NICARDIPINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for nicardipine hydrochloride and what is the scope of patent protection?

Nicardipine hydrochloride is the generic ingredient in ten branded drugs marketed by Chiesi, Amneal, Anda Repository, Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Navinta Llc, Pharmobedient, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma, Hikma Intl Pharms, Mankind Pharma, Micro Labs, Nanjing King Friend, Qilu Pharm Hainan, Rk Pharma, Sun Pharm, Inforlife, Caplin, and Cipla, and is included in twenty-nine NDAs. There are six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nicardipine hydrochloride has twenty-one patent family members in ten countries.

There are eleven drug master file entries for nicardipine hydrochloride. Twenty-six suppliers are listed for this compound.

Summary for NICARDIPINE HYDROCHLORIDE

International Patents:	21
US Patents:	6
Tradenames:	10
Applicants:	23
NDAs:	29
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	26
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	56
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NICARDIPINE HYDROCHLORIDE
What excipients (inactive ingredients) are in NICARDIPINE HYDROCHLORIDE?	NICARDIPINE HYDROCHLORIDE excipients list
DailyMed Link:	NICARDIPINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE

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

Sponsor	Phase
VZW Cardiovascular Research Center Aalst	PHASE4
Yuzuncu Yl University	NA
Boston Medical Center	Phase 4

See all NICARDIPINE HYDROCHLORIDE clinical trials

Pharmacology for NICARDIPINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for NICARDIPINE HYDROCHLORIDE

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for NICARDIPINE HYDROCHLORIDE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for NICARDIPINE HYDROCHLORIDE

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 NICARDIPINE HYDROCHLORIDE

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	10,758,616		Y
Amneal	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218202-001	Apr 10, 2024	AB	RX	No	No
Navinta Llc	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	CAPSULE;ORAL	218638-002	Jun 25, 2025	AB	RX	No	No
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 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes	9,364,564		Y
Micro Labs	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	INJECTABLE;INJECTION	216420-001	Jul 7, 2023	AP	RX	No	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992		DISCN	Yes	No

Expired US Patents for NICARDIPINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	3,985,758
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	4,880,823
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	5,198,226
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992	5,164,405

International Patents for NICARDIPINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2650922	COMPOSITIONS PHARMACEUTIQUES PREMELANGEES PRETES A L'EMPLOI (PRE-MIXED, READY-TO-USE PHARMACEUTICAL COMPOSITIONS)
New Zealand	572226	Pre-mixed, ready-to-use IV bolus compositions comprising nicardipine and methods of use
China	101484006	Pre-mixed, ready-to-use iv bolus compositions and methods of use
Australia	2007240820	Pre-mixed, ready-to-use pharmaceutical compositions
Mexico	2008013407	COMPOSICIONES DE BOLO IV PREMEZCLADAS, LISTAS PARA USO Y METODOS DE USO. (PRE-MIXED, READY-TO-USE IV BOLUS COMPOSITIONS AND METHODS OF USE.)
Brazil	PI0709617	composição farmacêutica, e, métodos para tratar elevações agudas de pressão sangüìnea em um indivìduo humano, para induzir a hipotensão em um indivìduo humano, e para produzir uma composição farmacêutica para administração intravenosa
China	101484006	Pre-mixed, ready-to-use iv bolus compositions and methods of use

Market dynamics and financial trajectory for the pharmaceutical drug: Nicardipine Hydrochloride

Last updated: July 27, 2025

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Introduction

Nicardipine hydrochloride, a calcium channel blocker primarily prescribed for managing hypertension and ischemic stroke, has experienced dynamic shifts in its market landscape. As a vital component in cardiovascular therapy, understanding its market dynamics and financial trajectories is crucial for pharmaceutical stakeholders, including manufacturers, investors, and healthcare policymakers. This analysis examines current market drivers, competitive positioning, regulatory influences, manufacturing considerations, and future growth potential of nicardipine hydrochloride.

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Market Overview

Nicardipine hydrochloride belongs to the dihydropyridine class of calcium channel blockers. Its widespread use in acute hypertensive emergencies and perioperative management has cemented its clinical importance. The global demand for antihypertensive treatments, especially in aging populations, sustains steady market consumption for nicardipine. The expanding prevalence of cardiovascular diseases (CVDs) globally further bolsters its market position [1].

Market Segmentation

The therapeutic market for nicardipine predominantly operates within hospital settings, selected outpatient care, and emergency medicine. The drug’s preference for intravenous administration in critical care contexts further confines its sales to specialized healthcare facilities. Geographically, North America and Europe represent mature markets with high penetration due to advanced healthcare infrastructure, while Asia-Pacific exhibits rapid growth driven by increasing CVD incidence and healthcare expenditure.

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Market Drivers

1. Rising Prevalence of Cardiovascular Diseases
   The World Health Organization reports a steady increase in hypertension worldwide, with over 1.3 billion adults affected. This escalation directly contributes to higher prescriptions for antihypertensive agents, including nicardipine [2].

2. Hospital-based Application and Acute Care Needs
   The intravenous formulation’s efficacy in acute hypertensive crisis and stroke management secures its demand within hospital settings. As healthcare systems emphasize prompt intervention, utilization rates remain robust [3].

3. Regulatory Endorsements and Clinical Guidelines
   Guidelines from the American Heart Association (AHA) and European Society of Cardiology (ESC) endorse calcium channel blockers for specific hypertensive conditions, reinforcing prescriptive practices [4].

