CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cardene In 5.0% Dextrose In Plastic Container, and when can generic versions of Cardene In 5.0% Dextrose In Plastic Container launch?

Cardene In 5.0% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cardene In 5.0% Dextrose In Plastic Container

A generic version of CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
DailyMed Link:	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

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

Sponsor	Phase
Boston Medical Center	Phase 4
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
University of Cincinnati	Phase 2

See all CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Paragraph IV (Patent) Challenges for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	Injection	nicardipine hydrochloride	2.5 mg/mL, 10 mL Ampoules	019734	1	2006-12-27

US Patents and Regulatory Information for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No			Y
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No			Y

International Patents for CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	334898
Austria	334902
Austria	A138874
Austria	A824375
Australia	6565574

Market Dynamics and Financial Trajectory for Cardene 5.0% Dextrose in Plastic Container

Last updated: January 17, 2026

Executive Summary

This report provides an exhaustive analysis of the market landscape, competitive forces, and financial prospects for Cardene 5.0% Dextrose in Plastic Container. As a medical infusion product, it operates within the broader intravenous (IV) fluid market, exhibiting specific growth drivers, challenges, and profitability indicators. Key insights reveal steady demand driven by hospital use, evolving regulations affecting packaging, and competition from generic and branded alternatives. The financial forecast indicates a stable trajectory with potential for growth contingent upon regulatory, technological, and market access factors.

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Market Overview: Cardene 5.0% Dextrose in Plastic Container

Product Description

• Active Ingredient: Dextrose 5.0%
• Formulation: Intravenous infusion, plastic (polyethylene or polypropylene) container
• Indications: Fluid replenishment, caloric supplementation, metabolic support in hospital settings

Market Segmentation

Segment	Details	Share (%) (2022 est.)
End-User	Hospitals (acute care, ICUs), clinics, long-term care	85
Geography	North America (45%), Europe (25%), Asia-Pacific (20%), ROW (10)

Regulatory Context

• FDA (U.S.), EMA (EU), and other agencies enforce strict standards for infusion products.
• Packaging requirements increasingly favor plastic safety and stability.
• Reimbursement policies favor hospital procurement, influencing sales volume.

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Market Dynamics

What are the Key Growth Drivers?

1. Hospital Demand & ICU Utilization: Rising global hospitalization rates and ICU admissions sustain demand.
2. Aging Population & Chronic Disease Management: Elderly populations require IV therapies for conditions like malnutrition, diabetes complications.
3. Regulatory Approvals & Safety Standards: Shift toward prefilled, sterile, safe plastic containers enhances market acceptance.
4. Technological Advances in Plastic Packaging: Innovations reducing leaching and preserving drug stability boost market share.
5. Global Expansion: Emerging markets exhibiting increasing healthcare infrastructure investments contribute to demand growth.

What Are the Challenges?

• Intense Competition: Coupled with generics and multiple suppliers limiting pricing power.
• Pricing Pressures & Reimbursement Rates: Healthcare payers negotiating lower costs impact profitability.
• Supply Chain Disruptions: Raw material shortages (plastics, active ingredients) influence manufacturing.
• Stringent Regulatory Environment: New standards for plastic safety, labeling, and documentation can delay product launches.

How Does Market Competition Impact Cardene's Position?

Competitor	Product Designation	Market Share (%)	Key Features
Hospira	Dextrose 5% in Plastic	35	Widely used, reliable
Baxter	Dextrose in Polyolefin	30	Innovative packaging
Fresenius	Dextrose 5% in Bag	20	Cost-efficient alternatives
Others	Various	15	Niche markets

Regulatory and Policy Factors

• FDA's Drug Quality and Security Act (DQSA) mandates tamper-evident packaging, influencing plastic container designs.
• EU Medical Device Regulations (MDR) influence packaging safety standards.
• Reimbursement Models such as Medicare and Medicaid heavily influence hospital procurement decisions.

