PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Primacor In Dextrose 5% In Plastic Container, and what generic alternatives are available?

Primacor In Dextrose 5% In Plastic Container is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER 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 Primacor In Dextrose 5% In Plastic Container

A generic version of PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as milrinone lactate by FRESENIUS KABI USA on May 28^th, 2002.

Summary for PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	11
DailyMed Link:	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Mahidol University	Phase 2
Zagazig University	Phase 4
University of Kansas Medical Center	Phase 1

See all PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-001	Aug 9, 1994		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-004	Aug 9, 1994		DISCN	Yes	No

Expired US Patents for PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	020343-002	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

International Patents for PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3044568
South Africa	8107237
Spain	8301920

Market Dynamics and Financial Trajectory for PRIMACOR (Milrinone Lactate) in Dextrose 5% in Plastic Container

Introduction

PRIMACOR, known generically as milrinone lactate, is a cardiac agent used for the short-term treatment of acute decompensated heart failure. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its history, usage, market performance, and future prospects.

Historical Context

Milrinone was first synthesized in the 1980s at the Sterling Winthrop Research Institute and was approved by the FDA on December 31, 1987. Initially marketed under the trademark PRIMACOR by Sanofi-Aventis US, it has since been discontinued by the original manufacturer but remains available through generic formulations[4].

Clinical Use and Indications

PRIMACOR is indicated for the short-term (48 hours or less) treatment of patients with acute decompensated heart failure. It acts as a positive inotrope and vasodilator, enhancing cardiac output and reducing pulmonary capillary wedge pressure without significant chronotropic effects[1][2][4].

Market Structure

The market for PRIMACOR is now dominated by generic versions, which are available in various formulations, including pre-mixed bags of 5% dextrose injection. These formulations are offered by multiple pharmaceutical companies, contributing to a competitive market environment[3].

Product Formulations

• PRIMACOR is available in pre-mixed flexible containers with concentrations of 200 mcg/mL in 5% Dextrose Injection, in volumes of 100 mL and 200 mL[1][3].
• These formulations are ready-to-use and do not require dilution prior to administration[2].

Dosage and Administration

The drug is administered intravenously, typically starting with a loading dose followed by a continuous infusion. The standard infusion rate ranges from 0.375 mcg/kg/min to 0.75 mcg/kg/min, with adjustments based on patient response and renal function[2].

Pharmacokinetics and Pharmacodynamics

PRIMACOR has a volume of distribution of approximately 0.38-0.45 liters/kg and a terminal elimination half-life of about 2.3-2.4 hours. It is primarily excreted through the urine, with significant binding to human plasma proteins[1].

Market Performance

Historical Sales

Despite being discontinued by its original manufacturer, PRIMACOR continues to be used due to its efficacy in treating acute heart failure. The transition to generic formulations has maintained its presence in the market, although the sales figures are not as robust as during its peak under Sanofi-Aventis US.

Current Market Trends

The cardiac drug market is highly competitive, with various inotropic agents available. However, PRIMACOR's unique mechanism of action and established clinical use continue to support its market position. The availability of generic versions has made the drug more accessible and affordable, contributing to its sustained market presence.

Financial Trajectory

Pricing

The pricing of PRIMACOR has become more competitive with the entry of generic formulations. For instance, the cost per milliliter of milrinone in 5% dextrose injection can range from $1.45 to $1.6 USD per milliliter, depending on the supplier and volume[4].

Revenue Streams

The revenue generated from PRIMACOR is now primarily driven by generic sales. The drug's use in hospitals and intensive care units ensures a steady demand, although the revenue per unit has decreased due to generic competition.

Regulatory and Safety Considerations

Safety Profile

PRIMACOR is associated with several safety concerns, including increased risk of ventricular arrhythmias and sudden death, particularly with long-term use. Patients must be closely monitored with continuous electrocardiographic monitoring[1].

Regulatory Status

The drug is approved for short-term use only, and its long-term use is not recommended due to the associated risks. Regulatory bodies continue to monitor its use and safety profile closely.

Future Prospects

Market Growth

The demand for cardiac agents is expected to grow due to increasing incidence of heart failure. However, PRIMACOR's market share may be influenced by the development of newer, safer alternatives.

Competitive Landscape

The competitive landscape is likely to remain intense, with multiple generic manufacturers competing for market share. Innovations in drug delivery and safety profiles of competing drugs could impact PRIMACOR's market position.

Key Takeaways

• Historical Context: PRIMACOR was first approved in 1987 and is now available in generic formulations.
• Clinical Use: It is used for the short-term treatment of acute decompensated heart failure.
• Market Structure: The market is dominated by generic versions, contributing to a competitive environment.
• Financial Trajectory: Revenue is driven by generic sales, with competitive pricing affecting profit margins.
• Regulatory and Safety Considerations: The drug has a significant safety profile and is subject to regulatory monitoring.

FAQs

What is PRIMACOR used for?

PRIMACOR is used for the short-term treatment of patients with acute decompensated heart failure.

How is PRIMACOR administered?

PRIMACOR is administered intravenously, typically starting with a loading dose followed by a continuous infusion.

What are the common side effects of PRIMACOR?

Common side effects include increased risk of ventricular arrhythmias and sudden death, particularly with long-term use.

Is PRIMACOR available in generic form?

Yes, PRIMACOR is available in generic formulations from multiple manufacturers.

What is the recommended infusion rate for PRIMACOR?

The standard infusion rate ranges from 0.375 mcg/kg/min to 0.75 mcg/kg/min, with adjustments based on patient response and renal function.

Sources

1. PRIMACOR - accessdata.fda.gov
2. Primacor Dosage Guide - Drugs.com
3. Milrinone Lactate in 5% Dextrose Injection Premixed Bag - Eugia US
4. Milrinone: Uses, Interactions, Mechanism of Action | DrugBank Online