclusivity families.

Commercial implication: market entry timing and share are often less about a single Orange Book exclusivity expiry and more about whether manufacturers can supply and whether hospitals contract with a given NDC.

(No actionable Orange Book NDC/patent dataset for this specific branded configuration is provided in the prompt, so no claim is made about listing status, reference product, or specific exclusivity dates.)

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When does exclusivity end for dextrose 5% and electrolyte no. 48 solutions?

Short answer: For widely supplied IV electrolyte/dextrose fluids, exclusivity is usually limited or not the primary barrier. Competitive supply tends to normalize quickly when manufacturing lines are online.

Why exclusivity “timing” is hard to map for this category

Even when a reference product has historical exclusivity, practical barriers often include:

• production capacity constraints
• container/sterile fill line qualification
• raw material sourcing
• hospital contracting cycles

Implication: forecasts should weight supply continuity and contracting more than patent calendars for category-level demand projections.

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How big is the market for dextrose plus electrolytes IV fluids, and what forecast applies to 2024–2034?

Short answer: The relevant market is the broader IV fluids (dextrose and electrolyte solutions) segment consumed in hospitals and alternate-care settings. Product-specific triangulation depends on total IV fluids volumes and the share of dextrose-electrolyte mixes.

Demand drivers

• Higher inpatient volume and longer stays drive IV fluid use.
• Dehydration and electrolyte correction needs remain persistent indications across ED, med-surg, ICU, and perioperative settings.
• Clinical emphasis on standardized order sets increases use of pre-mixed LVPs versus compounding.

Bottom-up supply chain reality that shapes revenue

Revenue forecasts for these fluids typically track:

• facility contracting and formulary placement
• reimbursement and drug spend management
• preference shifts between plastic container sizes and distribution formats
• unit dose count and average sales price (ASP) dynamics as multi-source supply increases

Projection framework (category-to-product translation)

Use a “category volume times product share” approach:

1. Total IV fluid consumption (hospital + post-acute)
2. Share of dextrose-containing regimens (vs isotonic crystalloids)
3. Share of pre-mixed electrolyte solutions (vs custom compounding)
4. Share of plastic container SKUs within the pre-mixed subgroup
5. ASP trend (multi-source normalization generally compresses ASP; inflation and transport costs may partially offset)

Forecast direction (2024–2034):

• Expect modest, steady growth driven by volume, offset in part by pricing pressure from multi-source competition.
• A supply disruption can cause short-term spikes in utilization and procurement cost, but not structural growth unless there is durable manufacturing concentration.

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Which companies manufacture and supply dextrose 5% plus electrolyte no. 48 IV solutions in plastic containers?

Short answer: The competitive landscape is usually multi-source: established IV fluid manufacturers, generic sterile injectables suppliers, and large LVP-capable CDMOs operating within hospital supply contracts.

Competitive “who matters” in hospital IV fluids

• LVP-capable sterile manufacturers with qualified plastic container systems
• companies with strong GPO contract coverage and distribution reach
• suppliers with documented supply reliability during shortages

What “winning” looks like

• formulary inclusion at health systems
• consistent NDC availability at forecastable lead times
• compliance with compatibility standards for common co-administered therapies

(No supplier roster is stated in the prompt, and no NDC-level mapping is provided; no company names are asserted.)

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What generic entry risks exist for this dextrose-electrolyte IV fluid?

Short answer: Generic entry is typically not constrained by patent thickets for these products; entry risk is more often CMC execution and sterile supply capacity.

Generic entry vectors

• “Equivalent” formulations from multiple manufacturers
• NDC expansions as manufacturing sites come online
• line relocations and packaging changes that reset supply patterns

Market-level risk signals

• sudden changes in availability or lead times at large distributors
• shifts in contracting toward fewer suppliers
• recalls or sterile process issues at upstream manufacturing sites

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How does this product compare with other dextrose-electrolyte IV regimens?

Short answer: The product’s differentiation is its electrolyte composition and ready-to-use plastic container configuration, which determine clinical suitability within standard order sets.

Key comparison axes for buyers

• electrolyte content alignment with hospital protocols
• compatibility with common infusion sets and co-administered drugs
• container format (size, handling ergonomics, labeling clarity)
• stability and shelf life under typical distribution practices

Clinical “fit” typically determines usage

Clinicians select based on:

• electrolyte needs (e.g., sodium, potassium, phosphate levels)
• patient risk (renal impairment, arrhythmia risk, fluid balance status)
• whether the fluid is a stopgap vs ongoing correction regimen

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What patent estate strength is there for dextrose 5% plus electrolyte no. 48 solutions?

Short answer: Patent estates for simple IV electrolyte solutions are typically less material than for small-molecule oncology drugs, because the products are widely manufactured and often positioned around equivalence and CMC.

How patents usually matter in this category

Where patents do matter, they tend to be tied to:

• specific formulations or concentration ranges
• container systems or stability improvements
• manufacturing processes and sterile filtration/fill improvements
• method-of-use claims for narrow clinical protocols

No specific patent numbers or assignee data can be provided because the prompt does not include the relevant reference product, NDC(s), or FDA Orange Book listing identifiers.

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What patent litigation affects IV dextrose-electrolyte solutions?

Short answer: Category-level litigation exists episodically, but there is no product-specific litigation record provided in the prompt that ties to “Dextrose 5% And Electrolyte No. 48 In Plastic Container.”

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What is the commercial outlook for hospitals and distributors using this IV solution?

Short answer: The outlook is driven by:

• contract pricing and multi-source competition
• supply reliability
• operational ease of storage and administration for plastic container LVPs

Procurement factors that affect utilization

• substitution policy for equivalent NDCs within the same electrolyte recipe
• nursing workflow and administration time
• pharmacy compounding avoidance policies favoring pre-mixed solutions
• distribution lead times and safety stock practices

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Key Takeaways

• This IV solution is treated as routine hospital therapy, with clinical evidence typically category-based rather than product-specific registrational trials.
• Market growth from 2024–2034 is likely steady and volume-led, with pricing pressure from multi-source supply.
• The decisive commercial variables are formularies, contracting, and supply continuity, not patent calendars.
• Product-specific exclusivity, Orange Book status, patent estate strength, and litigation cannot be quantified from the information provided in the prompt.

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FAQs

1. Does dextrose 5% plus electrolyte IV solution require therapeutic drug monitoring?
2. How do plastic container IV fluids change pharmacy storage and waste compared with glass?
3. What are the main clinical contraindications for dextrose-containing electrolyte infusions in renal or cardiac patients?
4. How do shortages of LVP container systems affect hospital IV fluid formularies and substitution?
5. What stability and compatibility tests determine whether an IV dextrose-electrolyte solution can be co-infused?

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA website).