CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile

When do Cardene In 0.86% Sodium Chloride In Plastic Container patents expire, and what generic alternatives are available?

Cardene In 0.86% 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 0.86% SODIUM CHLORIDE 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 0.86% Sodium Chloride In Plastic Container

A generic version of CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE IN 0.86% 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
DailyMed Link:	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CARDENE IN 0.86% 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 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for CARDENE IN 0.86% 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 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

CARDENE IN 0.86% 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 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	7,659,291
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	9,364,564		Y
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	8,455,524
Chiesi	CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-003	Jul 31, 2008	AP	RX	Yes	Yes	11,547,758

International Patents for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Belgium	811324
Canada	2650922
Japan	S5720950
Mexico	9203588	INYECCION DE HIDROCLORURO DE NICARDIPINA.

Market Dynamics and Financial Trajectory for Cardene in 0.86% Sodium Chloride in Plastic Container

Last updated: July 29, 2025

---

Introduction

The pharmaceutical landscape for cardiovascular medications continues to evolve, driven by technological advancements, regulatory changes, and shifting patient demographics. Cardene (nicardipine hydrochloride), a calcium channel blocker primarily used to manage hypertension and angina, stands as a pivotal choice in inpatient and outpatient settings. The recent formulation of Cardene in a 0.86% sodium chloride solution housed in plastic containers reflects strategic formulation and packaging enhancements addressing safety, stability, and logistical efficiencies. This article evaluates the market dynamics and projects the financial trajectory for this formulation, considering current industry trends and external influences.

---

Market Overview

The global antihypertensive drugs market remains robust, projected to reach approximately USD 35 billion by 2027, fueled by rising prevalence of hypertension, aging populations, and increased awareness of cardiovascular health [1]. Within this market, calcium channel blockers (CCBs) constitute a significant segment, valued for their efficacy and safety profile.

Cardene's position in the intravenous (IV) antihypertensive space is reinforced by its quick onset and controllable dosage, especially in acute care facilities. The transition to a formulation in a 0.86% sodium chloride solution aligns with industry standards for isotonic solutions, ensuring patient safety and compatibility with existing IV systems. The move to a plastic container reflects evolving packaging paradigms favoring lightweight, shatter-resistant, and cost-effective materials, increasingly preferred over glass alternatives.

---

Market Drivers

1. Growing Hypertension Incidence

The global burden of hypertension affects over 1.3 billion people, driving increased use of antihypertensive agents like Cardene [2]. Acute hypertension management in hospitals and intensive care units (ICUs) is vital, with IV formulations like Cardene playing a crucial role.

2. Advancements in IV Drug Delivery

The shift toward safer, more convenient IV delivery systems bolsters demand. Plastic containers are favored for their durability and reduced risk of breakage, especially in high-pressure environments.

3. Regulatory and Safety Trends

Regulatory agencies emphasize compatibility and patient safety. The use of isotonic sodium chloride solutions in plastic containers minimizes infusion-related complications, aligns with USP standards, and facilitates rapid adoption.

4. Manufacturing & Cost Efficiency

Plastic container production is generally less costly and environmentally more sustainable than glass. Their lightweight nature reduces transportation costs, enabling broader distribution especially in emerging markets.

5. Market Expansion & Emerging Markets

Emerging economies exhibit rising hypertension rates and expanding healthcare infrastructure, creating additional avenues for Cardene’s distribution in new territories.

---

Competitive Landscape

Major competitors include other calcium channel blockers and antihypertensive IV formulations such as nifedipine, clevidipine, and nicardipine capsules or vials. The strategic move to a plastic container and the standardized 0.86% sodium chloride solution enhances Cardene’s market appeal through:

• Improved safety and compatibility.
• Greater logistical efficiencies.
• Enhanced shelf stability.

Patents, regulatory approvals, and clinical efficacy data further fortify its market positioning.

---

Regulatory Environment

FDA and EMA guidelines emphasize the stability, safety, and proper packaging of IV drugs. The adoption of plastic containers aligned with these standards ensures continued compliance, enabling broad commercialization and export initiatives. Regulatory approval processes are streamlined by demonstrating equivalent or superior safety profiles and stability in the new packaging.

