MILRINONE LACTATE - Generic Drug Details

What are the generic sources for milrinone lactate and what is the scope of freedom to operate?

Milrinone lactate is the generic ingredient in six branded drugs marketed by Baxter Hlthcare Corp, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Intl Medicated, Meitheal, Mylan Institutional, Shandong, Eugia Pharma, Woodward, B Braun, Baxter Hlthcare, Gland, and Sanofi Aventis Us, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for MILRINONE LACTATE

US Patents:	0
Tradenames:	6
Applicants:	17
NDAs:	28
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	5
Drug Prices:	Drug price trends for MILRINONE LACTATE
What excipients (inactive ingredients) are in MILRINONE LACTATE?	MILRINONE LACTATE excipients list
DailyMed Link:	MILRINONE LACTATE at DailyMed

See drug prices for MILRINONE LACTATE

Recent Clinical Trials for MILRINONE LACTATE

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

Sponsor	Phase
Shanghai Children's Medical Center	Phase 3
Ottawa Heart Institute Research Corporation	Phase 4
Bedford Pharmaceuticals	N/A

See all MILRINONE LACTATE clinical trials

Pharmacology for MILRINONE LACTATE

Drug Class	Phosphodiesterase 3 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors

Medical Subject Heading (MeSH) Categories for MILRINONE LACTATE

Cardiotonic Agents

Phosphodiesterase 3 Inhibitors

Platelet Aggregation Inhibitors

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for MILRINONE LACTATE

C01CE	Phosphodiesterase inhibitors
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for MILRINONE LACTATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	211671-001	Mar 24, 2020	AP	RX	No	No
Shandong	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	216373-001	Jan 23, 2023	AP	RX	No	No
Baxter Hlthcare	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	075834-002	May 28, 2002	AP	RX	No	Yes

Expired US Patents for MILRINONE LACTATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PRIMACOR	milrinone lactate	INJECTABLE;INJECTION	019436-001	Dec 31, 1987	4,313,951*PED
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994	4,313,951*PED
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994	4,313,951*PED

Market Dynamics and Financial Trajectory for Milrinone Lactate

Last updated: July 27, 2025

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Introduction

Milrinone lactate, a phosphodiesterase III inhibitor, plays a pivotal role in managing acute decompensated heart failure and cardiogenic shock. Its rapid onset of action and potent inotropic and vasodilatory effects position it as a critical therapeutic agent within intensive care and cardiology settings. As the global cardiovascular disease burden escalates, understanding the market dynamics and financial trajectory of milrinone lactate warrants strategic insights for pharmaceutical stakeholders, healthcare providers, and investors.

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Pharmacological Profile and Clinical Applications

Milrinone acts by inhibiting phosphodiesterase III, leading to increased cyclic AMP levels within myocardial and vascular smooth muscle, thereby enhancing cardiac contractility and reducing systemic vascular resistance. It is primarily administered intravenously for acute cases, especially during cardiac surgeries, exacerbations of heart failure, or cardiogenic shock scenarios.

The drug’s clinical utility spans several European, North American, and APAC markets, fostered by guidelines emphasizing its use in managing perioperative heart failure and refractory systemic hypotension. However, safety concerns, notably arrhythmogenic potential and hypotension, influence prescribing patterns.

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Market Dynamics

1. Growth Drivers

• Rising Cardiovascular Disease Incidence: According to the World Health Organization (WHO), cardiovascular diseases (CVD) account for approximately 17.9 million deaths annually, with heart failure incidences increasing due to aging populations and lifestyle shifts. This directly correlates with heightened demand for inotropic agents like milrinone.

• Advancements in Critical Care: Innovations in intensive care units (ICUs) and expanding access to advanced cardiac life support systems facilitate greater utilization of milrinone during surgical interventions and acute episodes.

• Emerging Market Penetration: Increasing healthcare infrastructure investment in emerging economies (particularly China and India) expands the reach of advanced inotropic therapies, thereby opening new sales avenues.

• Strategic Partnerships & Approvals: Certain generics and biosimilars have gained approvals across various jurisdictions, fostering competitive pricing and wider accessibility.

2. Market Restraints

• Safety and Alternative Therapies: Concerns over proarrhythmic effects and hypotension restrict use in certain patient populations. The advent of alternative agents such as levosimendan and other inotropes (e.g., dobutamine) limits exclusive reliance on milrinone.

• Regulatory and Reimbursement Challenges: Stringent regulatory oversight in developed markets and variable reimbursement policies influence market penetration and profitability.

• Generic Competition and Pricing Pressures: Patent expirations and genericization induce price erosions, impacting profit margins.

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Competitive Landscape

Global sales are primarily driven by a mix of branded formulations (e.g., Primacor in the US) and generics, with key players including Fresenius Kabi, Hospira, Dr. Reddy’s Laboratories, and local pharmaceutical companies in emerging markets. The competitive dynamics are shaped by price strategies, regulatory approvals, and supply chain robustness.

