CLINICAL TRIALS PROFILE FOR MANNITOL 20% IN PLASTIC CONTAINER

All Clinical Trials for MANNITOL 20% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003062 ↗	Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00113854 ↗	Mannitol as Adjunct Therapy for Childhood Cerebral Malaria	Unknown status	Makerere University	Phase 3	2004-10-01	Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine, the current drug of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol, but as these were not randomized controlled trials it is difficult to evaluate their significance. This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time.
NCT00117182 ↗	Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD	Completed	Pharmaxis	Phase 2	2005-07-01	The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.

Clinical Trial Conditions for MANNITOL 20% IN PLASTIC CONTAINER

Condition Name

Condition Name for MANNITOL 20% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Traumatic Brain Injury	7

Condition MeSH

Condition MeSH for MANNITOL 20% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Cystic Fibrosis	10
Brain Neoplasms	10

Clinical Trial Locations for MANNITOL 20% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MANNITOL 20% IN PLASTIC CONTAINER
Location	Trials
United States	137
Canada	39
United Kingdom	35
Australia	34
Italy	21

Trials by US State

Trials by US State for MANNITOL 20% IN PLASTIC CONTAINER
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for MANNITOL 20% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MANNITOL 20% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	1
PHASE2	7

Clinical Trial Status

Clinical Trial Status for MANNITOL 20% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	137
Unknown status	27
Recruiting	23

Clinical Trial Sponsors for MANNITOL 20% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MANNITOL 20% IN PLASTIC CONTAINER
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
Ain Shams University	6

Sponsor Type

Sponsor Type for MANNITOL 20% IN PLASTIC CONTAINER
Sponsor	Trials
Other	387
Industry	64
NIH	17

Last updated: May 21, 2026

Mannitol 20% in Plastic Container Clinical Trials Update, Market Analysis, and Revenue Projection (2026-2036)

Executive summary: Mannitol 20% in plastic containers is a widely used intravenous osmotic diuretic and hyperosmolar agent. Because it is a commodity-like, off-patent product form (active ingredient mannītol) with broad manufacturing redundancy, near-term market outcomes are driven more by FDA/USP compliance, container format conversions, supply continuity, and hospital formulary contracting than by clinical-trial differentiation. No new, proprietary clinical-trial “update” can be mapped to a specific, novel mannitol 20% brand or to a single manufacturer without identifiable trial registrations tied to a defined drug product strength and container. Market projections therefore apply at the “market basket” level for IV mannitol 20% products and similar hyperosmolar therapies used in acute care settings, with volume growth anchored to hospital admissions, neurotrauma and ophthalmic procedures, and perioperative utilization.

Is there a current clinical trials update for IV mannitol 20% in plastic containers?

Short answer: A molecule-level clinical-trials “update” for mannitol exists sporadically in acute care and neurosurgical contexts, but attributing new trials specifically to “mannitol 20% in plastic container” requires product-specific study identifiers (listed drug, NDC, sponsor product name). Without that linkage, a drug-product clinical-trials update cannot be made accurately.

What trial types show up for mannitol use (not product-specific)

• Traumatic brain injury (TBI) and intracranial pressure management comparisons
• Ophthalmic and perioperative hyperosmolar protocols
• Acute kidney injury (AKI) adjuncts and osmotherapy studies
• Hyperosmolar therapy safety and dosing regimen studies

Why container format rarely drives trial enrollment

Clinical endpoints in osmotherapy trials generally track intracranial pressure, serum osmolality, electrolytes, renal biomarkers, and adverse events. Container format (plastic vs glass) is usually not a study variable, so a “20% in plastic container” label typically functions as a regulated product presentation rather than a mechanistic differentiator for clinical trials.

What patents protect mannitol 20% IV formulations in plastic containers?

Short answer: Mannitol itself is not expected to be patent-protected as a small molecule. Commercial protection, where present, typically comes from formulation-specific process patents, container/packaging-related manufacturing controls, and regulatory exclusivities tied to a specific NDA/ANDA reference listing.

How protection typically breaks down for commodity IV solutions

• Active ingredient patents: expired or near-expired historically
• Composition-of-matter patents: uncommon for mannitol since it is established
• Manufacturing-process patents: can exist for specific sterilization/lyophilization analogs, but for sterile IV solutions, process IP is often narrow
• Packaging and container engineering: can be protected but rarely blocks generic availability unless paired with regulatory exclusivities

Commercial implication

In practice, competition is usually price-led after the reference product is off exclusivity, with differentiation limited to:

• NDC assortment, container size standardization
• Supply reliability and lead-time
• Traceability and quality system performance
• Contracting terms with GPOs and IDNs

When does mannitol 20% in plastic container lose exclusivity?

Short answer: Exclusivity analysis for a specific brand requires the exact listed drug and approval pathway. For commodity presentations like IV mannitol, the practical result is that multiple approved products already exist, so “loss of exclusivity” for any one presentation is not a single gate controlling generic availability.

What determines effective exclusivity for this product category

• NDA exclusivities tied to a specific reference product label
• 505(b)(2) or ANDA-dependent reference status for a particular NDC
• Orange Book listings that may show method-of-manufacture or use patents rather than composition

What is the Orange Book status of mannitol 20% in plastic container products?

Short answer: Orange Book status is product-specific and must be pulled for the exact NDC/strength/container presentation. A category-level statement cannot be made without naming the listed drug and its patent codes.

What to look for in Orange Book entries

• Patent type: drug substance, drug product, method-of-use, or method-of-manufacture
• Expiration dates and listed claims scope
• Whether patents are “listed” but not “relevant” to a generic filing (common litigation posture)

What generic entry risks exist for mannitol 20% IV solutions?

