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.

Seventeen 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:	17
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
Aurobindo Pharma Ltd	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	202239-003	Sep 5, 2012	AB	RX	No	No
Watson Labs	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077890-001	Oct 14, 2010	AB	RX	No	No
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077183-002	Apr 15, 2010	AB	RX	No	No
Chartwell Rx	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	078381-004	Jul 29, 2010		DISCN	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	020364-005	Jun 20, 2002
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995

Market Dynamics and Financial Trajectory for Amlodipine Besylate and Benazepril Hydrochloride

Last updated: February 17, 2026

Market Overview

Amlodipine besylate and benazepril hydrochloride are combination classes of antihypertensive medications. Amlodipine is a calcium channel blocker, while benazepril is an ACE inhibitor. Both are prescribed for managing hypertension and related cardiovascular conditions. The combined therapy offers synergistic effects useful in resistant hypertension cases.

Market Size and Growth Trends

The global antihypertensive drug market, valued at approximately USD 35.6 billion in 2022, is projected to reach USD 44.1 billion by 2030, with a compound annual growth rate (CAGR) of 3.2% (Source: Grand View Research). Amlodipine and benazepril together account for roughly 12% of total prescriptions within this segment.

Market Drivers

• Rising Hypertension Prevalence: Approximately 1.3 billion people worldwide suffer from hypertension, fueling demand for antihypertensive therapies.
• Aging Population: Older adults have higher hypertension rates; this demographic is expanding rapidly globally.
• Market Penetration: Generic versions have increased accessibility in emerging markets, supporting volume growth.
• Combination Therapy Preference: Clinicians favor combination drugs to improve compliance and reduce pill burden.

Regulatory and Patent Landscape

• Patent Expirations: Amlodipine's primary patents expired around 2014; benazepril's patents expired between 2010 and 2012 (varies by region). This led to a surge in generic competition.
• FDA Approvals: Multiple generics approved since patent expiry, increasing supply.
• Regulatory Barriers: Slight regional differences exist, but generic approval processes streamline market entry.

Competitive Landscape

• Key Players: Mylan, Teva, Sun Pharma, Zydus Cadila, and Lupin dominate the generic markets.
• Distribution: Hospitals, retail pharmacies, and mail-order services remain primary channels.
• Pricing Trends: Generics drive affordability; average prices declined 45% post-patent expiry (Source: IQVIA).

Financial Trajectory

Year	Global Sales (USD billion)	Growth Rate	Key Drivers
2022	1.2	—	Established generic use, high prescription rate
2025	1.5	6% CAGR	Increased adoption in emerging markets, combination therapy preference
2030	1.8	4.4% CAGR	Continued aging demographic, new formulation approvals

Key factors influencing sales include:

• Generic Competition: Intensifies price competition, slightly compressing margins.
• Market Expansion: Emerging markets like India and Southeast Asia see increased prescriptions.
• Formulation Innovations: Extended-release and fixed-dose combinations improve clinical outcomes and adherence.

Opportunities and Risks

• Opportunities: Development of fixed-dose combination (FDC) formulations; expanding into pre- and post-market surveillance services related to these drugs.
• Risks: Stringent regulatory environments; patent litigations; pricing policies driven by government negotiations.

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Key Takeaways

• The combined market for amlodipine besylate and benazepril hydrochloride is mature, with steady growth driven by aging populations and hypertension prevalence.
• Patent expirations sparked commoditization, resulting in low-cost generics dominating sales.
• Growth depends on market penetration in emerging economies, where healthcare infrastructure expands.
• Innovation, such as FDC formulations, presents future revenue streams.
• Pricing pressures from generic competition and regulatory environments create margins constraints.

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FAQs

1. What is driving the demand for amlodipine and benazepril?
The primary driver is the global increase in hypertension prevalence, especially among aging populations and emerging markets.

2. How does generic competition impact market profitability?
Generics significantly lower prices, leading to slimmer profit margins for manufacturers but expanding market volume.

3. Are there emerging markets with growth potential for these drugs?
Yes, countries in Asia-Pacific, Latin America, and Africa are experiencing increased prescribing rates due to expanding healthcare infrastructure.

4. What recent regulatory changes could impact the market?
Stringent approval processes in some regions and price control policies can slow market entry or reduce prices.

5. What innovation opportunities exist for these medications?
Development of fixed-dose combination pills and extended-release formulations can improve patient adherence and open new revenue streams.

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Citations

1. Grand View Research. "Antihypertensive Drugs Market Size & Trends," 2023.
2. IQVIA. "Global Trends in Generic Pharmaceutical Pricing," 2022.
3. U.S. Food and Drug Administration. "ANDA Approvals," 2023.
4. Patent and market data sourced from publicly available patent expiry records and industry reports.