Last Updated: November 5, 2026

MANNITOL 20% IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Mannitol 20% In Plastic Container patents expire, and what generic alternatives are available?

Mannitol 20% In Plastic Container is a drug marketed by B Braun and Otsuka Icu Medcl and is included in two NDAs.

The generic ingredient in MANNITOL 20% IN PLASTIC CONTAINER is mannitol. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for MANNITOL 20% IN PLASTIC CONTAINER?
  • What are the global sales for MANNITOL 20% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for MANNITOL 20% IN PLASTIC CONTAINER?
Summary for MANNITOL 20% IN PLASTIC CONTAINER
Recent Clinical Trials for MANNITOL 20% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Xiangya Hospital of Central South UniversityPHASE4
Stanford UniversityPHASE1
Emmanuel CarreraPHASE2

See all MANNITOL 20% IN PLASTIC CONTAINER clinical trials

Pharmacology for MANNITOL 20% IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 20% 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 MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-004 Jul 26, 1993 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Otsuka Icu Medcl MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-004 Jan 8, 1990 AP RX 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

EU/EMA Drug Approvals for MANNITOL 20% IN PLASTIC CONTAINER

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care. Authorised no no no 2012-04-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal
Last updated: July 23, 2026

Mannitol 20% in Plastic Container Market Dynamics and Financial Trajectory: Pricing, Demand Drivers, and Competitive Outlook

Mannitol 20% in plastic containers is a mature, low-differentiation IV osmotic diuretic product used in indications such as elevated intracranial pressure and reduction of renal injury in certain settings. The market’s financial trajectory is shaped by: (1) generic supply intensity, (2) government and payer procurement pressure, (3) container and manufacturing compliance costs for sterile IV products, and (4) episodic demand shifts driven by hospital case mix and guideline adherence. Expect pricing to remain structurally pressured by multi-source competition, while unit volumes stay resilient but not high-growth.

What drives demand for mannitol 20% IV in plastic containers in hospitals?

Hospital demand for mannitol IV is tied to acute care pathways where osmotic diuresis is used, primarily in neurosurgical and neurocritical care workflows and select renal-protection protocols. In most systems, formularies treat IV mannitol as a standard product with limited room for differentiation, which keeps switching friction low once procurement contracts turn over.

Key demand drivers:

  • Neurocritical and perioperative use: Elevated intracranial pressure management and perioperative osmotherapy sustain recurring usage.
  • Renal-protection protocols: Some hospital pathways use mannitol in renal-risk settings, adding demand stability.
  • Hospital inventory dynamics: IV products with wide clinical familiarity are stocked broadly, which supports steady throughput even when day-to-day usage varies.
  • Clinical guideline consistency: Where mannitol is embedded in standard order sets, demand becomes less sensitive to competitor marketing.

Demand drag and volatility sources:

  • Clinical practice variability: Use frequency differs by ICU protocols and clinician preference relative to hypertonic saline approaches.
  • Formulary tightening: Payers and hospital pharmacy committees increasingly consolidate to contracted products and limit non-preferred options.
  • Supply interruptions: Sterile manufacturing constraints can cause short-term allocation, indirectly improving pricing for the available manufacturer.

How does hypertonic saline compete with mannitol in osmotherapy?

The competitive impact usually shows up through:

  • Protocol substitution: Some ICUs prefer hypertonic saline, reducing mannitol utilization in those institutions.
  • Procurement strategy: Hospitals may dual-source both agents but concentrate volumes across fewer SKUs once the contract is set.
  • Net effect: Hypertonic saline can cap mannitol growth even when absolute demand remains steady.

What are the market dynamics shaping pricing for mannitol 20% in plastic containers?

Mannitol 20% in plastic containers sits in a price-sensitive segment where cost structure and competition dominate pricing. The product is typically sourced through large hospital group purchasing organizations (GPOs) and direct contracting with wholesalers/distributors.

