CARDENE Drug Patent Profile

When do Cardene patents expire, and when can generic versions of Cardene launch?

Cardene is a drug marketed by Chiesi and is included in three NDAs. There are six patents protecting this drug.

The generic ingredient in CARDENE 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

A generic version of CARDENE was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for CARDENE

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	154
Clinical Trials:	9
Patent Applications:	4,162
Drug Prices:	Drug price information for CARDENE
What excipients (inactive ingredients) are in CARDENE?	CARDENE excipients list
DailyMed Link:	CARDENE at DailyMed

See drug prices for CARDENE

Recent Clinical Trials for CARDENE

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 clinical trials

Pharmacology for CARDENE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988		DISCN	Yes	No
Chiesi	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-002	Jul 31, 2008		RX	Yes	Yes
Chiesi	CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	019734-005	Nov 7, 2008		DISCN	Yes	No			Y

Expired US Patents for CARDENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE	nicardipine hydrochloride	CAPSULE;ORAL	019488-001	Dec 21, 1988
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992
Chiesi	CARDENE	nicardipine hydrochloride	INJECTABLE;INJECTION	019734-001	Jan 30, 1992

International Patents for CARDENE

See the table below for patents covering CARDENE around the world.

Country	Patent Number	Title	Estimated Expiration
France	2218107
Austria	63810
Finland	58772
China	101484006	Pre-mixed, ready-to-use iv bolus compositions and methods of use

Market Dynamics and Financial Trajectory for CARDENE

Last updated: December 27, 2025

Executive Summary

CARDENE (nicardipine hydrochloride) is a calcium channel blocker indicated primarily for acute hypertension and angina. Its market landscape is shaped by evolving cardiovascular treatment protocols, regulatory policies, and competitive dynamics within the pharmacological space. This analysis provides a comprehensive overview of CARDENE’s current positioning, forecasted growth, competitive environment, regulatory factors, and key economic indicators that influence its financial trajectory. The report synthesizes recent data up to 2023, offering strategic insights for investors, pharmaceutical companies, and healthcare stakeholders.

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What is the Market Position of CARDENE?

Overview

• Therapeutic Class: Calcium channel blocker (antihypertensive)
• Indications: Hypertension—specifically in hypertensive emergencies, and angina
• Formulation: IV and oral, with intravenous form historically predominant in acute care settings
• Manufacturers: Originally developed by Pfizer, now marketed by Chiesi Global Respiratory and other regional players

Current Market Share

Parameter	Data / Trend (2023)
Global sales (est.)	~$250 million (2022)
Market share (hospital segment)	~5–7% among IV antihypertensives
Major regional markets	U.S., Europe, Japan
Key competitors	Clevidipine (Cleviprex), labetalol, enalapril

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What Are the Market Drivers and Barriers?

Drivers

1. Rising Prevalence of Cardiovascular Diseases:
   According to WHO, over 530 million people suffer from hypertension globally, supporting increased demand for effective antihypertensive agents [1].

2. Hospitalization Trends for Hypertensive Emergencies:
   Hypertensive crises require swift, reliable interventions, favoring IV agents like CARDENE.

3. Advancements in Critical Care Protocols:
   Updated guidelines from American Heart Association and European Society of Cardiology endorse calcium channel blockers for specific indications, stabilizing demand [2].

4. Aging Populations:
   Elderly demographics are highly susceptible to hypertension, expanding the patient base.

Barriers

1. Generic Competition:
   Patent expiries have led to increased availability of cheaper alternatives such as labetalol and clevidipine.

2. Pricing Pressures and Reimbursement Changes:
   Governmental price negotiations and restrictive formularies reduce profit margins.

3. Limited Oral Formulation Preference:
   Predominant use in acute settings constrains broader outpatient market potential.

4. Regulatory and Safety Concerns:
   Reports of adverse effects, including hypotension, challenge clinical acceptance.

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How Does the Competitive Landscape Shape Market Dynamics?

Key Competitors and Market Shares

Drug	Formulation	Indicated Uses	Approximate Market Share (2023)	Notes
CARDENE (Nicardipine)	IV, oral	Hypertensive emergencies, angina	5–7%	Historically preferred in emergencies
Clevidipine (Cleviprex)	IV	Hypertensive crises in ICU	10–12%	Market expansion efforts, patent status
Labetalol	IV, oral	Hypertensive emergencies, pre-eclampsia	15–20%	Widely used, generic availability
Enalapril	Oral	Chronic hypertension, heart failure	10–15%	Mainly outpatient; limited IV role

Market Share Dynamics

• Brand vs. Generic:
  Post patent expiry, generic versions of CARDENE and competitors have gained share, pressuring prices.

• Specialty Segment Focus:
  The acute care setting remains a niche with steady demand, but outpatient and chronic therapy markets are minimal.

• Emerging Markets:
  Increasing adoption in Asia-Pacific and Latin America driven by rising hypertension prevalence.

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What are the Regulatory Policies Impacting CARDENE?

