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Last Updated: December 23, 2024

OSMITROL 10% IN WATER IN PLASTIC CONTAINER Drug Patent Profile


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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. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Drug patent expirations by year for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Recent Clinical Trials for OSMITROL 10% 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 10% IN WATER IN PLASTIC CONTAINER clinical trials

Pharmacology for OSMITROL 10% IN WATER IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased 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 ⤷  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 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/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 10% IN WATER IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

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

Introduction to OSMITROL

OSMITROL, also known as Mannitol Injection USP, is a sterile, nonpyrogenic solution of mannitol, a six-carbon sugar alcohol. It is used as an obligatory osmotic diuretic and is administered intravenously. Mannitol is freely filterable at the renal glomerulus but is only poorly reabsorbed by the renal tubule, making it an effective agent for promoting diuresis and reducing intracranial pressure[2][3].

Market Overview

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

Economic Growth and Healthcare Infrastructure

The market is particularly buoyant in the Asia-Pacific region, including countries like India, China, and Indonesia. These countries are witnessing rapid economic growth, urbanization, and improvements in healthcare infrastructure, leading to increased healthcare spending and access to innovative therapies. The Asian Development Bank forecasts that emerging Asia’s economy will grow by 4.8% in 2023 and 4.9% in 2024, which is expected to boost healthcare investment[4].

Increasing Demand for Mannitol

The demand for mannitol injections is rising due to the increasing incidence of conditions such as brain edema and acute renal failure. In India, for example, the pharmaceutical market is projected to reach USD 120-130 billion by 2030, driven in part by the growing need for treatments like mannitol[4].

Market Size and Forecast

As of 2024, the mannitol injection market was valued at USD 267.1 million. It is projected to grow to USD 367.2 million by 2031, with a Compound Annual Growth Rate (CAGR) of approximately 4.1% during this period. This growth is attributed to the expanding healthcare needs in emerging economies and the increasing prevalence of conditions that require mannitol treatment[4].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is a key driver of the mannitol injection market. Countries in this region are investing heavily in healthcare infrastructure, which is increasing access to advanced medical treatments. The growing middle class in these countries is also contributing to higher healthcare spending, further boosting the demand for mannitol injections[4].

Other Regions

While the Asia-Pacific region is the primary growth driver, other regions such as North America and Europe also contribute to the market. However, the growth in these regions is more stable and less rapid compared to the emerging markets in Asia.

Financial Trajectory

Revenue Growth

The revenue from mannitol injections, including OSMITROL, is expected to increase steadily over the forecast period. The market's CAGR of 4.1% from 2024 to 2031 indicates a consistent and predictable growth trajectory, making it an attractive segment for pharmaceutical companies and investors[4].

Pricing and Cost

The cost of OSMITROL can vary depending on the concentration and volume of the solution. For example, a 10% OSMITROL intravenous solution can cost around $1,288.58 for 12,000 milliliters for cash-paying customers. These prices can fluctuate based on market conditions, competition, and regulatory factors[5].

Competitive Landscape

The mannitol injection market is competitive, with several pharmaceutical companies producing and marketing mannitol solutions. Companies like Baxter International Inc., which manufactures OSMITROL, play a significant role in this market. The competitive landscape is driven by factors such as product quality, pricing, and distribution networks.

Key Challenges and Opportunities

Challenges

  • Regulatory Compliance: Manufacturers must comply with stringent regulatory requirements, including safety tests for the plastic containers used to store the solution[2][3].
  • Side Effects and Risks: Mannitol can cause several side effects, including hyperosmolarity, dehydration, and electrolyte imbalances, which need to be carefully managed by healthcare providers[3].

Opportunities

  • Growing Healthcare Needs: The increasing demand for healthcare services in emerging economies presents a significant opportunity for growth.
  • Innovative Packaging: Improvements in packaging technology, such as the use of specially formulated polyvinyl chloride (PL 146 Plastic) containers, can enhance product safety and shelf life[2][3].

Clinical Pharmacology and Mechanism of Action

Mannitol exerts its osmotic diuretic effect by increasing the osmolarity of the glomerular filtrate, which hinders tubular reabsorption of water and enhances the excretion of sodium and chloride. This mechanism is crucial for reducing intracranial pressure, intracranial edema, and intraocular pressure[3].

Conclusion

The market for OSMITROL 10% in water in plastic containers is poised for steady growth, driven by increasing healthcare needs in emerging economies and the rising incidence of conditions that require mannitol treatment. The financial trajectory of this market indicates a predictable and consistent growth rate, making it an attractive segment for pharmaceutical companies and investors.

Key Takeaways

  • The mannitol injection market is valued at USD 267.1 million in 2024 and is projected to reach USD 367.2 million by 2031.
  • The Asia-Pacific region is a key driver of market growth due to economic expansion and improvements in healthcare infrastructure.
  • OSMITROL is used as an obligatory osmotic diuretic and is effective in reducing intracranial pressure and treating conditions like brain edema.
  • The market faces challenges such as regulatory compliance and potential side effects but offers opportunities for growth through innovative packaging and increasing healthcare needs.

FAQs

Q: What is OSMITROL used for? A: OSMITROL is used as an obligatory osmotic diuretic to promote diuresis, reduce intracranial pressure, and treat conditions such as brain edema and acute renal failure[2][3].

Q: What are the potential side effects of OSMITROL? A: Potential side effects include hyperosmolarity, dehydration, hemoconcentration, and electrolyte imbalances such as hypernatremia and hyponatremia[3].

Q: How is OSMITROL administered? A: OSMITROL is administered intravenously in a sterile, nonpyrogenic solution[2][3].

Q: What is the projected growth rate of the mannitol injection market? A: The mannitol injection market is projected to grow at a CAGR of approximately 4.1% from 2024 to 2031[4].

Q: Which regions are driving the growth of the mannitol injection market? A: The Asia-Pacific region, particularly countries like India, China, and Indonesia, is driving the growth of the mannitol injection market due to economic growth and improvements in healthcare infrastructure[4].

Sources

  1. Baxter: Prescribing Information Osmitrol Injection 10% - Baxter.
  2. FDA: OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov.
  3. FDA: OSMITROL Injection (Mannitol Injection, USP) - accessdata.fda.gov.
  4. Verified Market Research: In-Depth Industry Outlook: Mannitol Injection Market Size & Forecast.
  5. Drugs.com: Osmitrol Prices, Coupons, Copay Cards & Patient Assistance.

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