Amlodipine besylate; perindopril arginine - Generic Drug Details

What are the generic sources for amlodipine besylate; perindopril arginine and what is the scope of freedom to operate?

Amlodipine besylate; perindopril arginine is the generic ingredient in one branded drug marketed by Adhera and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Amlodipine besylate; perindopril arginine has thirty patent family members in twenty-seven countries.

Summary for amlodipine besylate; perindopril arginine

International Patents:	30
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amlodipine besylate; perindopril arginine
DailyMed Link:	amlodipine besylate; perindopril arginine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for amlodipine besylate; perindopril arginine

Constraining patent/regulatory exclusivity:

7,846,961

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for amlodipine besylate; perindopril arginine

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

Sponsor	Phase
Symplmed Pharmaceuticals LLC	Phase 3

See all amlodipine besylate; perindopril arginine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for amlodipine besylate; perindopril arginine

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

C09AA	ACE inhibitors, plain
C09A	ACE INHIBITORS, PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for AMLODIPINE BESYLATE; PERINDOPRIL ARGININE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRESTALIA	Tablets	amlodipine besylate; perindopril arginine	3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg	205003	1	2016-11-04

US Patents and Regulatory Information for amlodipine besylate; perindopril arginine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015		DISCN	Yes	No	7,846,961		Y	Y

Expired US Patents for amlodipine besylate; perindopril arginine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-001	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-002	Jan 21, 2015	6,696,481
Adhera	PRESTALIA	amlodipine besylate; perindopril arginine	TABLET;ORAL	205003-003	Jan 21, 2015	6,696,481

International Patents for amlodipine besylate; perindopril arginine

Country	Patent Number	Title	Estimated Expiration
Canada	2644467
Slovenia	1989182
Ukraine	89905	α КРИСТАЛЛИЧЕСКАЯ ФОРМА АРГИНИНОВОЙ СОЛИ ПЕРИНДОПРИЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ЕЕ СОДЕРЖИТ;α-КРИСТАЛІЧНА ФОРМА АРГІНІНОВОЇ СОЛІ ПЕРИНДОПРИЛУ, СПОСІБ ЇЇ ОДЕРЖАННЯ І ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЯКА ЇЇ МІСТИТЬ (α-CRYSTALLINE FORM OF PERINDOPRIL ARGININE SALT, METHOD FOR MAKING SAME, AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME)
Georgia, Republic of	P20125433	α CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT
European Patent Office	1989182
Brazil	PI0708278

Supplementary Protection Certificates for amlodipine besylate; perindopril arginine

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
1003503	05C0048	France		PRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Perindopril Arginine

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for antihypertensive agents has experienced significant evolution over recent decades. Among the cornerstone medications are Amlodipine Besylate, a calcium channel blocker, and Perindopril Arginine, an angiotensin-converting enzyme (ACE) inhibitor. These drugs play pivotal roles in managing hypertension and cardiovascular disease, with their market growth influenced by evolving clinical guidelines, regulatory feedback, demographic shifts, and competitive dynamics. This report analyzes the current market situational factors and forecasts the financial trajectory for these agents within the global pharmaceutical industry.

Market Overview

Amlodipine Besylate

Amlodipine Besylate is widely prescribed for hypertension and angina pectoris. Its favorable pharmacokinetics, once-daily dosing, and proven efficacy position it as a leading calcium channel blocker worldwide. The drug's global sales surpassed $3 billion annually pre-pandemic, with the Asia-Pacific region representing the fastest-growing market segment due to rising hypertension prevalence and healthcare infrastructure developments (IQVIA National Sales Perspectives, 2021).

Perindopril Arginine

Perindopril Arginine functions predominantly in hypertension and heart failure management. Its market is characterized by a broad patient base, especially in Europe and Asia, driven by established clinical evidence and physician familiarity. Although competitive with other ACE inhibitors, its differentiated pharmacokinetic profile sustains steady demand. Worldwide, annual sales are estimated around $1.5 billion, with emerging markets contributing to ongoing expansion.

Market Dynamics

Demographic and Epidemiological Factors

The global aging population exerts a pivotal influence on demand for antihypertensive therapies, including amlodipine and perindopril. As life expectancy increases, the prevalence of hypertension and related cardiovascular complications surges, creating sustained demand. According to the World Health Organization, approximately 1.28 billion adults worldwide suffered from hypertension in 2021, with projections indicating a 15% increase by 2030.

Regulatory and Clinical Guideline Shifts

Regulatory bodies such as the FDA and EMA continue to endorse these drugs based on robust clinical data. The American College of Cardiology/American Heart Association (ACC/AHA) recommends initial therapy with either calcium channel blockers or ACE inhibitors, depending on patient profiles, favoring the market for these agents. The introduction of generic equivalents has further reduced costs, expanding accessibility and market penetration.

