PRIMACOR Drug Patent Profile

When do Primacor patents expire, and when can generic versions of Primacor launch?

Primacor is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in PRIMACOR 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

A generic version of PRIMACOR was approved as milrinone lactate by FRESENIUS KABI USA on May 28^th, 2002.

Summary for PRIMACOR

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	131
Clinical Trials:	11
Patent Applications:	3,824
DailyMed Link:	PRIMACOR at DailyMed

Recent Clinical Trials for PRIMACOR

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

Sponsor	Phase
Mahidol University	Phase 2
Zagazig University	Phase 4
Lipscomb University	Phase 1

See all PRIMACOR clinical trials

US Patents and Regulatory Information for PRIMACOR

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	milrinone lactate	INJECTABLE;INJECTION	019436-001	Dec 31, 1987		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994		DISCN	Yes	No
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-001	Aug 9, 1994		DISCN	Yes	No

Expired US Patents for PRIMACOR

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

International Patents for PRIMACOR

See the table below for patents covering PRIMACOR around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	536354
Luxembourg	83258
Germany	3044568

PRIMACOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PRIMACOR (Milrinone Lactate)

Introduction

PRIMACOR, also known as milrinone lactate, is a pharmaceutical drug used primarily in the treatment of congestive heart failure and other cardiac conditions. It functions as a positive inotrope and vasodilator, offering unique therapeutic benefits. Here, we will delve into the market dynamics and financial trajectory of PRIMACOR, examining its development, usage, and economic impact.

Development and Approval

PRIMACOR was developed and approved by the FDA for use in patients with heart failure. The drug's approval was based on extensive clinical trials that demonstrated its efficacy in improving cardiac output, reducing pulmonary capillary wedge pressure, and enhancing diastolic function without significantly increasing heart rate or myocardial oxygen consumption[1][4].

Market Positioning

PRIMACOR is positioned as a specialized treatment for heart failure, particularly for patients who require immediate hemodynamic improvement. Its unique mechanism of action, involving the inhibition of peak III cAMP phosphodiesterase isozyme, sets it apart from other inotropes like digitalis glycosides and catecholamines[4].

Competitive Landscape

The market for heart failure treatments is highly competitive, with various drugs and therapies available. However, PRIMACOR's distinct pharmacological profile gives it a niche in the market. The rapid entry of follow-on drugs in the pharmaceutical industry, as observed in other therapeutic classes, suggests that competition could increase over time. However, the specific needs of heart failure patients often require tailored treatments, making PRIMACOR a valuable option despite the presence of other drugs[3].

Dosage and Administration

The dosage of PRIMACOR is critical to its market dynamics. It is administered as an intravenous infusion, with a recommended dosage range of 0.375 to 0.75 mcg/kg/min. The drug's pharmacokinetics, including its volume of distribution, elimination half-life, and clearance, are well-defined, which helps in precise dosing and monitoring[2][4].

Economic Impact

The economic impact of PRIMACOR is multifaceted:

Cost of Treatment

The cost of PRIMACOR can be significant due to its specialized nature and the need for continuous intravenous administration. However, the drug's ability to improve hemodynamic function and reduce the need for other interventions can lead to cost savings in the long term.

Hospitalization and Mortality Rates

Clinical trials have shown that while PRIMACOR can improve symptoms and hemodynamic function in the short term, long-term oral use has been associated with increased risks of hospitalization and death, particularly in patients with severe heart failure. This has implications for healthcare costs and resource allocation[1].

Monitoring and Adverse Effects

The need for continuous monitoring due to potential adverse effects such as ventricular arrhythmias adds to the overall cost of treatment. Despite these challenges, the drug remains a valuable option for managing acute heart failure[4].

Financial Trajectory

Revenue Generation

The revenue generated by PRIMACOR is influenced by its prescription rates, dosage regimens, and the duration of treatment. Given its use in critical care settings, the drug tends to generate significant revenue, particularly in hospitals and intensive care units.

Market Trends

The market for heart failure treatments is growing due to an increasing prevalence of cardiovascular diseases. This trend is expected to continue, driving demand for drugs like PRIMACOR. However, the drug's long-term use has been limited by its association with increased mortality and hospitalization rates, which can impact its financial trajectory[1].

Pricing Strategies

Pricing strategies for PRIMACOR are influenced by its therapeutic benefits, competition, and regulatory environments. The drug's unique benefits and the lack of direct competitors in its specific therapeutic niche allow for a premium pricing strategy.

Regulatory Considerations

PRIMACOR is subject to various regulatory requirements, including those related to its use in renally impaired patients and the need for careful monitoring of its adverse effects. These regulations can impact its market dynamics and financial performance by influencing prescribing practices and patient safety protocols[2][4].

Conclusion

PRIMACOR plays a critical role in the management of congestive heart failure, offering immediate hemodynamic improvements and unique therapeutic benefits. However, its market dynamics and financial trajectory are complex, influenced by factors such as dosage regimens, adverse effects, and regulatory considerations. Understanding these elements is crucial for healthcare providers, pharmaceutical companies, and investors.

Key Takeaways

• Therapeutic Benefits: PRIMACOR is a positive inotrope and vasodilator with significant hemodynamic benefits.
• Market Positioning: It occupies a niche in the heart failure treatment market due to its unique mechanism of action.
• Economic Impact: The drug's cost, impact on hospitalization rates, and need for monitoring affect its economic footprint.
• Financial Trajectory: Revenue is driven by prescription rates and treatment duration, but long-term use is limited by safety concerns.
• Regulatory Considerations: Strict monitoring and dosage adjustments are necessary, especially in renally impaired patients.

FAQs

Q: What is the primary use of PRIMACOR in clinical settings? A: PRIMACOR is primarily used to treat congestive heart failure by improving cardiac output and reducing pulmonary capillary wedge pressure.

Q: How does PRIMACOR differ from other inotropes? A: PRIMACOR is distinct due to its inhibition of peak III cAMP phosphodiesterase isozyme, which is different from the mechanisms of digitalis glycosides and catecholamines.

Q: What are the common adverse effects associated with PRIMACOR? A: Common adverse effects include ventricular arrhythmias, hypotension, and headache. Severe effects can include ventricular fibrillation and supraventricular arrhythmias.

Q: How is PRIMACOR administered? A: PRIMACOR is administered as an intravenous infusion, with a recommended dosage range of 0.375 to 0.75 mcg/kg/min.

Q: What are the implications of long-term oral use of PRIMACOR? A: Long-term oral use of PRIMACOR has been associated with increased risks of hospitalization and death, particularly in patients with severe heart failure.

Sources

1. PRIMACOR - accessdata.fda.gov
2. Primacor Dosage Guide - Drugs.com
3. The economics of follow-on drug research and development - PubMed
4. D:\PRIMACOR PM pristine 04-01-15.wpd