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Last Updated: December 22, 2024

MILRINONE LACTATE IN DEXTROSE 5% Drug Patent Profile


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Which patents cover Milrinone Lactate In Dextrose 5%, and when can generic versions of Milrinone Lactate In Dextrose 5% launch?

Milrinone Lactate In Dextrose 5% is a drug marketed by Eugia Pharma, Woodward, B Braun, Baxter Hlthcare, Gland Pharma Ltd, Hikma, Hospira, and West-ward Pharms Int. and is included in nine NDAs.

The generic ingredient in MILRINONE LACTATE IN DEXTROSE 5% 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 Dextrose 5%

A generic version of MILRINONE LACTATE IN DEXTROSE 5% was approved as milrinone lactate by FRESENIUS KABI USA on May 28th, 2002.

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Summary for MILRINONE LACTATE IN DEXTROSE 5%
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Recent Clinical Trials for MILRINONE LACTATE IN DEXTROSE 5%

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

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Pharmacology for MILRINONE LACTATE IN DEXTROSE 5%

US Patents and Regulatory Information for MILRINONE LACTATE IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eugia Pharma MILRINONE LACTATE IN DEXTROSE 5% milrinone lactate INJECTABLE;INJECTION 209666-001 Sep 3, 2020 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 075834-002 May 28, 2002 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 076414-001 Aug 18, 2004 DISCN 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 DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Milrinone Lactate in 5% Dextrose Injection

Introduction

Milrinone lactate in 5% dextrose injection is a critical medication used in the treatment of acute decompensated heart failure. It belongs to a class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Overview

The market for milrinone lactate is driven by the increasing prevalence of heart failure, particularly acute decompensated heart failure. Heart failure is a significant health concern globally, with millions of people affected each year. The demand for effective treatments, such as milrinone lactate, is consequently high[2][4].

Competitive Landscape

The competitive landscape for milrinone lactate involves several pharmaceutical companies, including Pfizer, Hikma Pharmaceuticals, and others. These companies offer milrinone lactate in various formulations, including ready-to-use intravenous solutions and premixed bags. The competition is based on factors such as product quality, pricing, and distribution networks[3][5].

Product Formulations and Availability

Milrinone lactate is available in several formulations, including:

  • Ready-to-use intravenous piggybacks at concentrations of 200 mcg/mL.
  • Premixed bags in 100 mL and 200 mL volumes of 5% dextrose injection, each containing 200 mcg/mL of milrinone lactate.
  • Concentrated solutions in 10-mL and 20-mL vials at a concentration of 1 mg/mL[2][3][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of milrinone lactate. The drug is approved for the short-term intravenous treatment of patients with acute decompensated heart failure. Regulatory bodies such as the FDA closely monitor the manufacturing, distribution, and use of this medication to ensure safety and efficacy[2][4].

Pharmacokinetics and Clinical Use

Understanding the pharmacokinetics of milrinone lactate is essential for its clinical use. The drug has a volume of distribution of about 0.38-0.45 liters/kg, a mean terminal elimination half-life of 2.3-2.4 hours, and a clearance of 0.13-0.14 liters/kg/hr. It is approximately 70% bound to human plasma protein. These parameters guide the dosing and administration of the drug, which typically involves a loading dose followed by a continuous infusion[2][4].

Pricing and Reimbursement

The pricing of milrinone lactate can vary based on the formulation, concentration, and geographical location. In the United States, for example, the premixed bags are priced based on their volume and concentration. Reimbursement policies also play a significant role, with many health insurance plans covering the cost of this medication due to its critical nature in treating acute heart failure[5].

Financial Performance

The financial performance of milrinone lactate is influenced by several factors, including sales volume, pricing, and market competition. Given its essential role in treating heart failure, the drug generates significant revenue for pharmaceutical companies. Here are some key financial indicators:

  • Sales Volume: The sales volume of milrinone lactate has been steady due to the consistent demand for heart failure treatments.
  • Revenue Growth: The revenue from milrinone lactate has seen a steady growth trajectory, driven by the increasing prevalence of heart failure and the drug's efficacy.
  • Market Share: Pharmaceutical companies that manufacture milrinone lactate compete for market share, with leading companies like Pfizer and Hikma holding significant portions of the market[3][5].

Future Outlook

The future outlook for milrinone lactate in 5% dextrose injection is positive, driven by several factors:

  • Increasing Prevalence of Heart Failure: The global incidence of heart failure is expected to rise, increasing the demand for effective treatments.
  • Advancements in Formulations: Continuous improvements in formulations and delivery systems can enhance patient compliance and treatment outcomes.
  • Regulatory Support: Ongoing regulatory support and approval for new indications can further expand the market for milrinone lactate[2][4].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

  • Challenges: Competition from other heart failure treatments, regulatory hurdles, and pricing pressures can impact the market.
  • Opportunities: Expanding into new markets, developing new formulations, and enhancing distribution networks can provide growth opportunities[3][5].

Key Takeaways

  • Market Demand: The market for milrinone lactate is driven by the increasing prevalence of heart failure.
  • Competitive Landscape: Multiple pharmaceutical companies compete in the market, offering various formulations.
  • Regulatory Environment: Regulatory approvals and monitoring are crucial for the drug's market presence.
  • Financial Performance: The drug generates significant revenue due to its critical role in treating heart failure.
  • Future Outlook: The market is expected to grow due to increasing demand and advancements in formulations.

FAQs

  1. What is milrinone lactate used for?

    • Milrinone lactate is used for the short-term intravenous treatment of patients with acute decompensated heart failure[2][4].
  2. How is milrinone lactate administered?

    • It is administered with a loading dose followed by a continuous infusion. The loading dose is typically 50 mcg/kg administered slowly over 10 minutes[2][4].
  3. What are the common formulations of milrinone lactate?

    • It is available in ready-to-use intravenous solutions and premixed bags in 100 mL and 200 mL volumes of 5% dextrose injection[2][3][5].
  4. What are the pharmacokinetic parameters of milrinone lactate?

    • It has a volume of distribution of about 0.38-0.45 liters/kg, a mean terminal elimination half-life of 2.3-2.4 hours, and a clearance of 0.13-0.14 liters/kg/hr[2][4].
  5. Is milrinone lactate covered by health insurance?

    • Yes, many health insurance plans cover the cost of milrinone lactate due to its critical nature in treating acute heart failure[5].

Cited Sources

  1. Stability of Milrinone Lactate in 5% Dextrose Injection and 0.9% Sodium Chloride Injection - PubMed.
  2. Milrinone Lactate in 5% Dextrose Injection Rx only - DailyMed.
  3. Milrinone Lactate in 5% Dextrose Injection - Pfizer.
  4. Milrinone Lactate Injection, Solution - DailyMed.
  5. Milrinone Lactate in 5% Dextrose Injection Premixed Bag - Eugia US.

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