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Last Updated: December 12, 2025

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 Caplin, Eugia Pharma, Woodward, B Braun, Baxter Hlthcare, Gland, Hikma, and Hospira. and is included in ten 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%
Drug patent expirations by year for MILRINONE LACTATE IN DEXTROSE 5%
Recent Clinical Trials for MILRINONE LACTATE IN DEXTROSE 5%

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

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

See all MILRINONE LACTATE IN DEXTROSE 5% clinical trials

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
Caplin MILRINONE LACTATE IN DEXTROSE 5% milrinone lactate INJECTABLE;INJECTION 219170-001 Sep 2, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 075834-001 May 28, 2002 AP RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Eugia Pharma MILRINONE LACTATE IN DEXTROSE 5% milrinone lactate INJECTABLE;INJECTION 209666-002 Sep 3, 2020 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hikma MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 075510-001 May 28, 2002 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Last updated: July 31, 2025

Introduction
Milrinone lactate in dextrose 5% is a peripheral parenteral inotropic agent primarily used to manage acute heart failure and cardiogenic shock. Its unique pharmacological profile as a phosphodiesterase III inhibitor offers immediate hemodynamic improvements, making it critical in intensive care settings. As the global cardiovascular disease burden escalates, understanding the market dynamics and projecting financial trajectories for milrinone lactate in dextrose 5% become essential for stakeholders, including pharmaceutical companies, healthcare providers, and investors.


Market Overview and Segmentation
The market for inotropic agents like milrinone lactate in dextrose 5% is characterized by its niche within acute cardiovascular care, particularly in hospital settings such as intensive care units (ICUs) and cardiac surgery units. The primary customers include hospitals, clinics, and emergency care facilities.

Segmentation insights include:

  • Application-wise: Acute decompensated heart failure, cardiogenic shock, and perioperative management.
  • End-user-wise: Large hospitals with specialized cardiac units constitute the main revenue drivers, with a growing interest from outpatient and home care segments in certain markets.

Market Drivers

  1. Rising Incidence of Heart Failure
    The WHO estimates over 23 million individuals globally suffer from heart failure, with numbers expected to rise owing to aging populations and lifestyle factors [1]. Milrinone’s role as a quick-acting inotropic agent makes it pivotal in managing acute episodes.

  2. Increasing Use of Critical Care Therapeutics
    Advancements in ICU capabilities and an emphasis on rapid stabilization of cardiac function drive demand for potent inotropic agents. Milrinone’s rapid onset and short duration allow tailored management in acute settings.

  3. Growing Adoption of Evidence-Based Practice
    Clinical guidelines increasingly recognize the role of milrinone for select patient populations, bolstered by research demonstrating its efficacy in improving cardiac output with minimal arrhythmogenic potential.

  4. Technological and Manufacturing Advances
    Enhanced formulation stability, scalable manufacturing, and the ability to produce milrinone in ready-to-use solutions like dextrose 5% simplifies hospital supply chains, fostering wider adoption.


Market Challenges

  1. Availability of Alternatives
    Agents such as dobutamine, levosimendan, and epinephrine serve as substitutes, often influencing treatment choices based on patient-specific factors and clinician preferences.

  2. Regulatory and Reimbursement Barriers
    Stringent approval processes and variable reimbursement policies across regions impact market penetration, particularly in emerging economies.

  3. Safety Concerns and Side Effects
    Potential side effects, including arrhythmias and hypotension, necessitate careful patient monitoring, which may limit widespread use in less-equipped facilities.

  4. Pricing and Economic Constraints
    High drug costs and budget constraints in healthcare systems restrict utilization, especially in low- to middle-income regions.


Regional Market Analysis

  • North America: The largest market driven by high cardiovascular disease prevalence, advanced healthcare infrastructure, and favorable reimbursement landscapes. US hospitals utilize milrinone extensively, with market growth poised to continue.

  • Europe: Similar to North America, but constrained by regulatory formalities and economic factors influencing procurement.

  • Asia-Pacific: Rapidly expanding healthcare infrastructure, rising cardiovascular disease rates, and increasing healthcare expenditure underpin growth opportunities. However, regulatory hurdles and pricing sensitivities remain.

  • Latin America and Middle East & Africa: Emerging markets show growth potential, yet market penetration hampers due to affordability, regulatory delays, and limited clinical awareness.


