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	020343-003	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

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
United Kingdom	2065642	5-(PYRIDINYL)-2-(1H)-PYRIDINONES USEFUL AS CARDIOTONIC AGENTS AND THEIR PREPARATION
Mexico	158257	PROCEDIMIENTO PARA PREPARAR UNA 2(1H)-PIRIDINONA
Austria	A95983
Norway	803550
Sweden	442398	5-(PYRIDINYL)-2(1H)-PYRIDINONER, FORFARANDE FOR FRAMSTELLNING AV DESSA SAMT EN KARDIOTONISK KOMPOSITION

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

Last updated: August 5, 2025

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Introduction

Primacor (mildronate) combined with Dextrose 5% in plastic containers represents a specialized pharmaceutical product focused on intensive care, cardiology, and hydration therapy. Market dynamics surrounding this formulation are shaped by technological, regulatory, and healthcare sector shifts. This analysis explores the evolving landscape, competitive positioning, regulatory influences, and the financial trajectory integral to evaluating investment and strategic considerations for stakeholders.

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Product Overview and Application

Primacor, primarily marketed in intravenous (IV) formulations with Dextrose 5%, caters to critical care interventions—including fluid resuscitation, electrolyte management, and drug delivery in hospital settings. The use of Dextrose 5% offers osmotic balance, caloric support, and compatibility with various medications, increasing its clinical utility. The plastic container enhances safety, convenience, and supply chain logistics, aligning with modern pharmaceutical packaging trends.

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Market Dynamics Analysis

1. Global Market Landscape

The global IV fluids market, projected to reach USD 22.2 billion by 2028, is expanding at a CAGR of approximately 6.2% (Research and Markets, 2022). The growth drivers include rising prevalence of chronic diseases, emerging markets’ healthcare infrastructure expansion, and increased hospitalizations. Primacor’s Dextrose 5% formulation occupies a niche within this broad market, with a focus on critical care and specialized hospital use.

2. Regulatory Environment

Regulatory pathways significantly influence market access. The U.S. Food and Drug Administration (FDA) classifies Primacor formulations under hospital-grade IV solutions, requiring stringent safety and efficacy data. Post-approval, adherence to Good Manufacturing Practice (GMP), serialization, and track-and-trace requirements augment compliance costs but contribute to quality assurance. Additionally, evolving standards for single-use plastics and container safety (e.g., plastic leaching concerns) will impact manufacturing protocols and costs.

3. Competitive Landscape

The competitive environment features numerous global and regional players manufacturing Dextrose 5% solutions, such as Baxter, B. Braun, and Fresenius Kabi. While these companies predominantly supply in glass or alternative plastic containers, differentiation centers around container material, ease of use, safety features, and packaging innovations. Primacor’s unique positioning may leverage proprietary formulation or packaging design, provided regulatory approval is obtained.

4. Healthcare Sector Trends

Advancements toward personalized medicine, rapid infusion therapies, and automation in hospitals influence demand. The shift toward prefilled, ready-to-use plastic containers simplifies administration and minimizes contamination risks. A trend toward environmentally sustainable packaging may pressure manufacturers to innovate biodegradable plastics or alternative materials, potentially altering cost structures and market models.

5. Supply Chain and Pricing Dynamics

Supply chain resilience has become critical, especially amid recent disruptions caused by global crises like COVID-19. Concentration of raw material suppliers for plastics and pharmaceuticals can introduce volatility in costs. Pricing strategies must balance production costs, regulatory costs, and hospital procurement power. Margins may be tight owing to commoditization of IV solutions; thus, value-added features or branding are instrumental for profitability.

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Financial Trajectory

1. Revenue Projections

Assuming market penetration in high-requirement healthcare facilities and incremental expansion into emerging markets, revenue forecasts suggest an annual growth rate of 4-6% over the next five years. The increasing adoption of specialized IV solutions and hospital preference for prefilled plastic containers underpin this projection.

2. Cost Structure and Margins

Major costs include raw materials (medical-grade plastics, active pharmaceutical ingredients), manufacturing, regulatory compliance, and distribution. Adoption of innovative packaging may elevate initial capital expenditure but reduce per-unit costs through scale efficiencies. Operating margins are expected to remain under pressure initially but could improve with product differentiation and operational efficiencies.

3. Investment and R&D Outlook

Further investment in research targeting environmentally sustainable containers and novel formulations could unlock new markets. Collaborations with medical device companies and hospitals for customized packaging could enhance market share. R&D expenditure as a percentage of sales remains essential to maintain compliance and innovation advantage.

4. Risks and Challenges

• Regulatory hurdles delaying market entry or expansions.
• Competition from generic or alternative formulations.
• Volatility in raw material costs.
• Environmental regulations impacting packaging materials.
• Fluctuating hospital procurement budgets.

5. Potential for Market Expansion

Emerging markets present growth opportunities, driven by expanding healthcare infrastructure and rising healthcare expenditure. Additionally, increasing hospital autonomy may favor branded solutions with proven safety and efficacy profiles.

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Strategic Considerations

For stakeholders, successful navigation of this market hinges on incorporating regulatory agility, cost management, and innovation. Establishing early regulatory approval, investing in sustainable packaging, and forming strategic partnerships could significantly enhance financial trajectory and market positioning.

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Key Takeaways

• The global IV fluids market's expansion offers growth prospects for Primacor in Dextrose 5% in plastic containers, especially with the rising demand for hospital-grade solutions.
• Regulatory compliance and sustainable packaging present both challenges and opportunities, influencing product development and costs.
• Competition from established players necessitates differentiation through formulation, packaging, and clinical positioning.
• Financial outlook indicates moderate but steady growth, with margins sensitive to raw material costs and regulatory approval timelines.
• Strategic investments in innovation and emerging markets are essential for capturing new demand and ensuring long-term profitability.

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FAQs

1. What drives demand for Primacor in Dextrose 5% solutions?
Demand stems from increased use in critical care, fluid management, and hydration therapy, coupled with hospital's preference for ready-to-use plastic containers that enhance safety and convenience.

2. How does regulatory approval impact Primacor’s market trajectory?
Regulatory approval determines market access and influences time-to-market, with strict compliance requirements impacting development costs and product rollout speed.

3. What are the key competitive factors in this market segment?
Product safety, packaging innovation, regulatory compliance, cost-efficiency, and supply chain reliability are pivotal competitive factors.

4. How do environmental concerns influence packaging choices?
Environmental regulations and hospital sustainability initiatives favor biodegradable plastics and eco-friendly packaging, potentially increasing costs but offering branding advantages.

5. What are the main risks associated with the financial trajectory?
Market entry delays, raw material cost volatility, regulatory hurdles, and intense competition pose significant risks to the expected growth and profitability.

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Sources

[1] Research and Markets. "IV Fluids Market by Product, Application, and Region – Global Forecast to 2028." 2022.