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Last Updated: December 23, 2024

OSMITROL 5% IN WATER Drug Patent Profile


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When do Osmitrol 5% In Water patents expire, and what generic alternatives are available?

Osmitrol 5% In Water is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 5% IN WATER is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for OSMITROL 5% IN WATER
Drug patent expirations by year for OSMITROL 5% IN WATER
Recent Clinical Trials for OSMITROL 5% IN WATER

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

SponsorPhase
Linear Clinical ResearchPhase 1
CPR Pharma Services Pty Ltd, AustraliaPhase 1
Celtaxsys, Inc.Phase 1

See all OSMITROL 5% IN WATER clinical trials

Pharmacology for OSMITROL 5% IN WATER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for OSMITROL 5% IN WATER

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 5% IN WATER mannitol INJECTABLE;INJECTION 013684-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare OSMITROL 5% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-005 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 OSMITROL 5% IN WATER

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252
Bronchitol 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

OSMITROL 5% IN WATER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OSMITROL 5% in Water

Introduction to OSMITROL

OSMITROL, a solution of mannitol, is an osmotic diuretic used in various medical applications, including the promotion of diuresis, prevention and treatment of acute renal failure, reduction of intracranial and intraocular pressure, and other clinical indications[2][3][5].

Market Overview

The market for osmotic diuretics like OSMITROL is influenced by several factors, including the prevalence of conditions requiring diuretic therapy, advancements in medical technology, regulatory environments, and the competitive landscape.

Prevalence of Conditions

Conditions such as acute renal failure, cerebral edema, and elevated intraocular pressure are significant drivers for the demand of OSMITROL. The increasing incidence of these conditions, particularly in aging populations and those with chronic diseases, contributes to the steady demand for osmotic diuretics[3].

Advancements in Medical Technology

While OSMITROL itself is a well-established medication, advancements in delivery systems and monitoring technologies can impact its usage. For instance, improvements in IV administration systems and better monitoring tools for fluid and electrolyte balances can enhance the safety and efficacy of OSMITROL[2].

Regulatory Environment

Regulatory approvals and guidelines play a crucial role in the market dynamics of pharmaceuticals. OSMITROL, being a widely used medication, is subject to stringent regulatory oversight. Any changes in regulatory requirements or safety guidelines can affect its market trajectory[3][5].

Competitive Landscape

The market for osmotic diuretics is relatively niche but competitive. Other osmotic diuretics and alternative treatments for the same conditions can influence the market share of OSMITROL. However, its established reputation and broad clinical indications help maintain its position in the market[2].

Financial Trajectory

The financial performance of OSMITROL 5% in water can be analyzed through several key metrics.

Revenue Trends

Historically, OSMITROL has generated stable revenue due to its consistent demand in clinical settings. The revenue is influenced by the volume of sales, pricing strategies, and market competition. Given its essential role in critical care and emergency medicine, the revenue trend for OSMITROL is generally stable with potential for growth driven by increasing healthcare needs[3].

Cost Structure

The cost structure for OSMITROL includes manufacturing costs, research and development expenses, marketing expenditures, and regulatory compliance costs. The use of specialized containers, such as those made from polyvinyl chloride (PVC), and the need for strict quality control add to the production costs. However, economies of scale and long-term contracts with healthcare providers can help manage these costs[2][3].

Pricing Strategies

Pricing for OSMITROL is influenced by regulatory approvals, market competition, and the value it brings to patients and healthcare providers. Given its critical role in life-saving situations, the pricing is generally stable, although it can be subject to fluctuations based on market dynamics and regulatory changes.

Profit Margins

The profit margins for OSMITROL are typically moderate, reflecting the balance between the need to maintain affordability for healthcare providers and the necessity to cover production and research costs. Companies like Baxter Healthcare, which manufacture OSMITROL, aim to balance profitability with the ethical obligation to provide essential medications at reasonable prices[2].

Risk Factors and Challenges

Several risk factors and challenges can impact the financial trajectory of OSMITROL.

Renal Complications and Safety Concerns

OSMITROL is associated with renal complications, including the risk of renal failure, especially in patients with pre-existing renal disease. These risks necessitate careful monitoring and can lead to additional healthcare costs and potential legal liabilities[4].

Fluid and Electrolyte Imbalances

The administration of OSMITROL can cause fluid and electrolyte imbalances, which if not managed properly, can lead to severe and potentially fatal outcomes. This requires continuous monitoring and can add to the overall cost of care[3][4].

Regulatory Changes

Changes in regulatory requirements or safety guidelines can significantly impact the market dynamics and financial performance of OSMITROL. For example, stricter safety protocols or new labeling requirements can increase compliance costs and potentially affect sales[3][5].

Market Opportunities

Despite the challenges, there are several opportunities that can drive the growth and financial performance of OSMITROL.

Expanding Clinical Indications

Research into new clinical indications for OSMITROL can expand its market. For instance, its use in neurosurgery and ophthalmology presents opportunities for growth[2].

Global Market Expansion

Entering new markets, particularly in regions with growing healthcare needs, can increase the revenue base for OSMITROL. This requires strategic partnerships and compliance with local regulatory requirements[3].

Improvements in Delivery Systems

Advancements in IV administration systems and monitoring technologies can enhance the safety and efficacy of OSMITROL, making it more attractive to healthcare providers and potentially increasing its market share[2].

Key Takeaways

  • Stable Demand: OSMITROL has a stable demand driven by its critical role in various medical conditions.
  • Regulatory Oversight: The medication is subject to stringent regulatory requirements, which can impact its market dynamics.
  • Risk Management: Careful monitoring of renal function and fluid/electrolyte balances is crucial to mitigate risks associated with OSMITROL.
  • Market Expansion: Opportunities exist for expanding clinical indications and entering new global markets.
  • Technological Advancements: Improvements in delivery systems and monitoring technologies can enhance the safety and efficacy of OSMITROL.

FAQs

What are the primary indications for OSMITROL?

OSMITROL is indicated for the promotion of diuresis, prevention and treatment of acute renal failure, reduction of intracranial and intraocular pressure, and other clinical indications[2][3][5].

What are the potential risks associated with OSMITROL administration?

Potential risks include renal complications, fluid and electrolyte imbalances, hyperosmolarity, and other adverse reactions such as dehydration, hemoconcentration, and cardiac decompensation[3][4].

How is OSMITROL administered?

OSMITROL is administered intravenously as a sterile, nonpyrogenic solution. The concentration and volume depend on the specific clinical indication and patient needs[2][3].

What are the key factors influencing the market dynamics of OSMITROL?

Key factors include the prevalence of conditions requiring diuretic therapy, advancements in medical technology, regulatory environment, and competitive landscape[2][3].

Can OSMITROL be used in patients with renal impairment?

OSMITROL should be used with caution in patients with renal impairment. Close monitoring of renal function is necessary, and concomitant administration of nephrotoxic drugs should be avoided if possible[3][4].

Cited Sources

  1. NEW ZEALAND DATA SHEET - Medsafe[1]
  2. OSMITROL INJECTION - Baxter[2]
  3. OSMITROL safely and effectively. - accessdata.fda.gov[3]
  4. Label: OSMITROL- mannitol injection, solution - DailyMed[4]
  5. OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov[5]

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