Hydrochlorothiazide; lisinopril - Generic Drug Details

What are the generic sources for hydrochlorothiazide; lisinopril and what is the scope of patent protection?

Hydrochlorothiazide; lisinopril is the generic ingredient in three branded drugs marketed by Aurobindo, Chartwell Rx, Corepharma, Epic Pharma Llc, Hikma Intl Pharms, Invagen Pharms, Lupin, Norvium Bioscience, Prinston Inc, Sandoz, Sun Pharm Inds Ltd, Teva, Watson Labs, Merck, and Almatica, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-two suppliers are listed for this compound.

Summary for hydrochlorothiazide; lisinopril

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	32
Clinical Trials:	12
DailyMed Link:	hydrochlorothiazide; lisinopril at DailyMed

Recent Clinical Trials for hydrochlorothiazide; lisinopril

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

Sponsor	Phase
The University of Texas Health Science Center, Houston	Phase 4
IPCA Laboratories Ltd.	Phase 1
Scripps Translational Science Institute	N/A

See all hydrochlorothiazide; lisinopril clinical trials

Pharmacology for hydrochlorothiazide; lisinopril

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 hydrochlorothiazide; lisinopril

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

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 hydrochlorothiazide; lisinopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Intl Pharms	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076265-003	Jul 8, 2002		DISCN	No	No
Hikma Intl Pharms	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076265-002	Jul 8, 2002		DISCN	No	No
Chartwell Rx	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	075776-001	Jul 1, 2002		DISCN	No	No
Lupin	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077912-003	Sep 27, 2006	AB	RX	No	No
Hikma Intl Pharms	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076265-001	Jul 8, 2002		DISCN	No	No
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989		DISCN	Yes	No

Expired US Patents for hydrochlorothiazide; lisinopril

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-003	Nov 18, 1993
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-003	Nov 18, 1993
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-002	Jul 20, 1989

Hydrochlorothiazide; lisinopril Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Lisinopril

Introduction

Hydrochlorothiazide and lisinopril are two widely used medications in the management of hypertension and related cardiovascular diseases. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Hydrochlorothiazide Market Dynamics

Key Drivers

• Increasing Prevalence of Hypertension: The global hydrochlorothiazide market is significantly driven by the rising prevalence of hypertension. According to the World Health Organization, approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to increase to 29% by 2025, particularly in economically developing nations[4].
• Geriatric Population: The aging population is more susceptible to chronic diseases such as high blood pressure and heart disease, contributing to the increased demand for hydrochlorothiazide[1][2].
• Combination Therapies: The trend towards combination drug therapies, where hydrochlorothiazide is used alongside other antihypertensives, enhances therapeutic effectiveness and boosts market growth[2].

Market Segmentation

• By Type: Hydrochlorothiazide is available in various forms, including tablets, capsules, and liquids. Each form has its own market share and demand based on patient preferences and medical requirements[4].
• By Application: The drug is used for treating hypertension, fluid retention, heart attacks, kidney failure, and other conditions. Hypertension remains the primary application driving market growth[4].
• By End User: Hospitals, drug stores, and other healthcare facilities are the main end users of hydrochlorothiazide[4].

Financial Trajectory

• Market Growth: The hydrochlorothiazide market is expected to see significant growth from 2021 to 2030, driven by increasing healthcare expenditure, research and development activities, and the launch of novel formulations[1][2][4].
• Investment Opportunities: Setting up a hydrochlorothiazide manufacturing plant involves substantial capital investments, but it offers promising returns due to the high demand for the drug. Detailed project reports provide insights into project economics, including capital investments, operating costs, and revenue projections[2].

