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, Dr Reddys Labs Inc, Heritage, Lupin Pharms, Norvium Bioscience, Strides Pharma, 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.

Fifteen 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:	11
NDAs:	13
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	39
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
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077183-004	Apr 15, 2010	AB	RX	No	No
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	090149-001	Jul 5, 2011	AB	RX	No	No
Amneal	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077215-004	Dec 7, 2018		DISCN	No	No
Heritage	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	091431-005	Dec 30, 2013	AB	RX	No	No
Dr Reddys Labs Inc	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077183-003	Apr 15, 2010	AB	RX	No	No
Teva Pharms	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	077179-002	May 18, 2007		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	020364-004	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
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

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amlodipine Besylate and Benazepril Hydrochloride

Introduction

Amlodipine besylate and benazepril hydrochloride are widely used medications for treating hypertension and heart diseases. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Global Market Size and Growth

The global amlodipine besylate market has been experiencing steady growth. As of 2023, the market size was recorded at USD 1,867.0 million, with projections indicating it will reach USD 1,933.0 million in 2024 and USD 2,539.5 million by 2031, growing at a CAGR of 3.98% from 2024 to 2031[3].

Market Segmentation

The market is segmented based on product type, applications, and regions.

By Type

• The market includes various strengths of amlodipine besylate tablets, such as 2.5 mg, 5 mg, and 10 mg[1][4].

By Application

• The primary applications are for treating high blood pressure and heart diseases[1][4].

By Region

• North America dominates the market with a share of around 34.56% in 2023, due to high prevalence of hypertension, advanced healthcare infrastructure, and high healthcare spending[3].
• The Asia Pacific region is poised for rapid growth, registering a CAGR of 5.09% during the forecast period, driven by increasing awareness about cardiovascular health and government initiatives promoting preventive healthcare[3].

Drivers of Market Growth

Several factors are driving the growth of the amlodipine besylate market:

Increasing Prevalence of Hypertension and Cardiovascular Diseases

• Approximately 1.28 million adults aged 30-79 in low and middle-income countries suffer from hypertension, with many unaware of their condition[3].

Technological Advancements and Healthcare Infrastructure

• Improvements in healthcare infrastructure and the adoption of rapid testing and point-of-care diagnosis are fueling market growth[1].

Investments in Research and Development

• Increasing investments in the pharmaceutical sector, drug discovery developments, and funding by public and private sectors are boosting market revenue growth[1].

Competitive Landscape

The amlodipine besylate market features a robust competitive landscape with numerous global and regional pharmaceutical companies. Key players include:

• Pfizer
• Mylan
• Reddy’s Laboratories
• Apotex
• Teva Pharmaceutical
• Cipla
• Hikma Pharmaceuticals
• Strides Pharma
• Upsher-Smith Laboratories
• InvaGen Pharmaceuticals[3].

Challenges

Despite the growth, the market faces several challenges:

Fierce Competition from Generic Drugs

• The market faces significant competition from generic drugs, leading to price erosion and reduced profit margins for manufacturers. To overcome this, pharmaceutical companies must focus on differentiating their products through improved formulations and combination therapies[3].

Supply Dynamics

• The demand for amlodipine besylate is continuously growing, but it is often met with supply challenges. For instance, global prices surged in March 2024 due to peak demand and dwindling supplies, particularly post-Chinese New Year when manufacturing slows down in China[3].

Pharmacoeconomic Impact

Amlodipine besylate has shown cost-effectiveness in treating coronary artery disease (CAD). A study in Italy highlighted that adding amlodipine besylate to standard care reduced major vascular events and revascularization procedures, resulting in significant savings in hospital expenditures[3].

Combination Therapy with Benazepril Hydrochloride

Amlodipine besylate is often combined with benazepril hydrochloride to enhance antihypertensive effects. This combination therapy is effective in doses of 2.5 mg to 10 mg of amlodipine and 10 mg to 80 mg of benazepril. The antihypertensive effect is largely attained within 2 weeks, and the therapy is usually initiated after a patient has failed to achieve the desired effect with monotherapy or has developed edema with amlodipine alone[2][5].

Dosage and Administration

• Amlodipine besylate and benazepril hydrochloride capsules are administered once daily, with doses starting at 2.5/10 mg for patients ≥75 years old or those with hepatic impairment[2].
• The therapy needs to account for renal function, with the capsules not recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m^2)[2].

Side Effects and Discontinuation

• Common side effects include cough and edema, with discontinuation of therapy required in approximately 4% of patients treated with amlodipine besylate and benazepril hydrochloride[2].

Regional Outlook

North America

• Dominates the market due to high prevalence of hypertension and cardiovascular diseases, advanced healthcare infrastructure, and high healthcare spending[3].

Asia Pacific

• Poised for rapid growth driven by increasing awareness about cardiovascular health, rising prevalence of hypertension, and government initiatives promoting preventive healthcare[3].

Market Projections and Forecast

The global amlodipine besylate market is expected to continue its upward trajectory, driven by the increasing prevalence of cardiovascular diseases, advancements in pharmaceutical formulations, and the growing adoption of online retail channels. By 2031, the market is projected to reach USD 2,539.5 million at a CAGR of 3.98% during the forecast period[3].

Key Takeaways

• The global amlodipine besylate market is growing steadily, driven by the rising prevalence of hypertension and cardiovascular diseases.
• The market is segmented by form and sales channel, with online retail expected to see significant growth.
• North America and the Asia Pacific region are key markets, with the latter experiencing rapid growth.
• The competitive landscape is robust, with major pharmaceutical companies competing for market share.
• Lifestyle factors and digital health initiatives are influencing market dynamics.

FAQs

What are the primary applications of amlodipine besylate?

• The primary applications are for treating high blood pressure and heart diseases[1][4].

Which regions dominate the amlodipine besylate market?

• North America dominates the market, followed by the Asia Pacific region, which is poised for rapid growth[3].

What are the key drivers of the amlodipine besylate market growth?

• Increasing prevalence of hypertension and cardiovascular diseases, technological advancements, and investments in research and development are key drivers[1][3].

How does the combination therapy with benazepril hydrochloride work?

• The combination therapy enhances antihypertensive effects, with doses starting at 2.5/10 mg and the effect largely attained within 2 weeks[2][5].

What are the common side effects of amlodipine besylate and benazepril hydrochloride?

• Common side effects include cough and edema, with discontinuation of therapy required in approximately 4% of patients[2].

Sources

1. Reports and Data: Amlodipine Besylate Market Size, Industry Statistics, Growth Potentials, Trends, Company Profile, Global Expansion Strategies by Top Key Vendors Till 2027.
2. DailyMed: Amlodipine Besylate and Benazepril Hydrochloride.
3. Drug Patent Watch: Generic AMLODIPINE BESYLATE INN equivalents, drug patent.
4. Market Research Future: Amlodipine Besylate Market Size, Share & Forecast Report 2032.
5. FDA: Lotrel (amlodipine besylate and benazepril hydrochloride) Label.