AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for amlodipine besylate; benazepril hydrochloride and what is the scope of freedom to operate?

Amlodipine besylate; benazepril hydrochloride is the generic ingredient in two branded drugs marketed by Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Pharmobedient, Rising, Teva Pharms, Watson Labs, Watson Labs Inc, and Sandoz, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
DailyMed Link:	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Novartis Pharmaceuticals	Phase 4
Dr. Reddy's Laboratories Limited	Phase 1

See all AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		10MG; 20MG	CAPSULE; ORAL
		5MG; 20MG	CAPSULE; ORAL
		5MG; 10MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Drug Class	Angiotensin Converting Enzyme Inhibitor Calcium Channel Blocker Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Decreased Blood Pressure

Anatomical Therapeutic Chemical (ATC) Classes for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

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; BENAZEPRIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	5 mg/40 mg and 10 mg/40 mg	020364	1	2006-11-17
LOTREL	Capsules	amlodipine besylate; benazepril hydrochloride	2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg	020364	1	2004-06-09

US Patents and Regulatory Information for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	078381-003	Jul 29, 2010		DISCN	No	No
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-007	Apr 11, 2006	AB	RX	Yes	No
Chartwell Rx	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	078381-004	Jul 29, 2010		DISCN	No	No
Heritage	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	091431-002	Dec 30, 2013	AB	RX	No	No

Expired US Patents for AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-007	Apr 11, 2006
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Benazepril Hydrochloride

Last updated: July 30, 2025

---

Introduction

The pharmaceutical landscape for antihypertensive drugs has evolved significantly over the past decade, driven by an aging global population, rising prevalence of cardiovascular diseases (CVD), and advancing therapeutic options. Two prominent agents in this domain are amlodipine besylate and benazepril hydrochloride. Understanding the market dynamics and financial trajectories for these drugs requires analyzing their clinical positioning, competitive landscape, regulatory environment, and economic factors influencing their demand and supply.

---

Market Overview

Amlodipine besylate and benazepril hydrochloride are cornerstone medications in managing hypertension and associated cardiovascular risks. Amlodipine, a dihydropyridine calcium channel blocker, offers potent vasodilatory effects, while benazepril, an angiotensin-converting enzyme (ACE) inhibitor, modulates the renin-angiotensin-aldosterone system (RAAS). Their combined use, either as monotherapy or in fixed-dose combinations, reflects current treatment strategies aligned with clinical guidelines emphasizing blood pressure control and organ protection.

---

Market Drivers

Growing Prevalence of Hypertension and Cardiovascular Diseases

The global burden of hypertension affects approximately 1.28 billion adults, with projections suggesting continued growth due to lifestyle changes, aging demographics, and urbanization [1]. This uptrend amplifies demand for antihypertensive medications like amlodipine and benazepril.

Aging Population and Chronic Disease Management

Elderly populations are particularly vulnerable to hypertension and related CVD, driving persistent prescriptions for these agents. The World Health Organization reports that by 2050, the proportion of people aged 60 years and above will double, intensifying the market for antihypertensive drugs [2].

Advancement of Therapeutic Strategies

The adoption of fixed-dose combination therapies enhances compliance and improves therapeutic outcomes, leading to higher market penetration for drug formulations combining amlodipine and benazepril.

---

Market Challenges

Patent Expirations and Generic Competition

Several branded formulations of amlodipine and benazepril have faced patent cliffs over the past few years, leading to a surge in generic alternatives. This commoditization exerts pressure on prices but also broadens accessibility.

Regulatory and Reimbursement Policies

Varying regulatory frameworks and reimbursement policies across regions influence drug pricing, availability, and prescribing patterns, impacting revenue streams.

Emergence of Novel Therapeutics

Emerging antihypertensive agents with improved efficacy or fewer side effects—such as ARNI (angiotensin receptor-neprilysin inhibitors)—introduce competitive pressures.

---

Financial Trajectory Analysis

Market Revenue and Growth Patterns

The global antihypertensive market was valued at approximately USD 26 billion in 2021, with calcium channel blockers and ACE inhibitors constituting major segments [3]. The segment for amlodipine specifically accounts for a sizable share owing to its widespread use.

