OSMITROL 15% IN WATER IN PLASTIC CONTAINER Drug Patent Profile

When do Osmitrol 15% In Water In Plastic Container patents expire, and when can generic versions of Osmitrol 15% In Water In Plastic Container launch?

Osmitrol 15% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 15% 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 15% 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 15% IN WATER IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for OSMITROL 15% IN WATER IN PLASTIC CONTAINER

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

Sponsor	Phase
Celtaxsys, Inc.	Phase 1
Clinical Network Services	Phase 1
Linear Clinical Research	Phase 1

See all OSMITROL 15% IN WATER IN PLASTIC CONTAINER clinical trials

Pharmacology for OSMITROL 15% 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 15% 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 15% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684-008	Approved Prior to Jan 1, 1982	AP	RX	No	No

EU/EMA Drug Approvals for OSMITROL 15% 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 15% in Water in Plastic Container

Last updated: March 29, 2026

What is OSMITROL 15%?

OSMITROL 15% is an intravenous, hypertonic saline solution primarily used in managing hyponatremia, cerebral edema, and other electrolyte imbalances. It contains 15% sodium chloride dissolved in water, packaged in plastic containers for medical use.

Market Size and Growth

The global hypertonic saline market, estimated at approximately USD 750 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 7% through 2028. OSMITROL 15%, as a key product, captures a substantial part of this growth, driven by increasing hospitalizations for electrolyte-related conditions and a rising geriatric population susceptible to hyponatremia [1].

Forecasts suggest that the specific segment of 15% saline solutions will attain USD 200 million by 2028.

Market Drivers

Increasing Prevalence of Hyponatremia

Hyponatremia affects roughly 15-20% of hospitalized patients. The aging population, chronic illnesses, and rising incidences of neurological disorders escalate demand for hypertonic saline solutions [2].

Growth in Emergency and Critical Care

Hospitals increasingly incorporate hypertonic saline in ICU protocols for traumatic brain injury and cerebral edema management, boosting market volume.

Regulatory Approvals and Expanding Indications

Regulatory bodies like the FDA approve hypertonic saline for specific indications, influencing broader acceptance and utilization.

Competitive Landscape

Major Players

• Baxter International
• Fresenius Kabi
• B. Braun Melsungen AG
• Local and regional manufacturers

Key Differentiators

• Product formulation consistency
• Packaging innovations (plastic containers)
• Market reach and distribution networks

Challenges

• Price competition
• Strict regulatory compliance
• Supply chain disruptions

Manufacturing and Supply Chain Considerations

Optimizing production of OSMITROL 15% involves ensuring raw material quality, sterility standards, and efficient logistics. Increased demand may pressure manufacturing capacity, requiring capital investment or strategic partnerships.

Pricing Strategies and Revenue Projections

Average wholesale pricing for 15% saline solutions varies between USD 10-15 per 100 ml. With an estimated annual market volume of 13-15 million units globally, revenue potential exceeds USD 150 million annually.

Projected revenue for OSMITROL 15% specifically could reach USD 20-30 million in the next five years, assuming a 10-15% market share increase, driven by expanding hospital use and regional penetration.

Regulatory and Reimbursement Landscape

Product approval by agencies like the FDA or EMA directly impacts market access. Reimbursement policies for critical care drugs influence hospital purchasing decisions, affecting volume sales.

Key Risks

• Regulatory delays or restrictions
• Price sensitivity among healthcare providers
• Emerging generic competition

Investment Opportunities

Scaling manufacturing, improving supply chain resilience, and securing regulatory approvals in emerging markets offer growth avenues. Partnerships with healthcare providers strengthen distribution channels.

Key Takeaways

1. The global hypertonic saline market, especially 15% solutions, is expected to grow at 7% CAGR, reaching USD 200 million by 2028.
2. Demand is driven by the increasing prevalence of hyponatremia and neurological indications.
3. Market competition centers on product quality, packaging, and distribution, with key players including Baxter and Fresenius Kabi.
4. Revenue projections for OSMITROL 15% suggest potential annual sales of USD 20-30 million within five years.
5. Regulatory environment and reimbursement policies significantly impact market access and growth trajectory.

FAQs

Q1: What factors influence the pricing of OSMITROL 15% solutions?
Pricing depends on manufacturing costs, packaging, procurement volume, regional market conditions, and competitive dynamics.

Q2: How does regulatory approval affect the market potential?
Regulatory approval determines legal market access; delays or restrictions can limit sales and growth prospects.

Q3: What regional markets present the highest growth opportunities?
Emerging markets in Asia-Pacific and Latin America show increasing healthcare investments and unmet needs for electrolyte therapies.

Q4: How does supply chain resilience impact sales?
Disruptions can lead to shortages, delaying hospital procurement and reducing revenue. Strategic stockpiling and diversified sourcing mitigate risks.

Q5: What is the potential for generic competition for OSMITROL 15%?
Patent expirations and regulatory approvals may foster generic entries, pressuring pricing and market share.

---

References

[1] MarketsandMarkets. (2022). Hypertonic Saline Market by Product, Application, and Region.
[2] National Institutes of Health. (2021). Hyponatremia: pathophysiology, diagnosis, and management.