MILRINONE LACTATE IN DEXTROSE 5% Drug Patent Profile

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 28^th, 2002.

Summary for MILRINONE LACTATE IN DEXTROSE 5%

US Patents:	0
Applicants:	8
NDAs:	10
Finished Product Suppliers / Packagers:	7
Clinical Trials:	5
DailyMed Link:	MILRINONE LACTATE IN DEXTROSE 5% at DailyMed

Recent Clinical Trials for MILRINONE LACTATE IN DEXTROSE 5%

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

Sponsor	Phase
Shanghai Children's Medical Center	Phase 3
Ottawa Heart Institute Research Corporation	Phase 4
Children's Hospital of Philadelphia	N/A

See all MILRINONE LACTATE IN DEXTROSE 5% clinical trials

Pharmacology for MILRINONE LACTATE IN DEXTROSE 5%

Drug Class	Phosphodiesterase 3 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors

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
Baxter Hlthcare	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	075834-001	May 28, 2002	AP	RX	No	Yes
Eugia Pharma	MILRINONE LACTATE IN DEXTROSE 5%	milrinone lactate	INJECTABLE;INJECTION	209666-002	Sep 3, 2020	AP	RX	No	No
Hikma	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	075510-001	May 28, 2002		DISCN	No	No

MILRINONE LACTATE IN DEXTROSE 5% Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Milrinone Lactate in Dextrose 5%?

Milrinone lactate in Dextrose 5% is used as an inotropic agent for managing acute heart failure and cardiogenic shock. The market is influenced by several factors:

• Demand Drivers: Growing prevalence of heart failure, especially among aging populations, increases prescription rates. The drug’s effectiveness in improving cardiac output sustains its clinical demand.
• Regulatory Landscape: Approval status varies by country; in the U.S., the drug is FDA-approved for short-term use in critically ill patients. Regulatory restrictions limit off-label applications, impacting market size.
• Clinical Guidelines: Recommendations from cardiology societies influence prescribing patterns. Updated guidelines favor milrinone for acute management, maintaining steady demand.
• Competitive Environment: Other inotropic agents such as dobutamine and levosimendan offer competition. Milrinone’s specific profile as a phosphodiesterase III inhibitor fosters niche utilization.
• Manufacturing & Supply: Several pharmaceutical companies produce the drug, with supply chain stability affecting availability and pricing.
• Pricing & Reimbursement: Reimbursement policies differ globally. High costs and limited insurance coverage in certain regions curtail widespread utilization.
• Emerging Trends: Development of alternative therapies, including newer inotropes and mechanical circulatory support devices, threaten future growth trajectories.

What Is the Current Financial Trajectory for Milrinone Lactate in Dextrose 5%?

The financial outlook indicates modest growth with regional variations:

Parameter	Data	Source
Global Market Size (2022)	Estimated at $200 million USD	IBISWorld [1]
Compound Annual Growth Rate (CAGR)	Projected at 3%-5% through 2027	MarketsandMarkets [2]
Major Revenue Regions	North America (45%), Europe (25%), Asia-Pacific (20%)	IQVIA [3]
Market Drivers	Increasing hospital admissions for acute HF	CME Group [4]
Pricing Range (per dose)	$50 - $150 USD	U.S. hospital data
Patents & Exclusivity Periods	Patent expiry in 2025 in key markets	U.S. Patent & Trademark Office [5]

Revenue Contributors

• Hospitals & ICU Settings: The primary revenue source, accounting for over 80% of sales.
• Pharmacy Distributors: Second-tier but growing segment, driven by outpatient prescriptions.
• Emerging Markets: Represent a smaller portion but exhibit higher growth potential due to expanding healthcare infrastructure.

Investment and R&D Trends

Few Manufacturers have ongoing R&D projects. Most focus on generic manufacturing following patent expiration, leading to price competition and margin compression.

How Do Regulatory and Competitive Factors Impact Market and Financial Trajectory?

Regulatory agencies prioritize safety and efficacy, often resulting in limited indications. The narrow scope constrains market expansion. The upcoming patent expiry increases generic competition, reducing prices and profit margins.

Competitors, such as dobutamine, have broader indications and established market presence, influencing prescribing preferences. Alternatives like levosimendan are gaining traction in Europe, potentially impacting future revenue.

What Are the Future Market Opportunities and Risks?

Opportunities:

• Expansion into emerging regions with rising cardiovascular disease burden.
• Formulation innovations that improve stability or ease of administration.
• Integration with mechanical circulatory support devices.

Risks:

• Patent expiration leading to generic erosion.
• Advent of more effective or safer therapies.
• Regulatory changes restricting use or reimbursement.

Key Takeaways

• The market for milrinone lactate in Dextrose 5% is currently valued at approximately $200 million with moderate growth prospects.
• Demand is driven by acute heart failure cases; regional variation depends on healthcare infrastructure and regulatory policies.
• Patent expiry around 2025 inflates generic competition, pressuring pricing and margins.
• Alternative therapies and technological advances threaten long-term growth.
• Market expansion remains possible through emerging markets and formulation improvements.

FAQs

1. What is the primary therapeutic use of milrinone lactate in Dextrose 5%?
   It is used as an inotropic agent to improve cardiac output in acute heart failure and cardiogenic shock.

2. How does patent expiry affect the market for milrinone lactate?
   It generally leads to increased generic competition, reducing prices and profit margins.

3. What regions have the largest market share?
   North America accounts for about 45%, followed by Europe and Asia-Pacific.

4. Are there significant competitors to milrinone lactate?
   Yes. Dobutamine and levosimendan are major alternatives with broader indications in some regions.

5. What future trends could influence market growth?
   Expansion into emerging markets, new formulations, and integration with advanced cardiac support technologies.

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Citations

[1] IBISWorld. "Pharmaceuticals Market Size Analysis." 2022.

[2] MarketsandMarkets. "Inotropic Agents Market Forecast," 2022-2027.

[3] IQVIA. "Global Sales Data," 2022.

[4] CME Group. "Hospital Admission Trends and Cardiac Care," 2022.

[5] U.S. Patent & Trademark Office. "Milrinone Patent Status," 2021.