Short answer: Patent risk is typically lower for mannitol as an active ingredient, but entry risk is higher on execution:

• sterile manufacturing capacity and batch release
• particle control and container-material compatibility
• shelf-life and stability data acceptance by purchasers
• quality deviations that trigger recalls or procurement holds

Regulatory and quality drivers of entry timing

• Chemistry, Manufacturing, and Controls (CMC) alignment for container integrity
• Endotoxin/sterility assurance methods
• Stability protocols for osmolarity, clarity, and preservative/impurity profiles

How strong is the patent estate for IV mannitol 20% products?

Short answer: For commodity IV solutions, the relevant “strength” is typically limited to narrow process, packaging, or specific labeled method-of-use claims, not to broad composition control.

What usually matters in strength assessments

• Remaining years to listed patent expiration (if any) for a given NDC
• Litigation history for the listed product family
• Whether patents cover only specific package sizes or concentrations
• Prior Paragraph IV patterns from other IV solution categories

How does mannitol 20% compare with alternative hyperosmolar therapies?

Short answer: In acute care, hyperosmolar options include hypertonic saline formulations and, depending on indication, other osmotherapy protocols. Mannitol’s market position is driven by:

• clinical familiarity and clinician preference
• perceived renal safety profile when used appropriately
• formulary placement and procurement contracts
• availability and total cost of therapy

Net effect on demand

Demand for mannitol is “procedure and protocol” linked:

• neurosurgery and neurocritical care
• perioperative osmotherapy
• indications where hypertonic saline is a substitute

What market drivers expand demand for IV mannitol 20%?

Short answer: The growth ceiling is anchored to acute care utilization, while the growth floor depends on supply continuity and hospital contracting.

Primary demand drivers

• neurotrauma admissions and ICU bed utilization
• neurosurgical procedure volumes
• perioperative protocols in ophthalmology and related services
• long-term hospital inventory replenishment cycles
• supply chain resilience for sterile IV solutions

Primary headwinds

• price competition from multiple approved equivalents
• GPO contract revisions shifting mix among hyperosmolar agents
• recall and quality events in the sterile IV sector
• reimbursement pressures driving lower average selling prices (ASPs)

What is the competitive landscape for mannitol 20% in IV plastic containers?

Short answer: Competition is typically dominated by established sterile injectables manufacturers with broad ANDA coverage and strong distribution reach. For commodity strengths like 20%, the competitive field is usually wide, with tender-based wins.

How competition plays out in hospitals

• IDN tenders and GPO contract renewal drive annual volume shares
• product substitution policies determine how easily alternatives replace a brand
• procurement favors:
  • consistent supply
  • packaging compatibility with administration sets
  • standard carton/labeling workflows

Market projection for mannitol 20% in plastic container (2026-2036)

Short answer: Without product-specific shipment/price data by NDC, projections must be stated as category-level ranges driven by utilization and price erosion typical of commodity sterile injectables. The most reliable forecast signal is the mix of:

• stable-to-growing acute care volumes
• ongoing unit price declines or stabilization through contract competition
• periodic manufacturing disruptions that temporarily boost pricing and backorders

Forecast framework (scenario-based, category-level)

Key variables:

• Volume growth: tied to hospital admissions and ICU utilization
• Price trajectory: tied to competitive tendering and generic mix
• Share shift risk: substitution toward hypertonic saline protocols in some settings

Base case (typical commodity pattern)

• Volume: modest growth (mid-single digits CAGR)
• Price: low-to-mid single digit annual decline or stabilization
• Result: low-to-mid single digit revenue CAGR

Downside case (strong substitution + aggressive contracting)

• Volume flat to low growth
• Price decline accelerates
• Result: near-zero to low single digit revenue growth

Upside case (protocol preference + supply stability benefits)

• Volume higher than peers due to contract awards
• Price stabilizes due to constrained supply or fewer disruptions
• Result: mid-single digit revenue growth

Revenue exposure for stakeholders

• Manufacturers: margin compression risk remains the dominant financial factor
• Distributors: inventory turns and backorder risk dominate logistics P&L
• Investors: focus on manufacturing uptime and quality-system performance rather than clinical differentiation

Commercial and regulatory watchlist for 2026-2030

• Sterile injectables quality events (recalls, warning letters, consent decrees) that reshape supply
• GPO contract outcomes that re-rank market share among approved equivalents
• Container/packaging standard updates that force label or packaging-line changes
• Hyperosmolar protocol guideline updates affecting substitution patterns

Key Takeaways

• Mannitol 20% in plastic containers is a commodity-like sterile injectable where clinical differentiation is limited by product presentation and established mechanism.
• A product-specific “clinical trials update” cannot be responsibly mapped without direct trial registration linkage to the exact drug product presentation.
• Market performance is driven primarily by contracting, supply continuity, and competition from equivalents and substitutes (not by new proprietary clinical evidence).
• Revenue projections over 2026-2036 should be modeled as low-to-mid single digit CAGR in a base case, with strong sensitivity to price erosion and protocol substitution.

FAQs

1. Which NDCs typically drive hospital demand for IV mannitol 20% in plastic containers?
2. How do GPO tenders change mannitol 20% market share year over year?
3. What manufacturing quality events most often affect sterile IV solutions like mannitol 20%?
4. Do hypertonic saline protocols reduce mannitol utilization in neurocritical care settings?
5. What is the usual procurement lifecycle and inventory safety stock for commodity IV osmotherapy products?

References (APA)

No sources are cited because no product-specific clinical trials registry, FDA approvals/NDC-level Orange Book status, patent listings, or market/price data were provided in the prompt.