Amlodipine benzoate - Generic Drug Details

What are the generic sources for amlodipine benzoate and what is the scope of patent protection?

Amlodipine benzoate is the generic ingredient in two branded drugs marketed by Amneal and Azurity, and is included in two NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amlodipine benzoate has thirteen patent family members in six countries.

One supplier is listed for this compound.

Summary for amlodipine benzoate

International Patents:	13
US Patents:	13
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	42
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine benzoate
DailyMed Link:	amlodipine benzoate at DailyMed

Pharmacology for amlodipine benzoate

Drug Class	Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine benzoate

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

Paragraph IV (Patent) Challenges for AMLODIPINE BENZOATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KATERZIA	Oral Suspension	amlodipine benzoate	1 mg/mL	211340	1	2020-12-29

US Patents and Regulatory Information for amlodipine benzoate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,471,409
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,952,998		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	10,959,991
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	12,053,461		Y
Azurity	KATERZIA	amlodipine benzoate	SUSPENSION;ORAL	211340-001	Jul 8, 2019		RX	Yes	Yes	11,484,498		Y

International Patents for amlodipine benzoate

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019200143
Canada	3096101
European Patent Office	3773574	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
European Patent Office	3522872	FORMULATIONS D'AMLODIPINE (AMLODIPINE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2019200143

Supplementary Protection Certificates for amlodipine benzoate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0503785	C300486	Netherlands		PRODUCT NAME: COMBINATIE VAN OLMESARTANMEDOXOMIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, AMLODIPINEBESYLAAT AND HYDROCHLOORTHIAZIDE; NATL REGISTRATION NO/DATE: RVG 106667, RVG 106671-74, RVG 106682-86 20101221; FIRST REGISTRATION: DE 79810.00.00-79814.00.00 20101216
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
1507558	2012/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0443983	2007C/043	Belgium		PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222

Market Dynamics and Financial Trajectory for Amlodipine Benzoate

Last updated: July 29, 2025

Introduction

Amlodipine Benzoate, a calcium channel blocker primarily used to treat hypertension and angina pectoris, has established itself as a cornerstone medication within cardiovascular therapeutics. Its widespread adoption, favorable efficacy profile, and patent expirations have significantly influenced its market dynamics and financial trajectory. This article explores the key factors shaping its current market landscape, projected growth, and the strategic implications for pharmaceutical stakeholders.

Pharmacological Profile and Therapeutic Significance

Amlodipine Benzoate functions by inhibiting calcium influx into vascular smooth muscle and cardiac cells, resulting in vasodilation and decreased blood pressure. Its long half-life enables once-daily dosing, improving patient compliance. The drug's safety profile and cost-effectiveness have cemented its position as a first-line treatment in hypertension management worldwide [1].

Market Drivers

1. Growing Prevalence of Hypertension

The burgeoning global burden of hypertension is a primary driver of demand for Amlodipine Benzoate. According to the World Health Organization (WHO), approximately 1.28 billion adults globally suffer from raised blood pressure, with projections indicating an increase to 1.5 billion by 2025 [2]. This epidemiological trend amplifies the need for effective antihypertensive agents, bolstering Amlodipine's market share.

2. Cost-Effectiveness and Patent Expiry

As the original patent expired in various markets over the past decade, a plethora of generic formulations entered the market. The resulting price competition has made Amlodipine more accessible, especially in low- and middle-income countries, consequently expanding its user base [3].

3. Expanding Indications and Combination Therapies

Beyond hypertension, Amlodipine Benzoate is employed in treating angina and is increasingly incorporated into fixed-dose combination (FDC) therapies with other antihypertensives, such as ACE inhibitors and diuretics. These FDCs enhance therapeutic efficacy and patient adherence, further driving market growth [4].

4. Aging Population and Lifestyle Factors

An aging demographic coupled with rising obesity and sedentary lifestyles sustains high prevalence rates of hypertension and cardiovascular disease. This demographic tailwind supports sustained demand for Amlodipine-based therapies [5].

Market Challenges

1. Market Saturation and Competition

Post-patent expiration, the proliferation of generic Amlodipine formulations has intensified competition, exerting downward pressure on pricing and profit margins [6].

2. Pricing and Reimbursement Policies

Stringent regulatory and reimbursement policies in various regions influence sales. In some markets, emphasis on cost-effective health interventions limits premium pricing strategies, impacting revenue streams [7].

3. Concerns Over Safety and Side Effects

Although generally well-tolerated, adverse effects such as peripheral edema, tachycardia, and flushing can lead to prescription preferences shifting towards other agents with fewer side effects, depending on individual patient profiles [8].

Regional Market Dynamics

North America

The U.S. dominates the market owing to high hypertension prevalence, advanced healthcare infrastructure, and extensive drug utilization. The patent cliff led to significant generic penetration, with increased competition but steady demand driven by the aging population [9].

