CAPTOPRIL; HYDROCHLOROTHIAZIDE - Generic Drug Details

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

Captopril; hydrochlorothiazide is the generic ingredient in five branded drugs marketed by Apothecon, Cosette, Ivax Sub Teva Pharms, Rising, Strides Pharma, and Watson Labs, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for CAPTOPRIL; HYDROCHLOROTHIAZIDE

US Patents:	0
Tradenames:	5
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	CAPTOPRIL; HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for CAPTOPRIL; HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
GlaxoSmithKline	Phase 1
West China Hospital	Phase 4
Vanderbilt University Medical Center	Phase 1

See all CAPTOPRIL; HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for CAPTOPRIL; HYDROCHLOROTHIAZIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for CAPTOPRIL; 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 CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074896-004	Dec 29, 1997		RX	No	Yes
Rising	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074896-002	Dec 29, 1997		RX	No	Yes
Apothecon	CAPOZIDE 50/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-003	Oct 12, 1984		DISCN	Yes	No
Watson Labs	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074832-001	Dec 29, 1997		DISCN	No	No
Rising	CAPTOPRIL AND HYDROCHLOROTHIAZIDE	captopril; hydrochlorothiazide	TABLET;ORAL	074896-001	Dec 29, 1997		RX	No	No

Expired US Patents for CAPTOPRIL; HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	CAPOZIDE 50/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-004	Oct 12, 1984
Apothecon	CAPOZIDE 25/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-001	Oct 12, 1984
Apothecon	CAPOZIDE 50/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-003	Oct 12, 1984
Apothecon	CAPOZIDE 50/15	captopril; hydrochlorothiazide	TABLET;ORAL	018709-004	Oct 12, 1984
Apothecon	CAPOZIDE 25/25	captopril; hydrochlorothiazide	TABLET;ORAL	018709-002	Oct 12, 1984

CAPTOPRIL; HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Captopril and Hydrochlorothiazide

Introduction

Captopril and hydrochlorothiazide are two widely used medications in the management of hypertension and heart failure. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

Several factors drive the market growth for captopril and hydrochlorothiazide:

Increasing Prevalence of Hypertension

The global prevalence of hypertension is on the rise, with the World Health Organization (WHO) estimating that 1.13 billion people suffer from hypertension, a number expected to increase to 29% by 2025[1].

Aging Population

The increase in the geriatric population is another significant driver, as older individuals are more likely to develop hypertension and other cardiovascular diseases[1].

Advancements in Pharmaceutical Formulations

Continuous advancements in pharmaceutical formulations, including fixed-dose combinations like captopril and hydrochlorothiazide, enhance patient compliance and treatment efficacy[3].

Market Trends

Fixed-Dose Combinations

The use of fixed-dose combinations, such as captopril and hydrochlorothiazide tablets, is gaining traction due to their convenience and improved patient adherence. These combinations are often more effective in managing hypertension than single-agent therapies[4].

New Product Launches

Pharmaceutical companies are launching novel formulations and combinations, which helps in expanding the market. For instance, the combination of captopril and hydrochlorothiazide is widely used and has seen significant market growth[1].

Financial Trajectory

Market Size and Growth

The global antihypertensive drugs market, which includes captopril and hydrochlorothiazide, is projected to grow significantly. The market size for antihypertensive drugs is expected to increase from 2021 to 2031, driven by the increasing prevalence of hypertension and other cardiovascular diseases[4].

CAGR and Revenue Forecast

The valsartan hydrochlorothiazide preparation market, a related segment, is expected to reach USD 0.30 billion by 2032, growing at a CAGR of 4.5%. This growth trend is indicative of the broader antihypertensive market, which includes captopril and hydrochlorothiazide[3].

Key Market Players

Several pharmaceutical companies are key players in the market for captopril and hydrochlorothiazide, including:

• Teva
• Novartis
• Aurobindo Pharma
• Mylan
• Torrent Pharmaceuticals
• Zhejiang Huahai Pharmaceutical

These companies are involved in the development, manufacturing, and distribution of these medications, contributing to the market's growth and competitiveness[1].

Pharmacological and Clinical Aspects

Mechanism of Action

Captopril works by suppressing the renin-angiotensin-aldosterone system, reducing peripheral arterial resistance and blood pressure. Hydrochlorothiazide, a diuretic, helps in reducing fluid retention and lowering blood pressure[2].

Clinical Trials and Outcomes

Studies like the Captopril Prevention Project (CAPPP) have evaluated the efficacy of captopril compared to conventional therapies. While captopril showed a trend toward lower cardiovascular mortality, it had a higher incidence of stroke, highlighting the need for careful patient selection and monitoring[5].

Challenges and Restraints

Side Effects and Safety Concerns

Both captopril and hydrochlorothiazide have potential side effects that can hamper market growth. Captopril is associated with risks such as neutropenia and agranulocytosis, particularly in patients with impaired renal function or collagen vascular diseases. Hydrochlorothiazide can cause electrolyte imbalances and other adverse effects[2].

Regulatory and Market Competition

The market is highly competitive, with numerous antihypertensive drugs available. Regulatory approvals and compliance with safety standards are critical for maintaining market share[1].

Regional Market Analysis

The global market for antihypertensive drugs, including captopril and hydrochlorothiazide, is segmented by region:

• North America: A significant market due to high healthcare expenditure and a large patient population.
• Europe: Another major market with a high prevalence of hypertension.
• Asia Pacific: Rapidly growing due to increasing healthcare awareness and economic development.
• Latin America: Growing market driven by increasing healthcare needs and economic growth[4].

Key Takeaways

• The market for captopril and hydrochlorothiazide is driven by the increasing prevalence of hypertension and the aging population.
• Fixed-dose combinations and new product launches are key trends.
• The market is expected to grow significantly, with a notable CAGR.
• Major pharmaceutical companies are key players in this market.
• Side effects and safety concerns are significant restraints.
• Regional markets vary in growth potential and healthcare expenditure.

FAQs

1. What is the primary use of captopril and hydrochlorothiazide?

   • Captopril and hydrochlorothiazide are primarily used for the treatment of hypertension and heart failure.

2. What are the key drivers of the market for these drugs?

   • The increasing prevalence of hypertension, the aging population, and advancements in pharmaceutical formulations are key drivers.

3. Which companies are major players in this market?

   • Companies like Teva, Novartis, Aurobindo Pharma, Mylan, and Torrent Pharmaceuticals are major players.

4. What are the potential side effects of captopril and hydrochlorothiazide?

   • Captopril can cause neutropenia and agranulocytosis, while hydrochlorothiazide can cause electrolyte imbalances and other adverse effects.

5. How is the market segmented regionally?

   • The market is segmented into North America, Europe, Asia Pacific, Latin America, and the Rest of the World.

Cited Sources

1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
2. Drugs.com: Captopril and Hydrochlorothiazide Tablet: Package Insert
3. Business Research Insights: Valsartan Hydrochlorothiazide Preparation Market Size 2032
4. iHealthcareAnalyst: Antihypertensive Drugs Market and Forecast 2024-2031
5. American College of Cardiology: Captopril Prevention Project - CAPPP