Financial Trajectory Analysis

Historical Revenue Trends
The global market for inotropic agents, including milrinone lactate in dextrose 5%, was valued at approximately USD 350 million in 2020 and is projected to reach USD 520 million by 2027, with a CAGR of around 6.5% [2].

Factors Influencing Future Growth

  • Product Lifecycle and Patent Status: As generic formulations proliferate, price competition is expected to intensify, potentially limiting margins but expanding access.

  • Innovation and New Formulations: Development of sustained-release or combination formulations could enhance market appeal.

  • Regulatory Approvals: Expansion into new indications or breakthrough designations may accelerate market growth and revenue streams.

  • Strategic Partnerships and Market Expansion: Collaborations with regional healthcare distributors and localized manufacturing can reduce costs and accelerate adoption.

Profitability Outlook
Manufacturers maintaining cost-efficient production and navigating regulatory pathways effectively could see sustained profitability. Conversely, price pressures from generics and competitive substitutes might compress margins, emphasizing the need for strategic differentiation.


Regulatory and Reimbursement Landscape

  • In developed markets, reimbursement policies favor critical care medications with established efficacy. Potential inclusion in hospital formularies sustains demand.

  • Emerging markets often face reimbursement uncertainties, demanding strategic pricing and engagement with healthcare policymakers to stimulate growth.


SWOT Analysis of Milrinone Lactate in Dextrose 5%

Strengths Weaknesses
Proven efficacy in acute scenarios Competition from alternatives
Favorable pharmacokinetics Cost sensitivity
Established manufacturing pathways Limited outpatient application
Opportunities Threats
Rising cardiovascular disease burden Regulatory barriers
Expanding critical care infrastructure Price erosion due to generics
Innovation in drug formulations Substitution by new inotropes

Key Market Players and Strategic Moves

Major companies such as Pfizer, Novartis, and Teva manufacture or distribute milrinone formulations. Strategies include expanding manufacturing capacity, pursuing new regulatory approvals, and forming regional partnerships. For example, Pfizer’s global reach and regulatory experience position it favorably in both developed and emerging markets.


Future Outlook and Investment Opportunities

The demand for milrinone lactate in dextrose 5% will likely grow steadily, driven by the aging global population and the increasing prevalence of cardiovascular complications requiring critically timed hemodynamic support. Companies that innovate with formulations, reduce manufacturing costs, and navigate regulatory pathways appropriately will capitalize on these trends. Conversely, the market may face pricing pressures as patents expire, necessitating strategic planning to sustain profitability.


Key Takeaways

  • Rising cardiovascular disease globally sustains demand for inotropic agents like milrinone lactate in dextrose 5%.
  • Market growth will be driven by hospital-centric applications, especially in ICU and perioperative care, with regional disparities influencing expansion.
  • Competition from alternative inotropes and generics warrants innovation and strategic positioning for sustained profitability.
  • Regulatory complexities and reimbursement frameworks significantly influence market access and revenue trajectories.
  • Stakeholders should focus on regional expansion, formulation innovation, and cost management to maximize returns amid evolving healthcare landscapes.

FAQs

1. What are the main clinical indications for milrinone lactate in dextrose 5%?
Primarily used for acute management of heart failure and cardiogenic shock in hospital settings, especially in ICU and cardiac surgery units.

2. How does milrinone compare to other inotropes like dobutamine?
Milrinone offers longer-lasting hemodynamic effects, lower arrhythmogenic potential, and can be used in patients unresponsive to other agents. However, choice depends on patient profile and institutional protocols.

3. What factors could impact the future growth of milrinone lactate markets?
Regulatory barriers, emergence of new therapies, pricing pressures, and the availability of effective substitutes influence growth trajectories.

4. Are there upcoming innovations in milrinone formulations?
Potential developments include sustained-release formulations, combination therapies, and alternative delivery methods to enhance efficacy and ease of use.

5. How do regional regulations affect market entry?
Differences in approval processes, pricing policies, and reimbursement schemes require tailored strategies for each geographical market, influencing timelines and profitability.


Sources
[1] World Health Organization. "Cardiovascular diseases (CVDs)." 2021.
[2] Market Research Future. "Inotropic Agents Market Analysis." 2022.

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