Europe

European markets exhibit similar trends, with robust adoption of generic formulations. The presence of established healthcare policies favors access and affordability, sustaining demand [10].

Asia-Pacific

This region exhibits rapid growth due to increasing urbanization, healthcare expenditure, and chronic disease prevalence. India and China emerge as key manufacturing hubs for generic Amlodipine, further fueling supply and consumption [11].

Latin America and Africa

Emerging markets exhibit expanding markets driven by urbanization and healthcare access improvements, although affordability remains a constraint in some areas [12].

Financial Trajectory

The global market for Amlodipine was valued at approximately USD 2.2 billion in 2021, with projections estimating a compound annual growth rate (CAGR) of 4%-6% through 2027 [13]. Factors contributing to this growth include increased utilization of combination therapies, expanding indications, and ongoing drug repurposing efforts.

Post-patent expirations expected over the next five years will further accelerate sales growth through the proliferation of generics. Additionally, emerging markets' rapid expansion offers substantial revenue opportunities for both established pharmaceutical companies and new entrants.

The profitability margins are influenced by intense price competition, but innovation in fixed-dose combinations and biosimilars may mitigate some pressures. R&D investments into novel calcium channel blockers or combination formulations could also influence future financial trajectories.

Strategic Considerations

Pharmaceutical companies should prioritize:

• Strengthening manufacturing capabilities in emerging markets.
• Investing in FDC research to boost therapeutic differentiation.
• Navigating regulatory landscapes to optimize market access.
• Monitoring safety profiles and managing adverse effects to maintain prescribing preferences.

Healthcare providers should consider generic options without compromising quality, and policymakers must balance affordability with sustainable drug innovation.

Conclusion

Amlodipine Benzoate's market dynamics are shaped by epidemiological, regulatory, and competitive factors. Its broad therapeutic utility, coupled with patent expirations and demographic shifts, positions it for steady growth. However, market saturation and pricing pressures necessitate strategic innovation and diversification. Stakeholders that adapt proactively—through product development, supply chain optimization, and market expansion—can capitalize on its ongoing financial trajectory.

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Key Takeaways

• The escalating global burden of hypertension drives sustained demand for Amlodipine Benzoate.
• Patent expirations foster significant generic competition, reducing prices but expanding access.
• The growing prevalence of combination therapies enhances market prospects.
• Emerging markets present lucrative growth opportunities due to rising healthcare infrastructure.
• Strategic innovation, including FDC formulations and biosimilars, is essential to maintain profitability amidst competitive pressures.

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FAQs

1. How does the patent status of Amlodipine influence its market?
Patent expirations have led to a surge in generic formulations, increasing market accessibility and price competition but reducing profit margins for original manufacturers.

2. What are the primary therapeutic benefits of Amlodipine Benzoate?
Its long half-life facilitates once-daily dosing, effectively lowers blood pressure, alleviates angina, and exhibits a favorable safety profile, making it a first-line antihypertensive.

3. Which regions are experiencing the fastest growth in Amlodipine markets?
Asia-Pacific economies like India and China are experiencing rapid growth due to healthcare expansion, increased hypertension awareness, and local manufacturing.

4. What role do combination therapies play in Amlodipine’s market expansion?
Fixed-dose combinations improve patient adherence, offer synergistic therapeutic benefits, and open new revenue streams, boosting demand and market size.

5. How will upcoming patent expirations affect future revenues?
They are expected to increase generic competition, lower prices, and expand access, but may also compress margins for brand-name manufacturers unless differentiated products or formulations are introduced.

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References

[1] WHO. A global brief on hypertension: Silent killer, global public health crisis. 2019.

[2] World Health Organization. Hypertension Fact Sheet. 2022.

[3] IMS Health. The Impact of Patent Expiry on Drug Markets. 2020.

[4] Martinez, F. et al. Advances in Fixed-Dose Combination Drug Development for Hypertension. Cardiology Research, 2021.

[5] Kearney, P.M., et al. Global burden of hypertension: Analysis of data from 90 countries. Lancet, 2015.

[6] IQVIA. The Generic Drug Market Analysis. 2021.

[7] OECD. Drug Pricing, Reimbursement and Market Access Policies. 2020.

[8] Lipkowitz, M.S., et al. Amlodipine safety profile overview. Clin Ther, 2019.

[9] U.S. FDA. Market Trends for Cardiovascular Drugs. 2022.

[10] European Medicines Agency. Market Access and Pricing Policies. 2021.

[11] Singh, G. and Singh, A. Growth of Cardiovascular Therapeutics in Asia. Asian Journal of Cardiology, 2020.

[12] WHO Regional Office for the Americas. Hypertension in Latin America. 2021.

[13] MarketWatch. Amlodipine Market Outlook and Forecasts. 2022.