CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cardene In 4.8% Dextrose In Plastic Container, and when can generic versions of Cardene In 4.8% Dextrose In Plastic Container launch?

Cardene In 4.8% Dextrose In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Twenty-six 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 4.8% Dextrose In Plastic Container

A generic version of CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

International Patents:	21
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	9
DailyMed Link:	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

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

Sponsor	Phase
Boston Medical Center	Phase 4
University of Cincinnati	Phase 2
Vanderbilt University Medical Center	Phase 2

See all CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 4.8% 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

US Patents and Regulatory Information for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER is protected by six 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 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes			Y

International Patents for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8700567
Belgium	811324
Mexico	2008013405	COMPOSICIONES FARMACEUTICAS PREMEZCLADAS LISTAS PARA USO. (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS.)
United Kingdom	1455502
Germany	3582954
European Patent Office	2018152	COMPOSITIONS PHARMACEUTIQUES PRÉMÉLANGÉES PRÊTES À L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)

Market Dynamics and Financial Trajectory for CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

Last updated: July 27, 2025

Introduction

The pharmaceutical product Cardene (nicardipine hydrochloride) in a 4.8% dextrose solution housed in a plastic container is a specialized intravenous (IV) formulation primarily indicated for hypertensive crises and certain cardiac conditions. As part of the calcium channel blocker class, Cardene’s unique formulation in dextrose offers both clinical and logistical distinctions that influence its market dynamics and financial outlook.

This analysis explores the key drivers shaping market demand, competitive landscape, regulatory environment, pricing strategies, and future growth prospects, with an emphasis on the product's intrinsic features and external economic factors impacting its trajectory.

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Market Overview

Product Profile and Clinical Significance

Cardene’s IV formulation provides rapid, controlled antihypertensive effects, making it vital in acute care settings. Its 4.8% dextrose buffer enhances stability and compatibility with IV fluids, simplifying infusion procedures in hospitals. The plastic container improves portability, reduces breakage risk, and aligns with modern hospital supply chains.

Market Size and Segment

The global IV drugs market, valued at approximately USD 70 billion in 2022, is projected to grow at a CAGR of around 7% through 2027 [1]. Within this, the antihypertensive IV segment accounts for a significant share, driven by the prevalence of hypertension and cardiovascular diseases. Cardene’s niche in critical care, though specialized, benefits from the expanding hospital infrastructure and growth in acute care admissions worldwide.

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Market Dynamics

Drivers

• Rising Incidence of Hypertensive Emergencies: According to WHO data, hypertension affects over 1 billion people globally, with many experiencing hypertensive crises requiring IV intervention [2]. This elevates demand for efficacious antihypertensive drugs like Cardene.

• Expanding Critical Care Infrastructure: Increasing investments in healthcare facilities, particularly in emerging markets, expand access to IV therapies, boosting sales opportunities.

• Preference for Stable, Compatible IV Formulations: The shift toward pre-filled plastic containers streamlines hospital logistics and minimizes contamination risks, favoring products like Cardene in similar packaging.

• Regulatory Approvals and Guidelines: Endorsements from bodies like the American Heart Association enhance clinical acceptance, indirectly impacting demand.

Challenges

• Generic Competition: Once patent protections lapse, multiple generics enter the market, exerting downward pressure on prices and market share.

• Pricing and Reimbursement Policies: Budget constraints and strict reimbursement policies in key markets such as the US and Europe influence pricing strategies and volume sales.

• Supply Chain Disruptions: Global supply chain issues, especially for raw materials and packaging components, can impact production continuity and cost structures.

Opportunities

• Market Expansion in Emerging Economies: Increasing healthcare penetration and chronic disease prevalence open new markets.

• Development of New Formulations: Innovations that improve stability, dosing flexibility, or reduce administration time can differentiate Cardene products.

• Strategic Partnerships and Licensing: Collaborations with regional manufacturers can expand distribution channels and reduce entry barriers.

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Financial Trajectory

Revenue Projections

While specific sales figures for Cardene in 4.8% dextrose in plastic containers are proprietary, historical trends and market growth indicators suggest a moderate, yet sustained, revenue increase. An estimated compound annual growth rate (CAGR) of 4-6% over the next five years aligns with the broader IV antihypertensive segment, assuming successful market expansion and penetration.