Projected Compound Annual Growth Rate (CAGR) for antihypertensives remains steady at around 3-4% through 2028, driven by expanding markets and increased treatment rates [4].

Region-specific Trends

• North America: Dominates due to high hypertension awareness and insurance coverage, with a CAGR of 2.5% projected.
• Europe: Stabilized growth, influenced by stringent regulations but high disease prevalence.
• Asia-Pacific: Fastest growth, with CAGR estimates of 5-6%, driven by rising healthcare infrastructure and urbanization.

Pricing and Reimbursement Impact

Pricing strategies are affected by generic competition, with prices reducing by as much as 70% post-patent expiry, though revenues compensate through volume increases.

Market Entry and Innovation

New formulations (e.g., sustained-release, combination therapies) expand revenue streams, with pharmaceutical companies investing heavily in R&D to differentiate products.

---

Key Stakeholders and Market Dynamics

• Pharmaceutical Manufacturers: Focus on portfolio expansion through generic manufacturing, biosimilars, and fixed-dose combinations.
• Healthcare Providers: Preference for combination therapies to streamline patient management.
• Regulatory Bodies: Stringent approval processes affecting new entrants.
• Payers and Insurers: Balance between drug efficacy and cost containment.

---

Future Outlook

The market for amlodipine besylate and benazepril hydrochloride is poised for moderated but sustained growth, pivoting towards newer formulations and combination therapies. Innovations aimed at improving tolerability and compliance, coupled with digital health integration, are anticipated to influence the financial trajectory positively.

Emerging regions offer substantial growth potential, contingent upon infrastructural and policy improvements, while patent expiries will continue to reshape the competitive landscape in mature markets.

---

Key Factors Influencing Market Financials

Factor	Impact
Patent expirations	Decreased prices, increased volume sales
Regulatory environment	Faster approvals but stringent standards
Healthcare access	Growth in emerging markets
R&D investments	Development of novel formulations and combinations
Competitive dynamics	Price wars and innovation incentives

---

Conclusion

The market dynamics and financial trajectory of amlodipine besylate and benazepril hydrochloride are characterized by steady growth driven by global hypertension prevalence, aging demographics, and therapeutic innovation. While challenges from generics and regulatory hurdles persist, strategic diversification and emerging market expansion are key to sustained revenues.

---

Key Takeaways

• Demand sustains growth: Rising global hypertension rates ensure continued demand, particularly in the Asia-Pacific region.
• Patent expiries reshape revenues: Generics significantly reduce pricing but increase volume sales.
• Innovation is pivotal: Fixed-dose combinations and novel formulations enhance market competitiveness.
• Emerging markets are lucrative: Rapid urbanization and healthcare improvements unlock new revenue streams.
• Regulatory and reimbursement policies will remain critical determinants of market access and profitability.

---

FAQs

1. How do patent expiries affect the profitability of amlodipine and benazepril?
Patent expiries lead to the introduction of generic versions, drastically lowering drug prices. While individual product margins decline, overall sales volume often rises, sustaining revenue streams for manufacturers with broad portfolios and efficient production.

2. What role do fixed-dose combination therapies play in the market?
They improve patient compliance, reduce pill burden, and are aligned with current clinical guidelines, bolstering market growth and providing competitive advantages for pharmaceutical companies.

3. Which regions are experiencing the fastest growth for these drugs?
The Asia-Pacific region exhibits the highest CAGR, driven by increasing hypertension prevalence, expanding healthcare infrastructure, and favorable regulatory policies.

4. How are regulatory changes influencing the market?
Stringent regulations can delay product approvals and increase costs but also promote safety and efficacy standards, fostering trust and long-term market stability.

5. What emerging innovations might impact the future financial trajectory?
Development of combination therapies with improved safety profiles, long-acting formulations, and personalized medication approaches are poised to sustain market relevance and profitability.

---

References

[1] WHO. Hypertension. World Health Organization. 2022.
[2] United Nations. World Population Ageing 2020 Highlights.
[3] Grand View Research. Antihypertensive Drugs Market Size & Trends. 2022.
[4] IQVIA. The Global Use of Medicines in 2021.