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Last Updated: December 23, 2024

OSMITROL 20% IN WATER IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Osmitrol 20% In Water In Plastic Container, and what generic alternatives are available?

Osmitrol 20% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 20% IN WATER IN PLASTIC CONTAINER 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 20% IN WATER IN PLASTIC CONTAINER
Drug patent expirations by year for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
Recent Clinical Trials for OSMITROL 20% IN WATER IN PLASTIC CONTAINER

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 20% IN WATER IN PLASTIC CONTAINER clinical trials

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

US Patents and Regulatory Information for OSMITROL 20% 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 20% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-007 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 20% 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/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 20% IN WATER IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OSMITROL 20% in Water in Plastic Containers

Introduction

OSMITROL, a brand name for mannitol, is an obligatory osmotic diuretic widely used in medical settings for various indications, including cerebral edema, oliguria, and the promotion of diuresis. This article delves into the market dynamics and financial trajectory of OSMITROL 20% in water, particularly when packaged in plastic containers.

Clinical Indications and Usage

OSMITROL 20% is indicated for the reduction of intracranial pressure, intracranial edema, and elevated intraocular pressure. It is also used to promote diuresis in intoxications and to manage oliguria in patients with acute kidney injury[1][4].

Market Demand

The demand for OSMITROL is driven by its critical role in managing acute medical conditions. The need for effective diuretics in intensive care units and emergency departments ensures a steady demand for this medication. Additionally, the versatility of mannitol in various medical scenarios contributes to its market stability.

Pricing and Cost Analysis

The cost of OSMITROL 20% intravenous solution varies based on the quantity and pharmacy. For a supply of 12,000 milliliters, the cost is approximately $1,603, with prices ranging depending on the pharmacy and availability[2].

Generic Versions

A generic version of mannitol is available, which can significantly reduce costs. For example, a 6,000 milliliter supply of generic mannitol can cost around $242.66, making it a more affordable option for patients and healthcare providers[2].

Supply Chain and Distribution

OSMITROL is distributed by major pharmaceutical companies, including Baxter Healthcare Corporation. The medication is packaged in VIAFLEX plastic containers, which are fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). These containers are designed to ensure the integrity of the solution and minimize the leaching of chemical components like di-2-ethylhexyl phthalate (DEHP)[1][4].

Financial Trajectory

Revenue Streams

The revenue generated from OSMITROL sales is substantial due to its widespread use in critical care settings. The pricing structure, which varies by concentration and volume, contributes to the overall revenue. For instance, the 20% solution, being one of the most commonly used concentrations, generates significant revenue due to its higher price point compared to lower concentrations[2].

Cost Factors

Several factors influence the financial trajectory of OSMITROL:

  • Production Costs: The cost of manufacturing, including the raw materials and packaging, affects the pricing.
  • Regulatory Compliance: Ensuring compliance with FDA and USP standards incurs additional costs.
  • Distribution and Marketing: Expenses related to distribution, marketing, and patient assistance programs also impact the financials[1][4].

Market Competition

The presence of generic versions of mannitol introduces competition, which can affect the market share and pricing of branded OSMITROL. However, the brand's reputation and the quality assurance provided by Baxter Healthcare Corporation help maintain a significant market presence[2].

Patient Assistance and Discount Programs

To make OSMITROL more accessible, various patient assistance and discount programs are available. For example, the Drugs.com Discount Card can save patients up to 80% on prescription medications, including OSMITROL[2].

Safety and Efficacy Considerations

The safety and efficacy of OSMITROL are critical factors in its market dynamics. The medication is pharmacologically inert and freely filterable at the renal glomerulus, making it effective for its intended uses. However, potential adverse reactions, such as pulmonary congestion and electrolyte imbalances, must be carefully managed[1][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of OSMITROL. Compliance with FDA and USP standards is mandatory, and any changes in regulatory requirements can impact production, distribution, and pricing[1][4].

Future Outlook

The future outlook for OSMITROL 20% in water in plastic containers remains positive due to its essential role in critical care medicine. Advances in packaging technology and ongoing research into new indications could further enhance its market position.

Innovations in Packaging

Innovations in plastic container technology, such as improved barrier properties and reduced leaching of chemical components, can enhance the safety and efficacy of OSMITROL. These advancements may also reduce production costs and improve patient outcomes[3].

Expanding Indications

Research into new clinical indications for mannitol could expand its market potential. For instance, its use in managing other types of edema or in neurosurgical procedures could increase demand and revenue.

Key Takeaways

  • Clinical Indications: OSMITROL 20% is crucial for managing cerebral edema, oliguria, and promoting diuresis.
  • Pricing and Cost: The cost varies by concentration and volume, with generic versions offering more affordable options.
  • Supply Chain: Distributed by major pharmaceutical companies, with packaging in VIAFLEX plastic containers.
  • Financial Trajectory: Influenced by production costs, regulatory compliance, distribution, and market competition.
  • Patient Assistance: Discount programs and patient assistance initiatives make the medication more accessible.
  • Future Outlook: Positive due to its essential role in critical care, with potential for growth through innovations and expanded indications.

FAQs

What are the primary indications for OSMITROL 20%?

OSMITROL 20% is primarily indicated for reducing intracranial pressure, intracranial edema, and elevated intraocular pressure, as well as promoting diuresis in intoxications and managing oliguria.

How much does OSMITROL 20% intravenous solution cost?

The cost of OSMITROL 20% intravenous solution is approximately $1,603 for a supply of 12,000 milliliters, depending on the pharmacy.

Are there generic versions of OSMITROL available?

Yes, generic versions of mannitol are available, which can be significantly more affordable than the branded version.

What are the potential adverse reactions of OSMITROL?

Potential adverse reactions include pulmonary congestion, electrolyte imbalances, hemodilution, and cardiac decompensation, among others.

How is OSMITROL packaged?

OSMITROL is packaged in VIAFLEX plastic containers fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic).

What are the future prospects for OSMITROL in the market?

The future outlook for OSMITROL remains positive due to its critical role in critical care medicine, with potential for growth through innovations in packaging and expanded clinical indications.

Sources

  1. Baxter Corporation. OSMITROL INJECTION - Baxter. [PDF]
  2. Drugs.com. Osmitrol Prices, Coupons, Copay Cards & Patient Assistance.
  3. Google Patents. Controlling the uniformity of PECVD deposition on medical syringes.
  4. FDA. OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov. [PDF]
  5. VWR. Mannitol solution 20% in water, Osmitrol® USP for injection.

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