Competition and Patent Landscape

Patent expirations for key formulations have driven the transition toward generics, intensifying price competition. Notably, the patent for Norvasc (Amlodipine) expired in 2014 in the US, leading to a proliferation of generics that capture over 80% of the US amlodipine market (FDA Orange Book). Similarly, patent cliffs for perindopril-containing formulations are anticipated within the next 3-5 years. Such dynamics foster price competition but also pose challenges for branded drug revenues.

Technological and Formulation Innovations

Advancements in sustained-release formulations and combination therapies enhance patient adherence, expanding market opportunity. Fixed-dose combinations incorporating amlodipine and perindopril are gaining popularity for their simplified regimen and improved compliance, projecting increasing sales trajectories.

Healthcare Infrastructure and Accessibility

Emerging markets such as India, China, and Southeast Asia experience rapid healthcare infrastructure growth, increasing drug access. Public health initiatives targeting non-communicable diseases prioritize antihypertensives, fostering growth in low- and middle-income economies.

Financial Trajectory

Current Revenue Trends

As of 2022, Amlodipine Besylate retains its position as the most commercially successful calcium channel blocker, with regional variations influenced by generic competition. Key manufacturers such as Pfizer, AstraZeneca, and Teva hold significant market shares.

Perindopril Arginine demonstrates resilient performance, particularly in European markets where ACE inhibitors are recommended as first-line therapy. The drug's sales are influenced by national prescribing habits and reimbursement policies, with Novartis (perindopril parent molecule) dominating the segment.

Market Forecast (2023-2030)

Projections indicate a compounded annual growth rate (CAGR) of approximately 3-5% for amlodipine and 2-4% for perindopril globally, driven by demographic factors and technological innovation. The Asia-Pacific region is expected to outperform other markets, with a CAGR of 6-8%, due to population growth and increasing hypertension awareness.

Impact of Patent Expirations

Generic entry post-patent expiry significantly compresses margins but expands overall volume sales. Industry estimates suggest that, post-2025, branded sales could decline by 15-20%, while total market revenues stabilize owing to increased utilization.

Emerging Opportunities

Market consolidation, biosimilar and combination product development, and expanding access in underserved regions will shape future financial landscapes. Pharmaceutical companies investing in formulation improvements and digital adherence solutions may realize premium pricing and market share gains.

Regulatory and Policy Influences

Prescription Reimbursement and Price Controls

Price regulation in countries like India, China, and European nations imposes constraints but also fosters affordability and broadens access, indirectly supporting volume growth. Health technology assessment (HTA) agencies increasingly analyze cost-effectiveness data, influencing formulary decisions.

Patent and Intellectual Property Developments

Strategic patent filings for new formulations, delivery systems, and combination therapies provide revenue buffers and market exclusivity, influencing future profitability.

Conclusion

The market for amlodipine besylate and perindopril arginine remains robust, driven by aging populations, increasing hypertension prevalence, and evolving treatment paradigms. While patent expirations challenge branded formulations, the overall sales trajectory remains positive owing to emerging markets, technological enhancements, and the adoption of combination therapies. Stakeholders investing in research, formulation innovation, and regional expansion are positioned to capitalize on this sustained growth phase.

Key Takeaways

• Global demand for antihypertensive agents like amlodipine and perindopril is reinforced by demographic aging and heightened cardiovascular health awareness.
• Patent expirations foster price competition but also spur growth in generics and combination therapies, influencing revenue patterns.
• Emerging markets present lucrative avenues, with regional CAGR projections exceeding 6%, driven by infrastructure development and non-communicable disease management initiatives.
• Technological innovations in formulation and adherence solutions provide opportunities for premium pricing and market differentiation.
• Regulatory landscapes necessitate strategic planning regarding pricing, reimbursement, and patent protections to maximize profitability.

FAQs

1. What are the primary factors influencing the market growth of amlodipine besylate and perindopril arginine?
Demographic shifts toward aging populations, rising hypertension prevalence, technological advances in formulations, and expansion in emerging markets primarily drive market growth.

2. How do patent expirations affect the revenue streams for these drugs?
Patent expirations lead to increased generic competition, reducing prices and profit margins but expanding overall volume sales as affordability improves.

3. Are combination therapies a significant trend in this market?
Yes. Fixed-dose combinations integrating amlodipine and perindopril are increasingly adopted to improve patient adherence and clinical outcomes, opening new revenue channels.

4. What role do regulatory policies play in shaping this market?
Regulatory agencies influence market dynamics through approval, pricing, and reimbursement policies, which can either facilitate wider access or introduce constraints depending on regional strategies.

5. Which regions are expected to see the fastest growth for these antihypertensive agents?
The Asia-Pacific region, particularly China and India, exhibits the highest growth rates due to demographic factors, improving healthcare infrastructure, and governmental initiatives addressing non-communicable diseases.

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Sources:

1. IQVIA National Sales Perspectives, 2021.
2. World Health Organization, 2021. Hypertension Fact Sheet.
3. FDA Orange Book, 2022.
4. Market Analysis Reports, 2022.
5. European Society of Cardiology Guidelines, 2021.