MILRINONE LACTATE - Generic Drug Details

What are the generic drug sources for milrinone lactate and what is the scope of patent protection?

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
Children's Hospital of Philadelphia	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
B Braun	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	076414-001	Aug 18, 2004		DISCN	No	No
Caplin	MILRINONE LACTATE IN DEXTROSE 5%	milrinone lactate	INJECTABLE;INJECTION	219170-002	Sep 2, 2025	AP	RX	No	No
Hikma Farmaceutica	MILRINONE LACTATE IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	090038-001	Jan 21, 2010	AP	RX	No	No
Hikma Farmaceutica	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	077966-001	Dec 3, 2010	AP	RX	No	Yes
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-001	Aug 9, 1994		DISCN	Yes	No
Hikma Farmaceutica	MILRINONE LACTATE IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	090038-002	Jan 21, 2010	AP	RX	No	No
Baxter Hlthcare Corp	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	076427-001	Sep 21, 2004		DISCN	No	No

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	020343-001	Aug 9, 1994	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: February 12, 2026

Overview

Milrinone lactate is a phosphodiesterase-3 inhibitor used as an inotropic agent for short-term treatment of acute heart failure and cardiogenic shock. It is administered via intravenous infusion, primarily in hospital settings. The drug’s market is influenced by hospital protocols, patient demographics, and competitive landscape.

Market Size and Growth

The global pharmacy market for inotropic agents, including milrinone lactate, was valued at approximately $750 million in 2022. It is projected to reach around $1 billion by 2028, growing at a compound annual growth rate (CAGR) of 5.5% (2022-2028).

This growth is primarily driven by increasing incidences of acute heart failure. The American Heart Association reports that about 6.2 million adults in the United States experience heart failure, with hospitalizations increasing annually. Similar patterns occur across Europe and Asia, expanding demand for inotropic therapies.

Market Segmentation

Milrinone lactate primarily competes in hospital environments, used during critical care. The segments include:

• Acute heart failure management
• Postoperative cardiac support
• Cardiogenic shock treatment

While its use varies globally based on clinical guidelines and hospital preferences, the drug remains an essential component of intensive care protocols.

Competitive Landscape

Key competitors include:

• Vasopressor and inotropic agents: Dobutamine, dopamine, levosimendan
• Alternative therapies: Mechanical circulatory support devices

Milrinone's market share faces pressure from newer drugs like levosimendan, approved in select markets, and from improved mechanical circulatory support that reduces reliance on pharmacological agents.

Pricing Trends

Pricing for milrinone lactate varies geographically. The average listed price per 10 mg vial in the U.S. ranges from $50 to $70. Hospitals often negotiate bulk purchasing discounts, reducing unit costs.

In markets outside the U.S., prices are generally lower, influenced by healthcare policies and procurement strategies.

Regulatory and Commercial Factors

Milrinone lactate has long-standing regulatory approval in multiple jurisdictions. However, recent trends include:

• Movement towards generic versions following patent expirations
• Increased adoption of biosimilars or alternative inotropic agents
• Pathways for off-label use, which could affect market size

Financial Trajectory

The financial outlook for milrinone lactate depends on:

• Clinical adoption trends: As hospitals favor newer or less invasive alternatives, growth may plateau or decline.
• Patent landscape: Patent expirations in key markets open opportunities for generics, reducing prices and profit margins.
• Regulatory approvals: New indications or formulations could stimulate growth.

For a major manufacturer, revenues derived from milrinone lactate could decline by 2-4% annually post-patent expiry unless offset by expanded indications or market penetration. Conversely, generics entering the market could reduce average selling prices by 30-50% over 3-5 years.

Investment Considerations

Investors should monitor:

• The pipeline of novel inotropic agents
• Regulatory decisions regarding biosimilars
• Hospital adoption rates of mechanical circulatory support
• Regional healthcare policies influencing drug procurement

Key Takeaways

• Market size projected to reach $1 billion globally by 2028 with a CAGR of 5.5%
• Dominant in hospital settings treating acute heart failure and cardiogenic shock
• Competition from newer pharmacological agents and mechanical devices influences growth
• Pricing varies by region, with potential for significant cost reduction due to generics
• Patent expirations and regulatory changes present both risk and opportunity for the financial trajectory

FAQs

1. What factors limit the growth of milrinone lactate?
   Adoption of mechanical circulatory support systems and newer inotropic agents reduce reliance on milrinone, constraining growth.

2. How do patent expirations affect market revenue?
   Patents expiring typically lead to generic entries, decreasing prices by up to 50% and reducing revenues unless new indications or formulations are developed.

3. Are there ongoing clinical trials for milrinone lactate?
   Most development focuses on new delivery methods or combination therapies; significant new trials explicitly for milrinone identify limited recent activity.

4. What regional differences influence market size?
   North America leads due to high hospitalization rates for heart failure, with lower prices and varied adoption in Europe and Asia.

5. How does the competitive landscape impact profitability?
   Competition from generics and alternative therapies compresses profit margins, demanding cost management and innovation.

Sources

[1] Grand View Research. (2022). "Inotropic Agents Market Size, Share & Trends."
[2] American Heart Association. (2022). Heart Failure Facts & Figures.
[3] U.S. Food and Drug Administration. (2022). Milrinone approval and patent details.