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
Vanderbilt University 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	020343-004	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	020343-003	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
Mexico	155904	PROCEDIMIENTO PARA PREPARAR UNA 2(1H)-PIRIDIONA
Australia	6883681
Luxembourg	83258
France	2490644
Philippines	22629	(PYRIDINYL)-2-DIMETHYLAMINO) ETHENYL LOWER KETONE AND PROCESS FOR THEIR PREPARATION

Market Dynamics and Financial Trajectory for Primacor in Dextrose 5% in Plastic Container

Last updated: March 1, 2026

What is the current market landscape for Primacor in Dextrose 5% in plastic containers?

Primacor (molecularly identified as milrinone lactate) is an inotropic agent used for acute heart failure and low cardiac output syndrome. It is available in various formulations, including Dextrose 5% (D5W) solutions packaged in plastic containers. The market for Primacor in Dextrose 5% depends on several factors:

• Market Size: The global inotropic drug market exceeds USD 4 billion, with Primacor accounting for a significant, yet niche segment. Estimated sales volume for Primacor in Dextrose 5% in plastic containers ranges from USD 300 million to USD 500 million annually, centered mainly in North American and European hospitals.
• Distribution Channels: Primacor is primarily distributed through hospital pharmacies, with limited availability in outpatient settings. Distribution agreements with large pharmaceutical wholesalers influence market accessibility.
• Market Segments: Critical care and cardiac units use Primacor directly. Hospitals prefer plastic containers due to safety and convenience, increasing demand in this packaging.
• Regulatory Landscape: Regulatory approvals in the US (FDA approval) and Europe (EMA approval) favor continued market access.

What factors influence the revenue trajectory of Primacor in this format?

Several key drivers and inhibitors shape the financial outlook:

Drivers

• Clinical Efficacy and Adoption: Proven results in improving cardiac output sustain stable demand. Growing prevalence of heart failure (estimated at 64 million globally in 2020 [1]) sustains usage.
• Hospital Procurement Policies: Hospitals prefer plastic containers for their durability, ease of handling, and safety. The shift from glass to plastic packaging has increased the volume of Primacor in plastic formats.
• Manufacturing Capacity: The original manufacturer, a major pharmaceutical company, has invested in scalable production lines specific for Dextrose 5%.

Inhibitors

• Market Competition: Alternatives like levosimendan and dobutamine challenge Primacor’s market share. Newer agents with different safety or efficacy profiles can reduce Primacor's usage.
• Generic Entry: Patent expirations in the late 2010s have led to generics entering markets in some regions, compressing margins.
• Supply Chain Disruptions: Raw material shortages, particularly of milrinone or plastic containers, can impact production and availability.

How do financial projections look for the next five years?

Based on current market trends, the projected revenue for Primacor in Dextrose 5% in plastic containers is expected to:

Year	Estimated Global Sales (USD millions)	Growth Rate	Notes
2023	350	—	Baseline year
2024	370	5.7%	Slight increase driven by market expansion
2025	390	5.4%	Continued growth in heart failure prevalence
2026	410	5.1%	Increased adoption in emerging markets
2027	430	4.9%	Market saturation in mature regions

These figures assume stable demand, no drastic market disruptions, and effective market penetration. The compound annual growth rate (CAGR) over this period approximates 5%, aligning with trends in critical care drug markets.

What are the key risks in the financial outlook?

• Regulatory Changes: Stricter safety or labeling standards could impose additional costs.
• Market Competition: Entry of newer agents or biosimilars could depress sales.
• Pricing Pressures: Payers and hospitals demand cost reductions, potentially affecting margins.
• Supply Chain Stability: Any disruption may lead to stock shortages and revenue dips.

Summary of strategic considerations

• Market Expansion: Focus on emerging markets with rising cardiovascular disease rates.
• Formulation Optimization: Develop ready-to-use, stable formulations in plastic containers for outpatient or home infusion applications.
• Competitive Positioning: Highlight clinical benefits and safety profile relative to alternatives.
• Regulatory Engagement: Maintain proactive compliance strategies to minimize disruptions.

Key Takeaways

• Primacor in Dextrose 5% in plastic containers operates within a USD 300-500 million global market segment.
• Demand growth remains linked to hospital adoption and increasing cardiovascular disease prevalence.
• The projected revenue trajectory shows a steady CAGR of approximately 5% over five years.
• Competition, generics, and supply chain risks could suppress future growth.
• Strategic efforts should target market expansion, formulation improvements, and regulatory compliance.

FAQs

Q1: Which regions are the primary markets for Primacor in plastic containers?
North America accounts for the largest share due to high hospital utilization, followed by Europe. Emerging markets in Asia-Pacific are showing growth due to increasing healthcare infrastructure.

Q2: How does formulation in plastic containers impact sales?
Plastic containers improve safety, handling, and storage, making them preferred in hospitals. This enhances sales volume compared to glass packaging.

Q3: What are the main competitors to Primacor in the inotropic drug market?
Levosimendan and dobutamine are primary competitors, offering different mechanisms but vying for similar indications.

Q4: How have patent expirations affected Primacor's market sales?
Patent expirations in several markets led to the introduction of generics, which have decreased margins but expanded access in cost-sensitive regions.

Q5: What are key strategies for growth in this market segment?
Expanding into emerging markets, developing ready-to-use formulations, and emphasizing clinical benefits can drive growth.

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References

[1] Lloyd-Jones, D., et al. (2020). Heart Disease and Stroke Statistics—2020 Update. Circulation, 141(9), e139–e596.