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-five 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
Vanderbilt University Medical Center	Phase 2
National Institute of Neurological Disorders and Stroke (NINDS)	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
European Patent Office	2012788	COMPOSITIONS EN BOLUS IV PRE-MELANGEES PRETES A L'EMPLOI ET PROCEDES D'UTILISATION (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE)
Japan	S49135976
Canada	2650922
New Zealand	572226
Spain	8700567
Japan	S5720950
World Intellectual Property Organization (WIPO)	2007123984

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

Last updated: July 29, 2025

Introduction

Cardene (nicardipine hydrochloride) is a well-established calcium channel blocker primarily prescribed for the management of hypertensive emergencies and certain types of angina. In its formulation combined with 5.0% dextrose in a plastic container, the drug addresses specific clinical needs within hospital settings. This combination—intravenous nicardipine with dextrose—targets acute care settings requiring rapid blood pressure control. Understanding the current market dynamics and projecting the financial trajectory of this formulation hinges on a comprehensive analysis of pharmacological trends, healthcare infrastructure, competitive landscape, regulatory pathways, and economic factors.

Market Overview

The intravenous (IV) nicardipine formulation with dextrose in a plastic container occupies a specialized niche within hospital formulary. It is predominantly used in intensive care units (ICUs) and emergency departments owing to its efficacy in hypertensive crises. This segment aligns with broader trends in acute care medicine emphasizing rapid, controlled intervention to stabilize critically ill patients.

The global intravenous antihypertensive market is estimated to grow steadily, driven by rising prevalence of hypertension, increasing incidences of hypertensive emergencies, and expanding ICU admissions. According to industry reports, the market size of intravenous calcium channel blockers, including nicardipine, is projected to reach multi-billion dollar levels over the next five years, with a compound annual growth rate (CAGR) between 4-6% [1].

Market Drivers

1. Rising Hypertension and Emergency Cases
   The global burden of hypertension affects over 1.3 billion adults, with a significant subset experiencing hypertensive emergencies requiring IV medications like nicardipine [2]. An aging population and lifestyle factors contribute to increasing demand.

2. Expanding ICU and Emergency Department Capacity
   Growing ICU admissions, coupled with a preference for rapid, hospital-based interventions, bolsters demand for IV formulations. NICARDIPINE’s quick onset makes it a favored choice.

3. Regulatory Approvals and Patent Expirations
   Existing formulations of Cardene are off-patent, allowing multiple manufacturers to produce generic versions. This enhances accessibility but also intensifies competition.

4. Healthcare Infrastructure and Adoption of Hospital-Use IV Drugs
   Emerging markets are investing in healthcare infrastructure, expanding access to advanced IV therapies.

Market Challenges

• Generic Competition: With patent expirations, numerous generic manufacturers can produce equivalent formulations, exerting downward pressure on prices and margins.
• Pricing Pressures and Reimbursement Policies: Payer systems in developed markets prioritize cost-effective therapies, limiting pricing flexibility.
• Formulation and Supply Chain Considerations: The stability of nicardipine in dextrose solution, compatibility with plastic containers, and sterility standards influence manufacturing costs and scalability.

Financial Trajectory

Given these factors, the financial outlook for Cardene 5.0% Dextrose in Plastic Containers indicates a cautious but steady growth pattern, contingent on several key variables:

Revenue Forecast

• Market Penetration: Established hospitals and ICU networks are the primary adopters, with slower uptake in emerging markets initially. Assuming a modest market share of 10-15% among generic intravenous antihypertensives, revenues are projected to increase aligned with the growth of acute care markets.
• Pricing Strategy: Due to commoditization, pricing pressures are expected to reduce unit margins. A projected annual decline in gross margins of 2-3% could occur unless differentiated by added value, such as improved stability or proprietary delivery systems.

Cost Considerations

• Manufacturing & Distribution: Leveraging scale, bulk manufacturing and efficient supply chains will be essential to maintaining profitability in a competitive landscape.
• Regulatory Compliance & Quality Control: Continuous investment in compliance ensures market access but slightly elevates costs.

Profitability Outlook

• Short-term (1-2 years): Profit margins may tighten owing to aggressive generic competition and pricing pressures.
• Mid to Long-term (3-5 years): Market consolidation, increased hospital adoption, and possible formulation innovations could stabilize revenues and expand margins marginally.

Investment and Growth Strategies

• Partnerships & Licensing Agreements: Collaborations with hospital chains and distribution networks can streamline market access.
• Formulation Innovation: Developing proprietary formulations or delivery mechanisms (e.g., pre-filled syringes) could create differentiation.
• Geographical Expansion: Focus on emerging markets with rising healthcare infrastructure is critical for revenue diversification.

Regulatory and Patent Landscape

Currently, the patent status of Cardene formulations varies by region, with many markets facing patent expirations. This landscape fosters generic proliferation but also exposes the brand to pricing erosion. Regulatory approval pathways for biosimilars or secondary formulations in jurisdictions such as the U.S. FDA, EMA, and other agencies influence rapid market entry and revenue realization.

Competitive Landscape

Key competitors comprise major generics manufacturers and branded alternatives like clevidipine, which are used in similar settings. The increasing commoditization of IV antihypertensives underscores the importance of cost leadership and supply chain efficiency.

Concluding Perspectives

The financial trajectory of Cardene in 5.0% Dextrose in Plastic Container is expected to mirror broader trends in hospital-based IV antihypertensives: steady growth with margin compression. Strategic differentiation, operational efficiencies, and geographic expansion are vital in maintaining profitability. The overarching market growth driven by hypertensive emergencies and critical care needs bodes well, but intense competition mandates continuous innovation and strategic positioning.

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Key Takeaways

• The intravenous Cardene formulation in 5.0% dextrose is positioned within a growing niche driven by hypertension prevalence and ICU demand.
• Market growth forecasts project a CAGR of 4-6%, but profits will face pressure due to widespread generic competition and pricing constraints.
• Strategic initiatives—such as formulation innovation, hospital partnerships, and geographic expansion—are essential for sustainable profitability.
• Regulatory dynamics and patent expirations will influence market access and competitive pressures.
• The formulation’s success hinges on operational efficiency, quality assurance, and maintaining cost leadership amid a commoditized environment.

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FAQs

1. What are the primary factors influencing the demand for Cardene in dextrose formulations?
Demand is driven by the prevalence of hypertensive emergencies requiring IV treatment, the adoption of Cardene in ICU and emergency care, and increasing healthcare infrastructure globally.

2. How does patent expiration impact the financial prospects of Cardene formulations?
Patent expirations open markets to generic manufacturers, increasing competition, reducing prices, and compressing profit margins, but also expanding market access.

3. What role do emerging markets play in the growth of IV antihypertensive drugs like Cardene?
Emerging markets offer growth opportunities through expanding healthcare infrastructure, increasing hospital admissions, and growing hypertension prevalence, though initial barriers include regulatory integration and price sensitivity.

4. What competitive advantages can pharmaceutical companies leverage to succeed in this market?
Differentiation through formulation innovation, cost-efficient manufacturing, robust supply chains, strategic partnerships, and expansion into untapped regions are crucial.

5. What are the key risks that could negatively affect the financial trajectory of Cardene in this formulation?
Risks include intense generic competition, regulatory hurdles, pricing pressures from insurers, supply chain disruptions, and slow adoption in new markets.

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Sources

1. MarketResearch.com, “Global Intravenous Antihypertensive Drugs Market,” 2022.
2. WHO, “Hypertension Fact Sheet,” 2021.