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Last Updated: December 22, 2024

MILRINONE LACTATE IN PLASTIC CONTAINER Drug Patent Profile


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When do Milrinone Lactate In Plastic Container patents expire, and what generic alternatives are available?

Milrinone Lactate In Plastic Container is a drug marketed by Hikma Farmaceutica and is included in one NDA.

The generic ingredient in MILRINONE LACTATE IN PLASTIC CONTAINER is milrinone lactate. There are nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the milrinone lactate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Milrinone Lactate In Plastic Container

A generic version of MILRINONE LACTATE IN PLASTIC CONTAINER was approved as milrinone lactate by FRESENIUS KABI USA on May 28th, 2002.

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Summary for MILRINONE LACTATE IN PLASTIC CONTAINER
Drug patent expirations by year for MILRINONE LACTATE IN PLASTIC CONTAINER
Recent Clinical Trials for MILRINONE LACTATE IN PLASTIC CONTAINER

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SponsorPhase
Shanghai Children's Medical CenterPhase 3
Ottawa Heart Institute Research CorporationPhase 4
University of PennsylvaniaN/A

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Pharmacology for MILRINONE LACTATE IN PLASTIC CONTAINER

US Patents and Regulatory Information for MILRINONE LACTATE 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
Hikma Farmaceutica MILRINONE LACTATE IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 090038-001 Jan 21, 2010 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma Farmaceutica MILRINONE LACTATE IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 090038-002 Jan 21, 2010 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

MILRINONE LACTATE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Milrinone Lactate

Introduction to Milrinone Lactate

Milrinone Lactate is a small molecule drug developed by Sanofi, primarily used for the treatment of heart failure. It belongs to the class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, targeting the enzyme cGMP-PDE to increase cyclic guanosine monophosphate (cGMP) levels, leading to vasodilation and improved cardiac contractility[4][5].

Market Overview

Historical Market Performance

The Milrinone Lactate market has shown significant growth over the years. From 2013 to 2017, the market revenue increased substantially, and it is projected to continue growing until 2023 with a notable Compound Annual Growth Rate (CAGR)[1].

Market Segmentation

The market can be segmented based on product types, major applications, and important regions. Key regions include North America, Europe, China, Japan, Middle East & Africa, and India, each with its own production value and growth rate[1].

Key Players and Competitive Landscape

The Milrinone Lactate market is dominated by several major players, including Sanofi, the originator of the drug. Other companies also play significant roles in the production and distribution of Milrinone Lactate. The competitive landscape is characterized by intense competition, with multiple companies focusing on small molecule drugs targeting cardiovascular diseases[1][4].

Regulatory Status and Approval

Milrinone Lactate was first approved in December 1987 in the United States and has since received priority review and orphan drug designation due to its high potential in treating heart failure. This regulatory status highlights its importance in addressing a critical medical need[4].

Pharmacokinetics and Clinical Use

The pharmacokinetics of Milrinone Lactate have been extensively studied, particularly in pediatric patients with septic shock and in adults with heart failure. The drug is administered intravenously, with loading doses and maintenance infusions tailored to achieve optimal hemodynamic effects. The median half-life of Milrinone Lactate is approximately 1.47 hours, and it is significantly bound to human plasma protein[2][5].

Market Value and Forecast

Global Market Value

The global Milrinone Lactate market value has been increasing steadily. From 2013 to 2017, the market saw significant growth, and it is expected to reach a substantial value by 2023. The CAGR during the forecast period indicates a robust market trajectory[1].

Regional Market Forecast

Regional markets such as North America, Europe, and Asia-Pacific are expected to contribute significantly to the overall market growth. The forecast includes detailed projections for each region, highlighting production values, consumption, and export-import dynamics[1].

SWOT Analysis by Regions

Each region has its own strengths, weaknesses, opportunities, and threats. For instance:

  • North America: Strong healthcare infrastructure and high demand for cardiovascular treatments.
  • Europe: Regulatory support and a large patient base.
  • China: Rapidly growing pharmaceutical market and increasing focus on cardiovascular diseases.
  • Japan: Advanced healthcare system and aging population driving demand.
  • Middle East & Africa: Growing healthcare needs and increasing investment in pharmaceuticals[1].

Financial Trajectory

Revenue Growth

The revenue of the Milrinone Lactate market has been increasing steadily. The market revenue grew from a significant figure in 2013 to a higher figure in 2017 and is projected to reach an even higher figure by 2023. This growth is driven by increasing demand for effective heart failure treatments and the drug's proven efficacy[1].

Gross Margin and Pricing

The gross margin and pricing of Milrinone Lactate vary by region and are influenced by production costs, market competition, and regulatory factors. The drug's pricing strategy is crucial for maintaining profitability while ensuring accessibility to patients[1].

Future Outlook

R&D Progress

The ongoing research and development in the cGMP-PDE target area indicate a promising future for Milrinone Lactate and similar drugs. With multiple clinical trials and new drug developments, the competitive landscape is expected to evolve, potentially introducing new competitors and innovations[4].

Market Opportunities

The growing prevalence of heart failure and the need for effective treatments present significant market opportunities. Emerging markets, particularly in Asia-Pacific, offer substantial growth potential due to increasing healthcare spending and a rising patient population[1][4].

Challenges and Limitations

Patient Compliance

One of the significant challenges in the pharmaceutical industry, including for Milrinone Lactate, is patient compliance. Studies have shown that about 50% of patients do not comply with prescribed medication regimens, which can lead to reduced efficacy and increased healthcare costs[3].

Competition from Biosimilars

The future development of the cGMP-PDE target area may include competition from biosimilars, which could impact the market share of Milrinone Lactate. However, the drug's established position and regulatory approvals provide a strong foundation for its continued market presence[4].

Key Takeaways

  • Market Growth: The Milrinone Lactate market is expected to grow significantly, driven by increasing demand for heart failure treatments.
  • Regulatory Status: The drug has received priority review and orphan drug designation, highlighting its importance in treating heart failure.
  • Pharmacokinetics: The drug's pharmacokinetics support its efficacy in improving hemodynamic parameters in patients with heart failure.
  • Competitive Landscape: The market is competitive, with multiple players focusing on small molecule drugs targeting cardiovascular diseases.
  • Future Outlook: Emerging markets and ongoing R&D in the cGMP-PDE target area present opportunities for growth and innovation.

FAQs

  1. What is Milrinone Lactate used for? Milrinone Lactate is primarily used for the treatment of heart failure, targeting the enzyme cGMP-PDE to increase cyclic guanosine monophosphate (cGMP) levels, leading to vasodilation and improved cardiac contractility[4][5].

  2. Who is the originator of Milrinone Lactate? The originator of Milrinone Lactate is Sanofi, a well-known pharmaceutical company[4].

  3. What is the regulatory status of Milrinone Lactate? Milrinone Lactate has received priority review and orphan drug designation due to its high potential in treating heart failure[4].

  4. How is Milrinone Lactate administered? Milrinone Lactate is administered intravenously, typically with a loading dose followed by a maintenance infusion[2][5].

  5. What are the potential challenges for Milrinone Lactate in the future? Potential challenges include competition from biosimilars and the need to address patient compliance issues to ensure the drug's efficacy and market sustainability[3][4].

Sources

  1. Global Milrinone Lactate Industry Market Research Report - Maiaresearch[1]
  2. Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - PubMed[2]
  3. Pharma-informatics system - Google Patents[3]
  4. An In-depth Analysis of Milrinone Lactate's R&D Progress and Market Dynamics - Synapse Patsnap[4]
  5. Milrinone Lactate in 5% Dextrose Injection Rx only - DailyMed[5]

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