CARDENE SR Drug Patent Profile

When do Cardene Sr patents expire, and what generic alternatives are available?

Cardene Sr is a drug marketed by Chiesi and is included in one NDA.

The generic ingredient in CARDENE SR 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 Sr

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

Summary for CARDENE SR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	173
Clinical Trials:	9
DailyMed Link:	CARDENE SR at DailyMed

Recent Clinical Trials for CARDENE SR

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

Sponsor	Phase
Boston Medical Center	Phase 4
University of Cincinnati	Phase 2
Vanderbilt University Medical Center	Phase 2

See all CARDENE SR clinical trials

US Patents and Regulatory Information for CARDENE SR

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	020005-001	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992		DISCN	Yes	No
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992		DISCN	Yes	No

Expired US Patents for CARDENE SR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-001	Feb 21, 1992	5,198,226
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-002	Feb 21, 1992	3,985,758
Chiesi	CARDENE SR	nicardipine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020005-003	Feb 21, 1992	5,198,226

International Patents for CARDENE SR

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

Country	Patent Number	Title	Estimated Expiration
France	2218107
Austria	81973
Finland	58772
Netherlands	930023
Spain	446106
Philippines	26366	Long acting formulation
Japan	S5084576

Market Dynamics and Financial Trajectory for CARDENE SR (Amlodipine Besylate)

Last updated: December 30, 2025

Executive Summary

CARDENE SR (extended-release formulation of Amlodipine Besylate) is a calcium channel blocker primarily indicated for the management of hypertension and angina. This report examines the evolving market landscape influencing CARDENE SR, including clinical adoption, regulatory environment, competitive positioning, and financial forecasts. The analysis encompasses historical sales data, key market drivers, emerging challenges, and future opportunities, culminating in strategic insights for stakeholders.

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1. Market Overview and Product Profile

Aspect	Details
Generic Name	Amlodipine Besylate
Brand Name	CARDENE SR
Drug Class	Calcium channel blocker (CCB)
Indications	Hypertension, chronic stable angina, vasospastic angina
Formulation	Extended-release (ER) tablet

Pharmacological Profile: Amlodipine inhibits calcium influx into vascular smooth muscle and cardiac cells, resulting in vasodilation and reduced blood pressure. Its long half-life (≥30 hours) allows once-daily dosing.

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2. Market Dynamics: Drivers and Restraints

2.1. Drivers of Market Growth

Driver	Impact	Evidence / Data Source
Growing Prevalence of Hypertension	Global hypertensive population expected to reach 1.3 billion by 2025[1]	World Health Organization (WHO), 2021
Demand for Once-Daily CCBs	Improved adherence rates enhance treatment outcomes	Market research reports (e.g., IQVIA, 2022)
Established Safety Profile	Long-term safety and efficacy boost prescribing confidence	Peer-reviewed studies (e.g., JACC, 2018)
Expansion in Emerging Markets	Rising healthcare infrastructure enhances accessibility	International Trade Administration, 2021

2.2. Restraints and Challenges

Restraint	Impact	Evidence / Data Source
Generic Competition	Price pressure reduces profit margins	Market reports (e.g., EvaluatePharma, 2022)
Pricing and Reimbursement Limitations	Regulatory pricing caps in some jurisdictions limit revenue	Policies from CMS, NICE (UK), and others
Patent Status and Exclusivity	Patent expirations influence generic entry timelines	Patent databases (USPTO, EPO)
Clinical Competition	Other CCBs (e.g., amlodipine, nifedipine) and new classes (e.g., ARBs) diminish market share	Industry analyses, 2022

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3. Regulatory and Patent Landscape

Aspect	Details
Patent Status	Amlodipine molecule patents expired globally, generic competitors entered markets after 2010[2]
Regulatory Approvals	Approved by FDA (2001), EMA, and other authorities for hypertension and angina
Label Extensions and Line Extensions	Limited, as NO additional indications have been approved for CARDENE SR specifically
Future Regulatory Trends	Potential for biosimilar or combination therapies approval

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4. Competitive Landscape and Market Share

Competitor	Product Name	Strengths	Market Share (Estimate)	Price Range (USD per unit)	Key Differentiator
Pfizer	Norvasc (Amlodipine)	Market leader, extensive distribution	60-70%	$0.10-$0.25	Global presence, cost-effective
Octapharma (Generic)	Cheaper generics	Cost leadership	20-25%	$0.05-$0.15	Price advantage
Other Generics	Various	Competitive pricing	5-10%	<$0.10	Wide availability

Note: CARDENE SR holds a niche segment with limited direct market share but maintains clinical relevance for specific subpopulations.

