CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile

When do Cardene In 0.83% Sodium Chloride In Plastic Container patents expire, and when can generic versions of Cardene In 0.83% Sodium Chloride In Plastic Container launch?

Cardene In 0.83% Sodium Chloride 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 0.83% SODIUM CHLORIDE 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 0.83% Sodium Chloride In Plastic Container

A generic version of CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 0.83% SODIUM CHLORIDE 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
DailyMed Link:	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 0.83% SODIUM CHLORIDE 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 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 0.83% SODIUM CHLORIDE 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 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

CARDENE IN 0.83% SODIUM CHLORIDE 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 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	7,659,291
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	10,758,616		Y
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	11,547,758
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	8,455,524
Chiesi	CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-004	Nov 7, 2008	AP	RX	Yes	Yes	7,612,102		Y

International Patents for CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 0.83% SODIUM CHLORIDE 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

Market Dynamics and Financial Trajectory for CARDENE in 0.83% Sodium Chloride in Plastic Container

Last updated: July 28, 2025

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Introduction

CARDENE (nicardipine hydrochloride) in 0.83% sodium chloride in plastic container occupies a critical niche in antihypertensive therapy. As a calcium channel blocker, it provides targeted vascular smooth muscle relaxation, primarily for hypertensive emergencies and certain angina cases. This analysis examines the market forces shaping the drug’s commercial trajectory, evaluates the competitive landscape, and projects its financial outlook amid evolving healthcare dynamics.

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Market Overview

Global Pharmaceutical Landscape

The global antihypertensive drugs market has been expanding at a compound annual growth rate (CAGR) of approximately 3-5% over recent years, driven by increasing hypertension prevalence, aging populations, and drug innovation (1). Cardene, as a branded intravenous formulation, caters especially to acute care settings, serving hospitals, clinics, and emergency services.

Market Segmentation & Patient Demographics

The primary consumers of Cardene are hospital inpatient units, intensive care units (ICUs), and emergency departments. The drug’s utility in hypertensive crises, perioperative management, and vasospasm treatment underpins steady demand. The aging global population amplifies hypertensive patient populations, further bolstering market prospects.

Regulatory and Pricing Environment

Stringent regulatory requirements across major markets such as the U.S., EU, and Asia influence commercial strategies. Patents and exclusivity rights dictate initial market launch opportunities, while generic competition escalates post-expiry, impacting pricing and profitability (2).

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Market Drivers

1. Rising Hypertension Prevalence

The World Health Organization (WHO) estimates over 1.2 billion people worldwide suffer from hypertension, with projections indicating continued growth. The need for hospital-grade antihypertensive agents like Cardene remains robust in managing hypertensive crises, especially in settings requiring intravenous administration (3).

2. Hospital-Centric Drug Utilization

Hospitalizations for hypertensive emergencies are increasing, driven by comorbidities and lifestyle factors. Cardene’s formulation in a plastic container enhances convenience, safety, and compliance in controlled clinical environments.

3. Advancements in Drug Delivery & Formulation

The shift toward prefilled, ready-to-use plastic containers aligns with hospital operational efficiencies, reduces preparation errors, and minimizes contamination risks. Such innovations sustain Cardene’s relevance despite competition from alternative calcium channel blockers and newer therapeutic modalities.

4. Patent and Regulatory Exclusivity

Patent protection and regulatory exclusivity periods shield Cardene from direct competition, enabling premium pricing. However, patent cliffs approaching or materialized can introduce biosimilars or generics, pressing margins.

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Market Constraints & Challenges

1. Competition from Generics and Biosimilars

Post-patent expiration, the entry of generic nicardipine formulations significantly diminishes market share and pricing power. Market penetration of low-cost alternatives impacts revenue streams and challenges profit margins.

2. Emerging Oral Alternatives

Development of oral antihypertensive agents and long-acting formulations may reduce dependence on intravenous drugs for certain clinical scenarios, affecting inpatient demand.

3. Regulatory and Reimbursement Shifts

Changing reimbursement policies, especially in markets like the U.S. with cost-containment measures, exert pressure on hospital procurement decisions. Value-based purchasing models prioritize cost-effective therapies, influencing Cardene’s profitability.