Pricing Outlook

Pricing is sensitive to competition and healthcare reimbursements. Brand-name versions, though initially priced higher, face erosion with generic entries. Maintaining a premium position relies on demonstrated clinical benefits and packaging innovations, especially in developed markets.

Cost Considerations

Manufacturing costs are influenced by raw material prices, regulatory compliance, and packaging expenses (plastic container integration). Economies of scale and innovations in production processes may mitigate cost pressures.

Profitability Prospects

Unlocking higher margins hinges on capturing market share through strategic marketing, optimizing supply chain efficiencies, and differentiating through product quality and support services. Patent protections and regulatory exclusivities in key markets provide initial revenue buffers, but inevitable patent cliffs may challenge long-term profitability.

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Regulatory and Market Access Landscape

Regulatory Environment

Patents on the proprietary aspects of Cardene IV formulations, including unique packaging in plastic containers, provide exclusive market rights for a limited period. Post-patent, generic manufacturers can introduce similar products, intensifying price competition [3].

Regulatory agencies such as the FDA in the US and EMA in Europe require demonstration of quality, safety, and efficacy. The manufacturing of plastic container-based formulations must adhere to rigorous standards, influencing production costs and timelines.

Market Access and Reimbursement

Successful commercialization depends on securing reimbursement codes and favorable formulary placements. Hospitals and healthcare payers prefer cost-efficient options; thus, demonstrating therapeutic equivalence and value is critical for maintaining premium pricing.

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Future Growth Drivers

• Innovation in Drug Delivery: Focus on smart infusion systems and biodegradable containers could enhance product appeal.

• Population Demographics: Aging populations globally increase demand for cardiovascular interventions, bolstering the overall market.

• Healthcare Digitalization: Integration into hospital electronic health records and infusion monitoring systems offers opportunities for growth.

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Risks and Mitigation Strategies

• Patent Expirations: Patents offering exclusivity must be leveraged with lifecycle management strategies, including product line extensions and regional patent filings.

• Market Entry of Generics: Building brand recognition and emphasizing clinical benefits can sustain market share post-patent expiry.

• Regulatory Delays: Early engagement with regulatory bodies and robust clinical data procurement minimize approval risks.

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Key Takeaways

• The market for Cardene in 4.8% dextrose in plastic containers is primarily driven by the increasing prevalence of hypertensive crises and expanding critical care infrastructure globally.
• Innovation, strategic partnerships, and regulatory compliance are vital to capturing market share and enhancing profitability amid competitive pressures.
• The product’s future financial trajectory will depend on market expansion, patent protections, cost management, and the ability to adapt to evolving healthcare technologies.
• Pricing strategies must balance reimbursement realities and competitive positioning, especially as generics threaten exclusivity.
• Emerging markets and demographic shifts offer significant growth avenues, but require tailored regulatory and distribution strategies.

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FAQs

1. How does the plastic container format influence Cardene’s marketability?
The plastic container enhances portability, reduces breakage risk, and aligns with hospital logistics, facilitating faster adoption and greater acceptance in hospital settings, thereby expanding market reach.

2. What are the primary factors affecting Cardene’s pricing strategies?
Pricing is influenced by market competition, reimbursement policies, manufacturing costs, and the clinical value proposition. Patent exclusivity allows initial premium pricing, which may decline upon generics entry.

3. How do regulatory and patent protections impact the product’s financial outlook?
Regulatory approvals uphold product standards and market access but may impose costs and delays. Patent protections provide exclusivity, enabling higher margins, but their expiration introduces competitive pressures.

4. What growth opportunities exist in emerging markets for this formulation?
Increasing healthcare infrastructure, rising cardiovascular disease prevalence, and limited current product penetration make emerging markets attractive for expansion with localized marketing, partnerships, and tailored pricing.

5. What are the key risks to Cardene’s future sales, and how can they be mitigated?
Risks include patent expiration, generic competition, supply chain disruptions, and regulatory hurdles. Mitigation strategies involve lifecycle management, continuous innovation, robust supply chains, and compliance adherence.

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References

[1] MarketsandMarkets, "IV Drugs Market by Product," 2022.
[2] WHO, "Hypertension Fact Sheet," 2021.
[3] U.S. Food and Drug Administration, "Patent and Exclusivity," 2023.