---

Financial Trajectory

Revenue Projections

The revenue potential for Cardene in this formulation hinges on multiple factors:

• Market Penetration Rate: Estimated at 15–20% in NICU and ICU settings within the first three years post-launch [3].
• Pricing Strategy: Positioned as a premium yet cost-effective alternative; competitive with existing formulations.
• Pricing Dynamics: Anticipated unit price varies between USD 10–20 per 100 mL dose, depending on regional market, insurance coverage, and hospital procurement policies.

Assuming a conservative uptake, revenues could reach USD 200–300 million globally within five years, driven by existing formularies and hospital adoption. Growth is further supported by expanding markets in Asia-Pacific and Latin America.

Cost Structure & Profit Margins

Manufacturing costs for plastic containers are approximately 15–20% lower than glass counterparts, potentially increasing profit margins. Estimated gross margins for this formulation range between 40–50%, influenced by raw material costs and distribution expenses.

Regulatory & Patent Influence

Patent rights and exclusivity periods will significantly influence competitive dynamics and revenue longevity. Expiry dates, typically 7–12 years post-approval, need to be monitored to anticipate generic competition or biosimilar emergence.

---

Market Risks & Challenges

• Regulatory Delays: Unexpected approval hurdles or safety concerns could impede commercialization.
• Competition from Biosimilars: Entry of alternative agents or generics could erode market share.
• Pricing Pressures: Healthcare reimbursement policies and cost containment initiatives could limit profit margins.
• Supply Chain Disruptions: Material shortages in plastics or sodium chloride solutions may impact production.

---

Emerging Trends & Future Outlook

The trend toward personalized medicine and advanced drug delivery systems suggests potential for Cardene’s future formulations—such as targeted infusion devices or novel delivery mechanisms. Furthermore, the increasing focus on environmental sustainability favors biodegradable plastic containers, which could become a differentiator.

Biopharmaceutical collaborations and licensing agreements could also expand Cardene’s reach, especially in emerging markets. Mergers and acquisitions among generic manufacturers suggest a competitive but consolidating landscape, offering strategic opportunities for market expansion and financial scaling.

---

Key Takeaways

• The transition of Cardene to a 0.86% sodium chloride solution in plastic containers aligns with safety, logistical, and economic advantages, positioning it favorably in a competitive market.
• Rising hypertension prevalence and increasing hospital utilization underscore robust demand, with expected revenue growth accelerating over the next five years.
• Strategic manufacturing, regulatory compliance, and market expansion, especially into emerging regions, will be vital to maximizing financial success.
• Competitive pressures and regulatory shifts necessitate ongoing innovation, patent protection, and cost management to sustain profitability.
• Sustainability and personalized delivery offer future avenues for product differentiation and market leadership.

---

FAQs

1. What are the primary benefits of using plastic containers for Cardene’s IV formulation?
Plastic containers are lightweight, shatter-resistant, reduce transportation costs, and improve safety—especially important in busy clinical settings. They also allow for easier disposal and can be produced more sustainably than glass.

2. How does the 0.86% sodium chloride solution enhance Cardene’s safety profile?
This isotonic solution minimizes infusion site irritation and cellular edema risks, ensuring compatibility with human physiology. It maintains drug stability and ensures proper dilution, enhancing patient safety.

3. What factors will influence the market adoption of Cardene in new regions?
Regulatory approval timelines, hospital formulary inclusion, competitive landscape, pricing strategies, and local healthcare infrastructure are pivotal factors influencing adoption.

4. How will patent deadlines impact Cardene’s financial trajectory?
Patent expirations could open the pathway for generics, reducing prices and market share. Strategic patent extensions and lifecycle management are crucial to maintaining profitability.

5. What role will emerging markets play in the future growth of Cardene?
Emerging markets present significant growth opportunities due to increasing hypertension prevalence, expanding healthcare infrastructure, and demand for cost-effective IV drugs. Tailored strategies will be essential for successful penetration.

---

References

[1] MarketsandMarkets. (2022). Antihypertensive Drugs Market by Drug Class.
[2] World Health Organization. (2021). Hypertension Fact Sheet.
[3] Pharmaceutical Market Intelligence. (2023). Hospital and ICU Drug Utilization Trends.