4. Pipeline Developments and Formulation Innovation
   While the current formulations dominate, ongoing research into long-acting or oral variants could alter future market dynamics, broadening usage beyond acute settings.

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Competitive Landscape

The market for nicardipine hydrochloride features incumbents like Novartis, Sibeco, and Lannett, with generic manufacturers progressively increasing market share due to patent expirations. Patent cliffs, notably for branded versions, have prompted a surge in generic formulations, leading to price erosion and improved accessibility. This commoditization intensifies price competition but intensifies opportunities for cost-effective supply chains.

Patent and Regulatory Trends

Patent expirations globally, notably in the United States and Europe, have facilitated generic entry, pressing down pricing and expanding access. Meanwhile, regulatory bodies like the FDA and EMA continue to rigorously oversee manufacturing standards, impacting supply chains and compliance costs.

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Manufacturing and Supply Chain Considerations

Manufacturing nicardipine hydrochloride involves complex chemical synthesis with high purity requirements. Supply chain disruptions, such as raw material shortages or geopolitical tensions, threaten consistent production. The shift toward regional manufacturing hubs aims to mitigate risks, aligning with global health strategies and cost considerations.

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Financial Trajectory and Market Forecast

Pricing Trends and Revenue Projections

The commoditization trend results in declining per-unit prices for generic nicardipine hydrochloride. Nevertheless, the overall market value maintains stability due to rising demand driven by CVD prevalence. Market analysts project a compound annual growth rate (CAGR) of approximately 3-5% for the global nicardipine segment over the next five years, balancing volume increases against price compression [5].

Revenue Strategies and Market Penetration

Manufacturers are increasingly focusing on expanding distribution channels, optimizing formulation options, and entering emerging markets to sustain growth. Strategic alliances with healthcare institutions also enhance market presence.

Impact of Patent Expiry and Regulatory Changes

Patent expirations act as catalysts for generic proliferation, reducing prices and expanding patient access, which sustains market size but compresses profit margins. Conversely, favorable regulatory environments accelerating approval processes can catalyze market entry and foster competition.

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Future Outlook

The future trajectory of nicardipine hydrochloride hinges on multiple factors:

• Expansion into New Therapeutic Uses: Investigating applications in other hypertensive or vasospastic conditions may open additional revenue streams.
• Development of Sustained-Release Formulations: Innovations that prolong drug action could shift usage patterns from intravenous to oral, broadening the patient base.
• Emerging Market Penetration: Rapid urbanization and rising healthcare infrastructure in Asia-Pacific promise significant growth opportunities.
• Regulatory Landscape: Stringent approval processes could impede or accelerate market entry for new formulations or competitors.

The potential emergence of biosimilars or novel calcium channel blockers with superior efficacy could influence the market share dynamics of nicardipine.

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Regulatory and Legal Outlook

Compliance with evolving regulatory standards remains critical. Patent litigations, quality assurance mandates, and approval timelines considerably influence market entry and revenue realization strategies. Patent disputes might occasionally induce market hesitancy but also open avenues for generic manufacturers.

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Conclusion

Nicardipine hydrochloride's market is characterized by steady demand driven by the global rise in cardiovascular disease management, favorable regulatory endorsements, and ongoing product innovation. While patent expirations and generic competition exert downward pressure on prices, the expanding global hypertensive population sustains its market presence. Strategic shifts toward formulation innovations, geographic expansion, and adherence to regulatory standards will dictate its financial trajectory.

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Key Takeaways

• The global burden of hypertension and ischemic stroke sustains consistent demand for nicardipine hydrochloride.
• Patent expiries and generic competition have driven prices downward but expanded access.
• Regional growth, particularly in Asia-Pacific, offers substantial future revenue potential.
• Innovations in formulation and new therapeutic indications could diversify revenue streams.
• Regulatory compliance and supply chain resilience are pivotal for maintaining market stability.

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FAQs

1. What are the primary therapeutic indications for nicardipine hydrochloride?
Nicardipine hydrochloride is primarily indicated for acute hypertensive episodes, hypertensive emergencies, and perioperative management of blood pressure, especially in ischemic stroke settings requiring rapid blood pressure control.

2. How does patent expiration impact the market for nicardipine hydrochloride?
Patent expiration facilitates generic entry, decreasing prices and increasing accessibility. While this reduces brand-market share and profit margins, it expands total market volume and broadens patient access worldwide.

3. What are the main challenges facing the manufacturing of nicardipine hydrochloride?
Challenges include complex synthesis processes requiring high purity, raw material shortages, regulatory quality standards, and supply chain disruptions due to geopolitical or economic factors.

4. Which regions are expected to drive future growth for nicardipine hydrochloride?
The Asia-Pacific region is poised for significant growth, owing to expanding healthcare infrastructure and rising CVD prevalence. Developed markets like North America and Europe will sustain demand due to existing clinical practice patterns.

5. What future innovations could influence the market trajectory of nicardipine hydrochloride?
Development of sustained-release formulations, alternative administration routes, new therapeutic indications, and biosimilars are key innovations to watch, potentially transforming its usage landscape.

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References

[1] World Health Organization. Hypertension. WHO Fact Sheet. 2021.

[2] World Health Organization. Cardiovascular Diseases. Global status report. 2019.

[3] American Heart Association. Hypertension Management Guidelines. 2020.

[4] European Society of Cardiology. Guidelines on the management of hypertensive emergencies. 2018.

[5] Market Research Future. Global Nicardipine Market Analysis. 2022.

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