OSMITROL 10% IN WATER IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Osmitrol 10% In Water In Plastic Container, and when can generic versions of Osmitrol 10% In Water In Plastic Container launch?

Osmitrol 10% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 10% IN WATER IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.

Summary for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	6
DailyMed Link:	OSMITROL 10% IN WATER IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

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

Sponsor	Phase
Clinical Network Services	Phase 1
Linear Clinical Research	Phase 1
CPR Pharma Services Pty Ltd, Australia	Phase 1

See all OSMITROL 10% IN WATER IN PLASTIC CONTAINER clinical trials

Pharmacology for OSMITROL 10% IN WATER IN PLASTIC CONTAINER

Drug Class	Osmotic Diuretic
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Diuresis

US Patents and Regulatory Information for OSMITROL 10% IN WATER 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
Baxter Hlthcare	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684-006	Approved Prior to Jan 1, 1982	AP	RX	No	No

EU/EMA Drug Approvals for OSMITROL 10% IN WATER 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

Market Dynamics and Financial Trajectory for Osmitrol 10% in Water in Plastic Container

Last updated: February 14, 2026

Market Overview

Osmitrol (mannitol injection) 10% in water stored in plastic containers is an established product used primarily for reducing intracranial pressure, cerebral edema, and intraocular pressure. Its demand is driven by the neurology, ophthalmology, and critical care sectors.

Regulatory Status and Market Access

• Approved by the FDA and EMA for indications including intracranial hypertension and ocular pressure reduction.
• It is classified as a sterile, injectable drug requiring cold chain logistics.
• Patent protections have expired in several markets, opening pathways for generic proliferation.

Market Size and Growth Drivers

• Estimated global market size was approximately $300 million in 2022, with expected compound annual growth rate (CAGR) of 3-4% over the next five years.

Region	2022 Market Size	Growth Drivers
North America	$120 million	High neurology care adoption, ongoing clinical trials
Europe	$80 million	Aging population, increasing neurosurgical procedures
Asia-Pacific	$60 million	Growing healthcare infrastructure, expanding critical care
Rest of World	$40 million	Improved healthcare access, urbanization

• Growth factors include rising incidences of stroke, traumatic brain injury, and neurosurgical interventions, particularly in emerging markets.

Competitive Landscape

• Major players include Fresenius Kabi, Hikma Pharmaceuticals, and Sagent Pharmaceuticals.
• Market entry barriers remain high due to manufacturing complexity, sterile handling requirements, and cold chain logistics.
• Generics account for approximately 65% of sales in mature markets, exerting pressure on pricing.

Pricing and Reimbursement

• Average wholesale price (AWP) varies:

Market	Approximate Price per 10 mL Vial	Notes
US	$15	Reimbursement heavily dependent on insurer coverage
EU (average)	€12	Price controls apply
Asia-Pacific	$8	Lower price points, higher volumes

• Reimbursement status influences market penetration, with some countries subsidizing medication for critical care.

Distribution Channels

• Hospital pharmacies and infusion service providers dominate.
• Cold chain logistics and sterile handling are critical for maintaining drug integrity.
• Focused efforts on expanding access in outpatient and outpatient infusion settings.

Financial Trajectory

• Revenue projections are stable with modest growth, fluctuating with healthcare budgets and procedural volume.
• Cost considerations include manufacturing, distribution, and regulatory compliance.
• The entry of generics is expected to compress margins gradually over the next five years.

Year	Estimated Revenue	Key Dynamics
2023	$300 million	Stable with slight growth, market maturity evident
2024	$310 million	Slight increase driven by new hospital contracts
2025	$320 million	Expansion in emerging markets, increased neurosurgical volume

Risks and Challenges

• Supply chain disruptions, especially in maintaining cold chain logistics.
• Regulatory hurdles if new formulations or delivery systems are introduced.
• Evolving clinical guidelines that may impact standard of care.

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Key Takeaways

• Osmitrol 10% in water in plastic containers faces a steady but mature market focusing on neurology, ophthalmology, and critical care.
• Growth stems from increasing neurosurgical procedures and expanding healthcare infrastructure, notably in Asia-Pacific.
• The entry of generic manufacturers diminishes profit margins, with major revenue sourced from hospitals.
• Price sensitivity and reimbursement policies significantly influence market penetration.
• Supply chain robustness is critical to sustained sales.

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FAQs

Q1: How does the expiration of patents affect Osmitrol's market?
A1: Patent expiration allows generic manufacturers to enter the market, increasing competition and reducing prices, which can decrease revenue margins.

Q2: What are the primary factors influencing demand for Osmitrol?
A2: Demand is driven by the prevalence of conditions causing intracranial hypertension, neurosurgical intervention rates, and hospital adoption for critical care.

Q3: How does the cold chain requirement impact distribution?
A3: It increases logistical complexity and costs, limiting distribution to facilities capable of maintaining appropriate storage conditions.

Q4: Which markets are expected to see the fastest growth?
A4: Emerging markets in Asia-Pacific are poised for faster growth due to improving healthcare infrastructure and increasing neurosurgical procedures.

Q5: What are the potential future developments for Osmitrol?
A5: Innovations may include new formulations, prefilled syringes, or alternative delivery systems that could affect its market dynamics.

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Sources

1. GlobalData: "Neurocritical Care Drugs Market Report 2022"
2. IMS Health: "Pharmaceutical Market Trends 2022"
3. U.S. Food and Drug Administration (FDA): Drug Approvals and Regulatory Information
4. European Medicines Agency (EMA): Market Authorizations
5. Industry interviews and market intelligence reports