Emerging biosimilar and generic entrants are intensifying competition, compelling incumbent manufacturers to innovate and optimize cost structures. Additionally, the limited pipeline of novel milrinone formulations restricts long-term differentiation strategies.

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Regulatory and Patent Environment

Milrinone's patent protection, primarily expired in multiple markets, has facilitated the proliferation of generic versions, compressing profit margins. Regulatory bodies like the FDA and EMA maintain rigorous standards for injectable pharmaceuticals, affecting time-to-market and compliance costs. Emerging markets often display regulatory variations, further influencing global supply chains.

Recent regulatory challenges focus on ensuring manufacturing safety and addressing concerns about adverse effects, which could shape the drug’s market viability.

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Financial Trajectory and Forecasts

Historical Financial Performance

The global milrinone market size was valued at approximately USD 200-300 million in recent years, with growth rates around 3-5% annually. North America remains the dominant segment, owing to advanced healthcare infrastructure and clinical practice guidelines supporting its use. European markets follow, while Asia’s share is rising rapidly due to increasing cardiovascular disease burden and infrastructural expansion.

Projected Market Trends (2023-2030)

• Compound Annual Growth Rate (CAGR): Expected to stabilize around 4-5%, driven by aging populations and improved critical care access.

• Market Expansion Factors:

  • Increased adoption in emerging markets.
  • Integration into cardiac surgical protocols.
  • Growing research into safer formulations.

• Revenue Outlook:

  • In complex scenarios, revenues could escalate beyond USD 400 million by 2030, assuming continued market penetration and competitive pricing.
  • Margins may face pressure from generic competition, necessitating cost optimization.

Investment and R&D Considerations

Limited innovation pipelines for milrinone suggest a reliance on existing formulations. Investment focus may shift toward developing safer, more stable, or combination therapies, indirectly impacting the market dynamics of milrinone lactate.

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Strategic Opportunities and Challenges

Opportunities:

• Expanding the scope of use through evidence-based guidelines and real-world data.
• Developing biosimilar and generic products to capture cost-sensitive markets.
• Entering emerging markets with localized regulatory strategies and partnerships.

Challenges:

• Competition from newer inotropes, such as levosimendan.
• Safety concerns and adverse effect profiles limiting adoption.
• Regulatory hurdles and reimbursement fluctuations.

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Conclusion

Milrinone lactate’s market trajectory is characterized by moderate growth, reinforced by the global rise of cardiovascular diseases and critical care procedures. Although facing challenges from safety concerns and competitive pressures, strategic positioning in emerging markets and the proliferation of generics will sustain its demand. Stakeholders should focus on optimizing manufacturing efficiencies, expanding clinical evidence, and navigating regulatory landscapes to leverage the full potential of this vital inotropic agent.

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Key Takeaways

• The global market for milrinone lactate is projected to grow at a CAGR of 4-5% through 2030, driven largely by rising cardiovascular disease prevalence.
• Market growth is bolstered by increased use in cardiac surgeries, critical care, and emerging markets’ expanding healthcare infrastructure.
• Competitive dynamics are heavily influenced by generic penetration, pricing strategies, and safety concerns influencing clinical adoption.
• Investment in clinical research and strategic partnerships in emerging regions represent key avenues for growth.
• Ongoing regulatory and safety considerations necessitate vigilant compliance and innovation to sustain market relevance.

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FAQs

1. What factors most significantly influence the market demand for milrinone lactate?
Demand is driven primarily by the rising incidence of heart failure worldwide, expansion of critical care facilities, and its established use during cardiac surgeries. Safety profiles and competition from alternative inotropes also impact adoption rates.

2. How does patent expiration affect the milrinone lactate market?
Patent expirations facilitate the entry of generic manufacturers, reducing prices and expanding accessibility but compressing profit margins for innovator companies.

3. Which regions are experiencing the fastest growth in milrinone lactate utilization?
Emerging markets in Asia-Pacific, particularly China and India, are experiencing rapid growth owing to increased healthcare expenditure, expanding ICU infrastructure, and a growing burden of CVD.

4. Are there promising pipeline developments or formulation innovations for milrinone?
Currently, the pipeline remains limited, with most efforts focused on manufacturing efficiencies and generic formulations. No significant novel delivery systems or formulations are publicly anticipated in the near term.

5. How do safety concerns impact the clinical use of milrinone?
Risks of arrhythmias and hypotension restrict its use in certain vulnerable populations, leading clinicians to consider alternative therapies, thereby impacting market share.

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Sources:
[1] World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
[2] MarketWatch. Global Milrinone Market Analysis and Forecast. 2022.
[3] U.S. FDA Drug Approvals Database. 2021.
[4] IQVIA. Pharma Market Reports. 2022.