You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

OSMITROL 5% IN WATER IN PLASTIC CONTAINER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Osmitrol 5% In Water In Plastic Container, and when can generic versions of Osmitrol 5% In Water In Plastic Container launch?

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

The generic ingredient in OSMITROL 5% 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.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
  • What are the global sales for OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for OSMITROL 5% IN WATER IN PLASTIC CONTAINER?
Summary for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Drug patent expirations by year for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Recent Clinical Trials for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

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

SponsorPhase
CPR Pharma Services Pty Ltd, AustraliaPhase 1
Celtaxsys, Inc.Phase 1
Clinical Network ServicesPhase 1

See all OSMITROL 5% IN WATER IN PLASTIC CONTAINER clinical trials

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

US Patents and Regulatory Information for OSMITROL 5% 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 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 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 5% IN WATER IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OSMITROL (Mannitol Injection)

Market Overview

The mannitol injection market, which includes products like OSMITROL, is experiencing significant growth driven by several key factors.

Demographic Drivers

The aging population, particularly in North America, is a major driver for the mannitol injection market. As the elderly population grows, so does the incidence of age-related conditions such as Alzheimer’s dementia and chronic renal disease, which often require mannitol injections to manage intracranial pressure and fluid balance. By 2060, the number of Americans aged 65 and older is expected to nearly double from 52 million in 2018 to 95 million[1].

Healthcare Spending in Asia-Pacific

The Asia-Pacific region is witnessing rapid expansion in healthcare spending, which is another significant driver for the mannitol injection market. Countries like India, China, and Indonesia are experiencing economic growth, urbanization, and improvements in healthcare infrastructure, leading to increased demand for innovative therapies. For instance, India’s healthcare industry is projected to grow to USD 372 billion by 2022, and the pharmaceutical market in India is estimated to reach USD 120-130 billion by 2030[1].

Economic Growth and Urbanization

The economic growth in emerging Asia, expected to be around 4.8% in 2023 and 4.9% in 2024, is boosting healthcare investment in the region. This economic surge, coupled with urbanization and improvements in healthcare infrastructure, is driving up healthcare spending and access to specialized treatments like mannitol injections[1].

Market Size and Forecast

  • The mannitol injection market was valued at USD 267.1 million in 2024 and is projected to reach USD 367.2 million by 2031, growing at a CAGR of 4.1% from 2024 to 2031[1].

Regional Market Dynamics

North America

  • The large and growing aging population in North America is a key driver for the market. The increased prevalence of age-related conditions will continue to drive demand for mannitol injections[1].

Asia-Pacific

  • This region is expected to experience the most rapid expansion in the mannitol injection market due to increased healthcare spending and economic growth. Countries like India, China, and Indonesia are at the forefront of this growth[1].

Product Indications and Usage

Therapeutic Uses

  • OSMITROL (mannitol injection) is indicated for several therapeutic uses, including the promotion of diuresis, prevention and treatment of the oliguric phase of acute renal failure, reduction of intracranial pressure, and treatment of cerebral edema. It is also used to reduce intraocular pressure and to promote the excretion of toxic substances through forced diuresis[2][4].

Mechanism of Action

  • Mannitol exerts its osmotic diuretic effect by hindering tubular reabsorption of water and enhancing the excretion of sodium and chloride. This increases extracellular osmolarity, which helps in reducing intracranial pressure, intracranial edema, and intraocular pressure[3].

Product Composition and Packaging

Composition

  • OSMITROL is available in various concentrations, including 5%, 10%, 15%, and 20% mannitol solutions. The pH is adjusted with sodium hydroxide or hydrochloric acid, and the solutions are sterile and nonpyrogenic[3][5].

Packaging

  • The product is supplied in single-dose, flexible VIAFLEX plastic containers. These containers are fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic) and are designed to minimize the leaching of chemical components[3][5].

Clinical Pharmacology

Distribution and Elimination

  • Mannitol distributes largely in the extracellular space within 20 to 40 minutes after intravenous administration. The volume of distribution is approximately 17 liters in adults. In subjects with normal renal function, the total clearance is 87 to 109 mL/min[3].

Market Trends and Growth Factors

Increasing Healthcare Spending

  • The increase in healthcare spending globally, particularly in the Asia-Pacific region, is a significant trend driving the market. As countries invest more in healthcare infrastructure and services, the demand for specialized treatments like mannitol injections is expected to rise[1].

Technological Advancements

  • Improvements in medical technology and the development of more efficient delivery systems for mannitol injections are also contributing to market growth.

Regulatory Environment

  • The regulatory environment plays a crucial role in the market dynamics. Ensuring compliance with FDA regulations and other international standards is essential for the continued growth of the mannitol injection market.

Competitive Landscape

The mannitol injection market is competitive, with several key players operating globally. Companies like Baxter Healthcare Corporation are prominent in this market, providing a range of mannitol injection products in different concentrations and packaging options[3].

Financial Trajectory

Revenue Forecast

  • The market is expected to grow from USD 267.1 million in 2024 to USD 367.2 million by 2031, with a CAGR of 4.1% during the forecast period[1].

Key Revenue Streams

  • The primary revenue streams for the mannitol injection market come from hospital and clinical settings where these injections are used to treat various medical conditions.

Challenges and Opportunities

Challenges

  • One of the challenges facing the market is the potential for vein damage associated with the administration of substantially hypertonic solutions (> 600 mOsmol/L)[5].

Opportunities

  • The growing demand for mannitol injections in emerging markets, particularly in the Asia-Pacific region, presents significant opportunities for market expansion.

Key Takeaways

  • The mannitol injection market is driven by demographic changes, increased healthcare spending, and economic growth.
  • The Asia-Pacific region is expected to be a major growth driver due to its rapid economic expansion and improvements in healthcare infrastructure.
  • OSMITROL (mannitol injection) is used for various therapeutic indications and is available in different concentrations.
  • The market is expected to grow at a CAGR of 4.1% from 2024 to 2031.

FAQs

Q: What are the primary therapeutic uses of OSMITROL (mannitol injection)?

  • OSMITROL is used for the promotion of diuresis, prevention and treatment of the oliguric phase of acute renal failure, reduction of intracranial pressure, treatment of cerebral edema, reduction of intraocular pressure, and to promote the excretion of toxic substances through forced diuresis[2][4].

Q: How does mannitol exert its osmotic diuretic effect?

  • Mannitol hinders tubular reabsorption of water and enhances the excretion of sodium and chloride by elevating the osmolarity of the glomerular filtrate, which increases extracellular osmolarity and induces the movement of intracellular water to the extracellular and vascular spaces[3].

Q: What are the different concentrations of OSMITROL available?

  • OSMITROL is available in 5%, 10%, 15%, and 20% mannitol solutions[3][5].

Q: What is the expected growth rate of the mannitol injection market from 2024 to 2031?

  • The mannitol injection market is expected to grow at a CAGR of 4.1% from 2024 to 2031[1].

Q: Which region is expected to drive the most rapid expansion in the mannitol injection market?

  • The Asia-Pacific region is expected to experience the most rapid expansion due to increased healthcare spending and economic growth[1].

Sources

  1. Verified Market Research, "In-Depth Industry Outlook: Mannitol Injection Market Size & Forecast"
  2. Baxter, "OSMITROL INJECTION - Baxter"
  3. FDA, "OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov"
  4. RxList, "Osmitrol in Viaflex - RxList"
  5. FDA, "OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov"

More… ↓

⤷  Subscribe

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. 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.