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Financial Trajectory and Market Potential

1. Revenue Forecasting

In its peak patent phase, Cardene generated annual revenues estimated around USD 300-400 million globally (4). Anticipated generic entry could precipitate a decline of 40-60% over 3-5 years unless differentiated attributes or new indications emerge.

2. Growth Strategies

Pharmaceutical firms may pursue line extensions, such as novel formulations, or target niche markets like perioperative care, to sustain revenues. Additionally, exploring markets with emerging healthcare infrastructure, particularly in Asia, can unlock incremental growth.

3. Impact of Market Dynamics

The increasing incidence of hypertension supports underlying demand. However, profit margins hinge on effective lifecycle management, cost control, and diversification strategies. Investments in downstream pipeline drugs could buffer revenue erosion.

4. Pipeline and R&D Prospects

R&D efforts focusing on combination therapies or enhanced delivery systems could bolster Cardene’s positioning. Furthermore, potential for approval in new indications or dosage forms could revitalize its market trajectory.

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Competitive Landscape & Strategic Outlook

Major competitors include generic formulations of nicardipine, alternative intravenous antihypertensives like clevidipine, and emerging oral therapeutics. Strategic pricing, partnerships with healthcare providers, and digital health integrations form core tactics to sustain market share.

Pharmaceutical companies might explore mergers, acquisitions, or licensing deals to fortify their positions. Moreover, patent litigation and regulatory submissions for new formulations remain pivotal dynamics.

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Regulatory and Market Entry Risks

The drug’s future market success faces potential hurdles from regulatory modifications and shifts in hospital procurement policies favoring cost-effective generics. Additionally, global health crises, such as pandemics, could temporarily disrupt hospital drug procurement patterns, impacting Cardene’s sales.

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Conclusion & Strategic Recommendations

The financial trajectory of Cardene in 0.83% sodium chloride in plastic containers hinges on balancing patent exclusivity benefits against impending generic competition. While current market momentum supports steady demand driven by a rising hypertensive patient base and hospitalization rates, long-term growth depends on innovation, diversification, and strategic market expansion.

Healthcare providers’ increasing preference for cost-containment practices underscores the importance of demonstrating value propositions—through clinical efficacy, safety profiles, and operational efficiencies—in defending market share. Leveraging emerging markets’ healthcare infrastructure and expanding indications can serve as leverage points. Finally, active engagement in lifecycle management and R&D for new formulations will be critical to sustain profitability.

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Key Takeaways

• The global demand for intravenous antihypertensives like Cardene remains robust within hospital settings, driven by hypertensive emergencies.
• Patent expirations threaten revenue streams, necessitating strategic innovation, lifecycle management, and market diversification.
• Competitive pressures from generics and emerging oral therapies challenge pricing power, emphasizing the need for value differentiation.
• Expansion into emerging markets and exploration of new indications or formulations offer growth opportunities.
• Regulatory and reimbursement environments will significantly influence future market trajectories; proactive engagement is vital.

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FAQs

1. What factors influence Cardene’s market share in the hospital setting?
Market share hinges on patent protection, formulary positioning, hospital procurement policies, pricing strategies, and clinical efficacy compared to competitors.

2. How does patent expiry impact Cardene’s revenue?
Patent expiry enables generic manufacturers to produce lower-cost alternatives, exerting downward pressure on pricing and reducing Cardene’s market dominance.

3. Are there new formulations or indications for Cardene?
Current R&D efforts focus on improved delivery systems and potential new indications in perioperative or cerebrovascular applications, which could extend its market viability.

4. How significant is geographic market expansion for Cardene?
Emerging markets with expanding healthcare infrastructure present significant growth opportunities, especially where intravenous antihypertensives are in demand.

5. What strategic actions can pharmaceutical companies take to sustain Cardene’s profitability?
Companies should pursue lifecycle management, develop innovative formulations, expand indications, engage in strategic partnerships, and optimize supply chain efficiencies.

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References

1. MarketsandMarkets. (2022). Hypertension Drugs Market Growth Analysis.
2. FDA. (2021). Regulatory Guidelines for Intravenous Medications.
3. WHO. (2021). Hypertension Factsheet.
4. IMS Health Data. (2020). Global Cardene Sales and Market Share.