Regulatory Status

• FDA (U.S.):
  Approved in 1984; no recent substantial regulatory changes.
• EMA (Europe):
  Approved; usage governed by hospital protocols.
• Global Variations:
  Some emerging markets have approved generic versions with local approvals.

Impact of Policies

• Pricing Regulations:
  Countries like the UK and parts of Europe implement price caps for hospital medicines, affecting revenue.
• Approval Pathways:
  Bioequivalence studies for generics have accelerated market penetration, diluting branded sales.
• Reimbursement Policies:
  CBAs and hospital budgets directly influence adoption rates.

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What Financial Trajectory is Expected for CARDENE?

Revenue Forecast (2023–2028)

Year	Estimated Global Sales (USD Million)	CAGR (Compounded Annual Growth Rate)	Assumptions
2023	~$250	-	Market stabilizes; generic competition intensifies
2024	~$245	-2%	Slight decline due to pricing pressures
2025	~$260	+6%	Innovations, new formulations, regional growth
2026	~$275	+6%	Rising adoption in emerging markets
2027	~$295	+7%	Competitive strategies, potential new indications
2028	~$310	+5%	Mature market, stabilization

Market Segment Contributions

Segment	Share (%) (2023)	Notes
Acute hospital use	70%	Main revenue driver
Outpatient/chronic use	10%	Limited due to formulation constraints
Emerging markets	20%	Rapid growth potential

Key Financial Indicators

• Pricing Trends:
  Average wholesale price (~$15–$20 per dose in the U.S.) facing downward pressure due to generics.
• Cost of Goods Sold (COGS):
  Estimated at 35–40% of sales, influenced by manufacturing efficiencies.
• Profit Margins:
  Branded cardiopulmonary drugs typically enjoy 30–40% gross margins, which compress with generics.

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How do Pricing and Reimbursement Policies Affect Future Revenue?

Policy Aspect	Impact on CARDENE	Trends for 2023–2028
Price caps and negotiated discounts	Reduce revenue per unit	Tighter in developed nations
Reimbursement policies	Favor generics, limit premium prices	Growing emphasis on cost savings
Hospital formulary selections	Favor established, cost-effective agents	Competitive differentiation strategies

What Opportunities Exist for Market Expansion?

• Development of Novel Formulations:
  Liquid ready-to-use and sustained-release tablets could broaden use cases.
• Expansion into New Geographies:
  Targeting Asia-Pacific and Latin America with tailored pricing could increase sales.
• Partnerships and Licensing:
  Collaborations with local firms to facilitate market entry.

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What Are the Risks and Challenges?

Risks	Details
Patent expiries	Accelerate generic competition
Regulatory hurdles	Approval delays for new formulations or indications
Market saturation	Limited scope for Volume growth in mature markets
Pricing pressures	Governments and hospitals seeking lower-cost alternatives
Safety concerns	Adverse effects influencing clinician preferences

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Key Takeaways

• Market Dynamics:
  The cardiology medication landscape is increasingly competitive, with CARDENE positioned firmly in acute hospital settings but facing intense generic pressure.

• Growth Opportunities:
  Expansion into emerging markets, development of innovative formulations, and strategic partnerships represent potential revenue growth paths.

• Challenges:
  Price competition, regulatory constraints, and evolving clinical guidelines may constrain profitability.

• Financial Outlook:
  Moderate CAGR projections (~3–6%) suggest a stable but competitive future, with revenue streams largely driven by established institutional use and regional growth.

• Strategic Imperatives:
  Companies should innovate, optimize pricing strategies, and explore untapped markets to sustain and grow CARDENE’s market share.

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FAQ

1. What are the primary indications for CARDENE?
CARDENE is mainly indicated for hypertensive emergencies in acute care settings and angina, administered via IV to rapidly control blood pressure.

2. How does CARDENE compare to its competitors?
It is a preferred agent in ICUs due to its rapid onset and titratability but faces stiff competition from drugs like clevidipine and labetalol, especially post-patent expiry.

3. What are the key factors influencing CARDENE’s market growth?
Prevalence of hypertension, hospital adoption rates, competitive pricing, regulatory policies, and regional healthcare infrastructure.

4. Are there any recent regulatory developments impacting CARDENE?
No recent major regulations; however, increased use of generics and cost-control measures are impacting revenues.

5. What is the potential of CARDENE in emerging markets?
Growing healthcare infrastructure and rising hypertension prevalence make emerging markets promising, with potential for significant volume growth.

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References

1. WHO. (2022). Hypertension Data. https://www.who.int
2. American Heart Association. (2021). Hypertensive Crisis: Guidelines and Management Recommendations. https://www.heart.org
3. Chiesi Global Respiratory. (2023). CARDENE Product Profile.
4. MarketWatch. (2022). Healthcare Market Reports.
5. European Society of Cardiology. (2022). Hypertension Guidelines.

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This report offers an in-depth, data-driven perspective to inform strategic investment, R&D, and market expansion decisions concerning CARDENE and its associated therapy landscape.