BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Benazepril hydrochloride; hydrochlorothiazide is the generic ingredient in two branded drugs marketed by Ani Pharms, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Ltd, and Validus Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	8
DailyMed Link:	BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
TSH Biopharm Corporation Limited	Phase 4
Ranbaxy Laboratories Limited	N/A

See all BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Drug Class	Angiotensin Converting Enzyme Inhibitor Thiazide Diuretic
Mechanism of Action	Angiotensin-converting Enzyme Inhibitors
Physiological Effect	Decreased Blood Pressure Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

US Patents and Regulatory Information for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076688-003	Feb 11, 2004		DISCN	No	No
Aurobindo Pharma Usa	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076688-002	Feb 11, 2004		DISCN	No	No
Ani Pharms	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076348-002	Feb 11, 2004		DISCN	No	No
Sandoz	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076631-001	Feb 11, 2004	AB	RX	No	No
Aurobindo Pharma Usa	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	076688-001	Feb 11, 2004		DISCN	No	No
Sun Pharm Inds Ltd	BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	077483-002	Sep 8, 2005		DISCN	No	No

Expired US Patents for BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-003	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-004	May 19, 1992
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-002	May 19, 1992

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benazepril Hydrochloride and Hydrochlorothiazide

Introduction to Benazepril Hydrochloride and Hydrochlorothiazide

Benazepril hydrochloride and hydrochlorothiazide are two medications often combined to treat hypertension and other cardiovascular conditions. Benazepril hydrochloride is an angiotensin-converting enzyme (ACE) inhibitor, while hydrochlorothiazide is a diuretic. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

Increasing Prevalence of Hypertension and Cardiovascular Diseases

The global prevalence of hypertension is a significant driver for the market growth of benazepril hydrochloride and hydrochlorothiazide. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[1].

Growing Geriatric Population

The aging population is more susceptible to hypertension and other cardiovascular diseases, which increases the demand for these medications. The global elderly population growth is a key factor driving the market expansion for benazepril hydrochloride and hydrochlorothiazide[3].

Advances in Pharmaceutical Research and Development

Continuous research and development efforts to improve the therapeutic efficacy and safety profiles of these drugs contribute to market growth. Novel formulations and generic versions of these medications, such as those approved by the FDA, further boost market demand[4].

Government Policies and Healthcare Spending

Government policies that encourage healthcare affordability and accessibility, along with rising healthcare expenditure, are significant factors driving the market. These policies help in increasing the accessibility of these medications to a broader population[3].

Market Trends

New Product Launches

The launch of new and generic versions of benazepril hydrochloride and hydrochlorothiazide tablets has been a trend in recent years. For example, Mylan received FDA approval for benazepril hydrochloride and hydrochlorothiazide tablets, which are the generic version of Novartis Pharmaceuticals' Lotensin HCT® Tablets[4].

Combination Therapies

Combination therapies, such as the one involving benazepril hydrochloride and hydrochlorothiazide, are gaining popularity due to their enhanced efficacy in managing hypertension and other cardiovascular conditions. Beximco Pharmaceuticals Ltd. launched Telma Plus, which contains hydrochlorothiazide and telmisartan, another example of a combination therapy[1].

Financial Trajectory

Market Size and Projections

The benazepril hydrochloride market was valued at USD 100 billion in 2023 and is expected to reach USD 147.75 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is driven by the increasing incidence of hypertension and chronic renal disease, as well as the growing elderly population[3].

Revenue Streams

The revenue for benazepril hydrochloride and hydrochlorothiazide comes from various segments, including prescription sales, hospital purchases, and government contracts. Medicare prescription drug plans, for instance, cover benazepril/hydrochlorothiazide, with 99% of plans including this medication, which contributes significantly to the revenue[5].

Key Players and Competitive Landscape

Major Pharmaceutical Companies

Companies such as Mylan, Novartis, Teva, and Beximco Pharmaceuticals are key players in the market. These companies invest heavily in research and development and have a strong distribution network, which helps in maintaining their market share[1][4].

Competitive Intensity

The market for benazepril hydrochloride and hydrochlorothiazide is highly competitive, with multiple generic and branded versions available. The competitive intensity is expected to increase as more pharmaceutical companies enter the market with new formulations and generic versions[1].

Challenges and Restraints

Side Effects and Safety Concerns

One of the significant challenges facing the market is the side effects associated with these medications. Both benazepril hydrochloride and hydrochlorothiazide can have adverse effects, which may hamper market growth if not adequately managed[1].

Regulatory Hurdles

Regulatory approvals and compliance with FDA guidelines are crucial for the launch of new products. Any delays or issues in the regulatory process can impact the financial trajectory of these drugs[4].

Regional Analysis

Global Distribution

The market for benazepril hydrochloride and hydrochlorothiazide is global, with significant demand in both developed and developing countries. The market growth is particularly high in regions with a large elderly population and increasing incidence of cardiovascular diseases[3].

Regional Market Share

The regional market share varies, with North America and Europe being significant markets due to high healthcare spending and a large elderly population. However, the market in Asia-Pacific is also growing rapidly due to increasing healthcare awareness and government initiatives[1].

Future Outlook

Continuous R&D and Innovation

The future outlook for benazepril hydrochloride and hydrochlorothiazide is positive, driven by continuous research and development efforts. New formulations and combination therapies are expected to enhance the market growth[3].

Increasing Healthcare Awareness

Rising awareness about cardiovascular health and the importance of preventative measures will continue to drive the demand for these medications. Government initiatives to improve healthcare accessibility will also contribute to the market's financial trajectory[3].

Key Takeaways

• The market for benazepril hydrochloride and hydrochlorothiazide is driven by the increasing prevalence of hypertension and cardiovascular diseases.
• The growing geriatric population and advances in pharmaceutical research are significant market drivers.
• Government policies and rising healthcare expenditure also contribute to market growth.
• The market faces challenges such as side effects and regulatory hurdles.
• Continuous R&D and increasing healthcare awareness are expected to drive the future market growth.

Frequently Asked Questions (FAQs)

Q: What are the primary drivers of the benazepril hydrochloride and hydrochlorothiazide market? A: The primary drivers include the increasing prevalence of hypertension and cardiovascular diseases, the growing geriatric population, and advances in pharmaceutical research and development.

Q: Which companies are key players in the benazepril hydrochloride and hydrochlorothiazide market? A: Key players include Mylan, Novartis, Teva, and Beximco Pharmaceuticals.

Q: What are the challenges facing the benazepril hydrochloride and hydrochlorothiazide market? A: The challenges include side effects associated with the medications and regulatory hurdles.

Q: How does the regional distribution of the market look? A: The market is global, with significant demand in both developed and developing countries, particularly in regions with a large elderly population.

Q: What is the future outlook for the benazepril hydrochloride and hydrochlorothiazide market? A: The future outlook is positive, driven by continuous R&D, increasing healthcare awareness, and government initiatives to improve healthcare accessibility.

Cited Sources:

1. Allied Market Research - Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
2. Taylor & Francis Online - Reversed-Phase High Performance Liquid Chromatographic and ...
3. Market Research Intellect - Benazepril Hydrochloride Market Size and Projections
4. Mylan Investor Relations - Mylan Receives FDA Approval for Benazepril Hydrochloride Tablets ...
5. GoodRx - Benazepril / HCTZ Medicare Coverage and Co-Pay Details - GoodRx