Pricing dynamics:

  • Multi-source generic competition: When multiple manufacturers supply the same strength and container type, wholesale acquisition cost (WAC) and net price compress toward low-margin levels.
  • Container and stability considerations: “In plastic container” can be a procurement-relevant spec. If procurement prefers plastic due to handling and supply chain considerations, manufacturers with qualifying products can hold share.
  • Regulatory and manufacturing overhead: Sterile IV manufacturing requires high compliance spend, but differentiation is limited, pushing manufacturers to compete on price and supply reliability.
  • Government and payer pressure: In tenders and managed contracts, price is a primary selection variable.
  • Wholesaler and distribution terms: Net realized pricing depends heavily on rebate and contract terms, not list price.

Is mannitol 20% priced like a high-volume hospital commodity or like a specialty IV?

It behaves like a commodity IV drug:

  • Contracting and allocation matter more than clinical differentiation.
  • Price variance is usually driven by manufacturing availability, supply chain normalization, and procurement concentration.

When does mannitol 20% see supply shocks, and how do they affect financial performance?

Supply shocks in sterile IV segments come from:

  • Batch failures or sterility assurance issues
  • Raw material constraints
  • Facility maintenance or compliance actions
  • Cold-chain or distribution limitations (less relevant than for biologics, but still a factor for handling)

Financial impact pattern:

  • Short-term price uplift when competitors are constrained.
  • Delayed normalization after new supply arrives.
  • Inventory rebalancing: after a shortage period, demand can dip as hospitals use existing stock and re-enter routine purchasing.

For a manufacturer, the volatility tends to show up first in:

  • Gross margin changes due to short-lived pricing power
  • Sales mix shift if only certain SKUs are available

How has the financial trajectory of IV mannitol trended historically (volume vs price)?

The mature nature of IV osmotic diuretics typically yields:

  • Volume stability to modest growth driven by hospital admissions and critical care utilization
  • Price erosion over time due to generic entry and contract renegotiations

In mature generics:

  • Unit volume does not usually fall absent protocol substitution or formulary removal.
  • Net sales growth typically depends on staying contracted, maintaining supply continuity, and winning share from constrained rivals.

A realistic financial trajectory for an incumbent or steady supplier:

  1. Mid-term pricing pressure due to multi-source competition.
  2. Margin compression unless manufacturing scale and yield outperform.
  3. Revenue resilience due to baseline acute-care demand.

What patent and exclusivity landscape affects mannitol 20% pricing power?

For mannitol products, market dynamics are dominated by generic supply rather than active exclusivity. In most cases:

  • Active ingredient and strength combinations are long beyond meaningful patent-driven protection.
  • Any value comes from container-form factor qualification, manufacturing process improvements, and regulatory listing continuity, not composition-of-matter monopolies.

The net commercial implication:

  • Pricing is constrained by generic parity.
  • Competitive advantage comes from logistics, contract execution, and manufacturing uptime.

What does the competitive landscape look like for mannitol 20% in plastic containers?

Competition is usually structured as:

  • Multiple generic manufacturers supplying the same dosage strength and container type
  • Hospital contract winners that secure quarterly or annual preferred status
  • Distributor allocations during shortages that can temporarily redirect volume

Competitive factors that matter most:

  • Supply reliability: consistent deliveries prevent hospital switching away.
  • Packaging availability: plastic containers must meet procurement specifications.
  • Regulatory and inspection performance: avoids product holds and ensures continuous supply.
  • Cost position: sterilization, container filling, and QA yield drive competitiveness.

What are the key commercial risks for manufacturers in mannitol 20% IV?

Principal risks:

  • Margin squeeze: commoditized pricing erodes profitability unless scale and process yields are strong.
  • Contract concentration: a loss of a major GPO or hospital system contract can materially reduce volumes.
  • Supply interruptions: sterile manufacturing disruptions can cause revenue loss and permanent share shifts.
  • Protocol drift: hypertonic saline substitution can reduce mannitol usage in some ICUs, limiting growth.
  • Regulatory holds: manufacturing compliance issues can trigger withdrawals or temporary shortages.