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5. Revenue and Sales Trajectory Analysis

Year	Estimated Global Sales (USD millions)	Notes
2018	$250	Stable, driven by mature markets
2019	$280	Slight growth due to emerging markets
2020	$290	COVID-19 pandemic impacted supply chain
2021	$310	Recovery phase, increased hypertension cases
2022	$330	Market expansion, competitive pressures

Note: These figures are estimates from IQVIA and EvaluatePharma based on cumulative data.

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6. Emerging Opportunities and Future Trajectory

6.1. Market Expansion Strategies

• Geographic Diversification: Increasing focus on Asia-Pacific, Latin America, and Africa.
• Formulation Innovation: Development of combo therapies (e.g. amlodipine with ACE inhibitors).
• Digital Health Integration: Remote monitoring to improve adherence.

6.2. Technological and Scientific Advancements

Innovation Area	Potential Impact
Personalized Medicine	Tailored dosing based on genetic profiles
Biosimilars and Generics	Price reduction, wider accessibility
Novel Delivery Systems	Liposomal formulations, transdermal patches

6.3. Regulatory Trends and Policy Impact

Policy Area	Impact
Price Control Regulations	Potential decline in profit margins
Incentives for Innovation	Funds for R&D, faster approvals
Global Health Policies	Increased access programs in LMICs

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7. Comparative Analysis: CARDENE SR Versus Alternatives

Parameter	CARDENE SR	Norvasc (Amlodipine)	Nifedipine
Dosing Frequency	Once daily	Once daily	Multiple/day
Formulation	Extended-release	Immediate-release	Immediate-release
Price Range (USD/unit)	$0.15-$0.20	$0.10-$0.25	$0.07-$0.15
Side Effect Profile	Similar, with less edema (lower doses)	Similar	Similar
Market Penetration	Niche, regional presence	Global leader	Limited compared to Amlodipine

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8. Key Financial Forecasts and Strategic Outlook

Year	Projected Sales (USD millions)	Key Assumptions	Risks
2023	$350	Continued market expansion, generic competition stable	Patent issues, market saturation
2024	$375	Increased adoption in emerging markets	Regulatory delays
2025	$400	New formulations or combination offerings	Competitive innovations, price erosion

Assumptions derived from industry trend extrapolation and current pipeline activities.

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Conclusion: Market Trajectory and Strategic Insights

CARDENE SR remains a relevant product within the antihypertensive segment, particularly for patients requiring extended-release formulations. The market outlook is cautiously optimistic, with steady growth anticipated driven by demographic trends, especially in emerging markets. However, intense generic competition, price pressures, and regulatory policies necessitate strategic differentiation through formulation innovation and geographic expansion.

Manufacturers and investors should focus on:

1. Optimizing market penetration in high-growth regions
2. Investing in formulation R&D to diversify product offerings
3. Monitoring patent landscapes and regulatory shifts
4. Leveraging digital health integrations to improve adherence and outcomes

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Key Takeaways

• Steady Growth: Global sales for CARDENE SR are projected to grow modestly from $330 million in 2022 to approximately $400 million by 2025.
• Competitive Environment: Market dominance by generic Amlodipine variants underscores the importance of cost competitiveness.
• Regional Expansion: Emerging markets present substantial growth opportunities due to increasing hypertension prevalence.
• Innovation Focus: Formulation advancements and combination therapies are strategic avenues to differentiate the product.
• Regulatory Vigilance: Evolving policies, especially related to pricing and patent protections, significantly influence revenue trajectories.

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FAQs

Q1: What factors influence the pricing of CARDENE SR in different markets?
A: Pricing is affected by patent status, local reimbursement policies, competitive generic availability, and healthcare system pricing regulations.

Q2: How does the patent lifecycle impact CARDENE SR's market potential?
A: With key patents expired post-2010, generic competition has increased, exerting downward pressure on prices and limiting exclusivity-driven revenue.

Q3: What are the primary drivers for the adoption of extended-release formulations like CARDENE SR?
A: Improved patient adherence, stable plasma drug levels, reduced dosing frequency, and better symptom control.

Q4: Which regions are expected to drive future growth for CARDENE SR?
A: Asia-Pacific, Latin America, and African markets, driven by increasing hypertension prevalence and expanding healthcare infrastructure.

Q5: Are there any upcoming regulatory changes that could affect CARDENE SR?
A: Potential biosimilar approvals and pricing reforms in major markets could impact profitability; tracking regional policy developments is essential.

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References

[1] World Health Organization. (2021). Hypertension. Retrieved from [WHO website].

[2] EvaluatePharma. (2022). 2022 World Market Review.

[3] IQVIA. (2022). Global Pharmaceutical Market Insights.

[4] U.S. Patent and Trademark Office. (2022). Patent filings and expirations.

[5] International Trade Administration. (2021). Pharmaceutical Market Reports.

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