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, West-ward Pharms Int, and Sanofi Aventis Us, and is included in twenty-seven 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:	27
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
University of Pennsylvania	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
Shandong	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	216373-001	Jan 23, 2023	AP	RX	No	No
Mylan Institutional	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	076428-001	Jun 16, 2003		DISCN	No	No
Gland Pharma Ltd	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	077190-001	Oct 31, 2006		DISCN	No	No
Baxter Hlthcare	MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	076259-001	Aug 8, 2002		DISCN	No	No
Meitheal	MILRINONE LACTATE	milrinone lactate	INJECTABLE;INJECTION	211671-001	Mar 24, 2020	AP	RX	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
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-001	Aug 9, 1994

MILRINONE LACTATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Milrinone Lactate

Introduction

Milrinone Lactate, a small molecule drug developed by Sanofi, has been a significant therapeutic option for the treatment of heart failure since its approval in 1987. This article delves into the market dynamics and financial trajectory of Milrinone Lactate, exploring its regulatory status, clinical use, competitive landscape, and financial implications.

Regulatory Status and Approval

Milrinone Lactate has undergone rigorous regulatory scrutiny, including priority review and designation as an orphan drug due to its potential benefits in treating heart failure, a condition characterized by the heart's inability to pump blood effectively[1].

Clinical Use and Efficacy

Milrinone Lactate is part of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity. It targets cGMP-PDE, an enzyme involved in the regulation of cyclic guanosine monophosphate (cGMP) levels, leading to vasodilation and improved cardiac contractility. This drug has been shown to improve cardiovascular function in various patient groups, including pediatric patients with septic shock and adults with heart failure[2][4].

Dosage and Administration

The administration of Milrinone Lactate involves a loading dose followed by a continuous infusion. The loading dose is typically 50 mcg/kg administered over 10 minutes, and the maintenance dose ranges from 0.375 to 0.75 mcg/kg/min. The drug can be diluted in various solutions such as 0.45% Sodium Chloride Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection[5].

Stability and Compatibility

Studies have shown that Milrinone Lactate is stable in the presence of many critical care drugs and in various intravenous solutions, including lactated Ringer's injection, 5% dextrose injection, and sodium chloride injections. This stability ensures its safe co-administration with other medications commonly used in critical care settings[3].

Competitive Landscape

The competitive landscape for drugs targeting cGMP-PDE is dynamic, with multiple companies focusing on small molecule drugs. Japan, China, and the United States are leading in drug development, with China showing notable progress. The market is expected to continue focusing on small molecule drugs, with potential competition from biosimilars[1].

Market Dynamics

Global Market

Milrinone Lactate has been approved and is used globally, with significant presence in the United States and China. The global market for heart failure treatments is growing, driven by an increasing prevalence of cardiovascular diseases and the need for effective therapeutic options.

Regional Focus

Countries like Japan, China, and the United States are at the forefront of drug development for cGMP-PDE targets. China's rapid progress in pharmaceutical research and development is expected to impact the market dynamics, potentially leading to new competitors and innovative treatments[1].

Future Opportunities

The future development of cGMP-PDE targets is expected to focus on small molecule drugs, with a potential shift towards biosimilars as patents expire. This could lead to increased competition and potentially lower prices, making treatments more accessible to a broader patient population.

Financial Trajectory

Revenue and Sales

Milrinone Lactate has been a revenue-generating drug for Sanofi since its approval. While exact financial figures are not publicly disclosed, the drug's widespread use and long-standing presence in the market indicate significant revenue generation.

Cost and Pricing

The cost of Milrinone Lactate can vary based on the region, healthcare system, and insurance coverage. However, it is generally considered a costly treatment due to its specialized nature and the critical care setting in which it is often administered.

Impact of Generic and Biosimilar Competition

As patents for Milrinone Lactate expire, the introduction of generic and biosimilar versions could significantly impact the financial trajectory. This competition could lead to reduced prices, affecting Sanofi's revenue but making the treatment more affordable for patients.

Clinical Trials and Research

Milrinone Lactate has been evaluated in numerous clinical trials, involving over 1600 patients with various forms of heart failure. These trials have demonstrated its efficacy and safety, contributing to its established position in the treatment of heart failure[4].

Patient Outcomes and Quality of Life

The drug has been shown to improve hemodynamic status, increase cardiac output, and reduce pulmonary capillary wedge pressure, thereby enhancing patients' quality of life. These improvements are crucial for managing heart failure and reducing the burden on healthcare systems[4].

Key Takeaways

• Regulatory Approval: Milrinone Lactate has undergone priority review and is designated as an orphan drug.
• Clinical Efficacy: It improves cardiovascular function by targeting cGMP-PDE.
• Market Dynamics: The global market is driven by increasing prevalence of heart failure, with significant competition from small molecule drugs and potential biosimilars.
• Financial Trajectory: Revenue generation is substantial, but future competition from generics and biosimilars could impact pricing and revenue.
• Patient Outcomes: The drug significantly improves hemodynamic status and quality of life for patients with heart failure.

FAQs

What is Milrinone Lactate used for?

Milrinone Lactate is primarily used for the treatment of heart failure, improving cardiovascular function by increasing cGMP levels and enhancing cardiac contractility and vasodilation[1].

How is Milrinone Lactate administered?

It is administered via a loading dose followed by a continuous intravenous infusion. The loading dose is typically 50 mcg/kg over 10 minutes, and the maintenance dose ranges from 0.375 to 0.75 mcg/kg/min[5].

Is Milrinone Lactate stable with other medications?

Yes, Milrinone Lactate has been shown to be stable in the presence of many critical care drugs and in various intravenous solutions[3].

What is the competitive landscape for Milrinone Lactate?

The competitive landscape includes multiple companies focusing on small molecule drugs targeting cGMP-PDE, with Japan, China, and the United States leading in drug development[1].

How does the introduction of generics and biosimilars affect Milrinone Lactate's financial trajectory?

The introduction of generics and biosimilars could lead to reduced prices, affecting Sanofi's revenue but making the treatment more affordable for patients.

What are the key benefits of Milrinone Lactate for patients?

Milrinone Lactate improves hemodynamic status, increases cardiac output, and reduces pulmonary capillary wedge pressure, thereby enhancing patients' quality of life[4].

Sources

1. An In-depth Analysis of Milrinone Lactate's R&D Progress and ... - Synapse Patsnap
2. Hemodynamic effects of i.v. milrinone lactate in pediatric patients ... - PubMed
3. Stability of milrinone lactate in the presence of 29 critical care drugs ... - PubMed
4. Milrinone Lactate Injection - Pfizer Labeling
5. Milrinone lactate injection VIAL Dosage and Administration - US - Pfizer Medical Information