How does container format (“plastic container”) affect market access and share?

Container format can influence:

  • Formulary acceptance: procurement specifications may explicitly prefer plastic container presentations.
  • Handling and administration preferences: staff experience and institutional protocols can favor one format.
  • Logistics: plastic containers can change shipping damage profiles and storage handling.

Commercial outcome:

  • If a manufacturer’s presentation aligns with procurement specs, it can win or retain contract share even without clinical differentiation.

What regulatory and FDA status elements typically govern this product class?

For mature IV drugs:

  • Manufacturing approvals and listing continuity dominate commercial stability.
  • Compliance with sterile drug manufacturing regulations and labeling requirements is essential to avoid product interruptions.

Practical consequence:

  • Market access is maintained through consistent GMP performance and ongoing FDA listing, not through new clinical evidence.

What generic entry risks exist, and how do they affect future pricing?

Because this is a mature product:

  • New entry typically comes from manufacturers adding supply capacity rather than from breakthrough science.
  • Pricing typically trends downward when new supply reaches the market and contracts reset.

Generic entry risk translates into:

  • Higher supply and lower price after contract cycles.
  • Share gains for new entrants at the expense of incumbents if they secure early preferred status.

What litigation history usually matters for mannitol IV products?

For commodity IV generics:

  • Patent litigation is less central than in branded pharmaceuticals.
  • Commercial disputes are more likely to be contract, supply allocation, or manufacturing/quality issues rather than active IP infringement.

Where IP exists historically, it usually affects earlier market development rather than current pricing power.

What revenue exposure should investors or licensors model for mannitol 20%?

Revenue exposure modeling should prioritize:

  • Contract renewal timing: major pricing resets occur at contract renegotiations.
  • Supply uptime: manufacturing interruptions directly reduce sellable volume.
  • Mix shift: container and package size can change realized pricing.
  • Customer concentration: hospital systems and GPOs can account for outsized share.

Typical revenue sensitivity:

  • Price: high sensitivity due to commoditization
  • Volume: moderate sensitivity given acute-care baseline demand
  • Supply: high sensitivity because shortages and allocations can swing volumes quickly

Key commercial trajectory outlook for the next 3–5 years

Base-case trajectory for mannitol 20% in plastic containers:

  • Net sales: stable to low growth, driven by hospital case mix and contract wins
  • Net pricing: continued downward pressure, especially around contract cycles and periods of increased supply
  • Margin: constrained unless a manufacturer has superior cost position and manufacturing continuity
  • Risk events: supply disruptions can temporarily improve margins but are not durable without structural constraints

Key Takeaways

  • Mannitol 20% IV in plastic containers is a commodity-like acute-care IV with resilient baseline demand but structurally pressured pricing.
  • Financial trajectory is driven more by contract pricing, supply continuity, and manufacturing cost position than by exclusivity or innovation.
  • Volume tends to remain steady; revenue growth, if any, usually comes from share gains and contract wins rather than price expansion.
  • The principal downside risks are contract loss, sterile manufacturing disruptions, and ICU protocol substitution toward hypertonic saline.

FAQs

1) What is the most common clinical use of mannitol 20% IV in hospitals?
Elevated intracranial pressure management and selected renal-protection/renal injury risk protocols in acute care settings.

2) Does mannitol 20% face strong uptake from hypertonic saline substitutions?
Protocol-driven substitution can reduce use in some ICU pathways, but many hospitals dual-source and maintain mannitol as part of osmotherapy options.

3) How do GPO and hospital contracting cycles typically affect net pricing?
They often trigger episodic price resets, pushing net pricing down when new supply is available and upward only during localized shortages.

4) What manufacturing factors most influence availability and realized revenue for sterile IV generics?
Sterility assurance, batch yield, QA release timelines, and facility uptime during filling and packaging operations.

5) What procurement spec can matter commercially for “plastic container” presentations?
Container format eligibility can determine whether a product is permitted in preferred formularies and contracting lanes, impacting share even among pharmacologically equivalent options.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.