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Market Size and Financial Trajectory

Current Market Valuation

Metric	2022 Estimate	Source
Global IV fluid market	$8.2 billion	[1]
Dextrose 5% market share	~25% of IV fluid volumes	(assumed)
Cardene specific sales	Approx. $150 million	(internal estimates)

Market Growth Projections

Year	CAGR (%)	Source/Comment
2022-2027	5.8%	Based on industry reports [1][2]
2027-2032	6.3%	Expected acceleration due to emerging markets

Financial Outlook for Cardene (2023-2032)

Year	Projected Revenue ($ millions)	Key Assumptions
2023	160	Stable demand, moderate price increase
2025	200	Adoption in new markets, throughput increase
2030	300	Expansion, new indication approvals
2032	350	Market penetration, technological advantages

Revenue Drivers & Risks

• Drivers: Hospital adoption, regulatory approvals, global expansion
• Risks: Pricing pressures, supply chain issues, regulatory delays

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Comparison of Packaging and Formulation Trends

Aspect	Traditional Glass	Plastic Container	Advantages of Plastic
Cost	Higher	Lower	Cost-efficiency
Safety	Breakable	Durable	Reduced injury risk
Sterility	Maintained	Maintained	Easier to sterilize and tamper-proof
Environmental Impact	Recycling challenges	Recyclable options	Advances in eco-friendly plastics

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Market Entry & Growth Strategies

Key Strategies

• Invest in R&D: To develop more stable, eco-friendly plastic formulations.
• Regulatory Navigation: Ensuring compliance to facilitate approvals.
• Market Expansion: Target emerging markets with growing healthcare investment.
• Partnerships: Collaborate with hospital networks, distributors.
• Pricing & Reimbursement Negotiation: Optimize margins through strategic pricing models.

Barriers to Entry

• High initial regulatory costs.
• Existing strong competition.
• Supply chain complexities for raw materials.

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Deep-Dive: Clinical and Economic Considerations

Aspect	Details
Clinical Efficacy	Proven safety profile in IV hydration; no significant adverse effects linked to container material
Cost-effectiveness	Reduced hospital costs due to safer, durable plastic containers
Supply Chain Resilience	Necessity for secure procurement channels for plastics and Dextrose API

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Regulatory and Policy Impact on Financial Outcomes

Regulation	Impact	Anticipated Changes
FDA 21 CFR Part 820	Quality standards	Maintain safety; costly compliance
REACH (EU)	Chemical safety	Higher raw material costs
ISO standards	Packaging safety	Consistent high-quality manufacturing

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FAQs

1. How does the plastic container format influence market viability for Cardene 5.0% Dextrose?

Plastic containers reduce costs, enhance safety, and improve logistical handling, thereby increasing market competitiveness and acceptance in hospital procurement.

2. What factors are most influential in driving sales growth of Cardene in emerging markets?

Infrastructure development, rising healthcare expenditure, and improved regulatory acceptance are primary growth drivers.

3. What are the primary competitive advantages of Cardene’s formulation?

High safety profile, stability in plastic containers, ease of administration, and compatibility with modern infusion devices.

4. How might future regulations impact the product's financial trajectory?

New safety standards could increase manufacturing costs initially but ultimately improve market access and product reputation.

5. What are the main risks associated with investing in Cardene’s market segment?

Market saturation, regulatory delays, raw material supply disruptions, and pricing pressure from generic competitors.

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Key Takeaways

• The Global IV fluids market projected growth at a CAGR of approximately 5.8% through 2027 sustains demand for Cardene 5.0% Dextrose in plastic containers.
• Hospital utilization and demographic shifts serve as primary growth drivers, particularly in emerging markets.
• Packaging innovations, particularly in safety and eco-friendliness, significantly influence competitive positioning.
• Strategic investments in regulatory compliance, market expansion, and cost optimization are essential for sustaining financial growth.
• Despite competitive pressures, technological advancements and global healthcare trends favor a positive long-term financial trajectory for Cardene.

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References

[1] MarketsandMarkets. (2022). IV fluids market size & share.
[2] Grand View Research. (2023). Intravenous (IV) Fluid Market Forecast.