Lisinopril Market Dynamics

Key Drivers

• Rising Prevalence of Hypertension and Cardiovascular Diseases: The increasing prevalence of hypertension and cardiovascular diseases, such as coronary heart disease, is a major driver for the lisinopril market. For instance, the prevalence of coronary heart disease among adults aged 18 and over increased from 4.6% in 2020 to 4.9% in 2021[3].
• Aging Population: The growing aging population, which is more prone to hypertension and heart diseases, contributes to the increased demand for lisinopril[3].
• Generic Versions and Cost-Effectiveness: The availability of generic versions of lisinopril and their cost-effectiveness are significant factors driving market growth[3].

Market Segmentation

• By Region: The lisinopril market is segmented by region, with North America being the largest market in 2023. The Asia-Pacific region is expected to be the fastest-growing region in the forecast period[3].
• By Product Type: Lisinopril is sold under various brand names, including Prinivil, Qbrelis, Zestoretic, Zestril, and Apo-lisinopril[3].

Financial Trajectory

• Market Size and Growth: The lisinopril market is expected to grow from $1.66 billion in 2023 to $2.26 billion by 2028, at a compound annual growth rate (CAGR) of 6.4%. This growth is attributed to the rising prevalence of hypertension and cardiovascular diseases, increased awareness, and early diagnosis[3].
• Revenue Projections: The market growth is also driven by innovations in drug delivery, the need for patient-centric approaches, and the demand for cost-effective solutions. These factors collectively contribute to the positive financial outlook for the lisinopril market[3].

Common Market Trends and Challenges

Combination Therapies

Both hydrochlorothiazide and lisinopril are often used in combination with other antihypertensive drugs to enhance therapeutic effectiveness. This trend is expected to continue, driving market growth for both drugs[2][3].

Research and Development

Ongoing research and development activities aimed at improving patient compliance and minimizing side effects are crucial for the growth of both markets. Novel formulations and drug delivery systems are being developed to address these issues[1][2][3].

Side Effects and Safety Concerns

Side effects associated with both hydrochlorothiazide and lisinopril can hamper market growth. For hydrochlorothiazide, side effects such as electrolyte imbalance and increased risk of kidney stones are concerns. For lisinopril, side effects like cough, dizziness, and increased potassium levels need to be managed[1][3].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the markets for hydrochlorothiazide and lisinopril. Increased healthcare expenditure and the demand for effective treatments have created opportunities for manufacturers, despite challenges in the supply chain[1].

Financial Analysis and Investment

Capital Investments and Operating Costs

Setting up manufacturing plants for both drugs requires substantial capital investments. Detailed financial analyses, including project economics, capital investments, operating costs, and revenue projections, are essential for making informed investment decisions[2].

Revenue Projections and ROI

Both markets are expected to generate significant revenue in the coming years. For hydrochlorothiazide, the market is forecasted to grow significantly from 2021 to 2030, while the lisinopril market is projected to grow to $2.26 billion by 2028. These projections indicate promising returns on investment for manufacturers and stakeholders[1][2][3].

Regional Market Analysis

Hydrochlorothiazide

The global hydrochlorothiazide market is segmented by region, with a strong presence in economically developing nations due to the increasing prevalence of hypertension and other cardiovascular diseases[4].

Lisinopril

The lisinopril market is dominated by North America, but the Asia-Pacific region is expected to be the fastest-growing region in the forecast period, driven by the rising prevalence of hypertension and cardiovascular diseases[3].

Key Takeaways

• The markets for hydrochlorothiazide and lisinopril are driven by the increasing prevalence of hypertension and cardiovascular diseases.
• Combination therapies and the availability of generic versions are key factors driving market growth.
• Ongoing research and development activities are crucial for improving patient compliance and minimizing side effects.
• The COVID-19 pandemic has created both challenges and opportunities for the pharmaceutical industry.
• Financial analyses and detailed project reports are essential for making informed investment decisions.

FAQs

1. What are the primary drivers of the hydrochlorothiazide market?

The primary drivers of the hydrochlorothiazide market include the increasing prevalence of hypertension, the growing geriatric population, and the rise in combination drug therapies.

2. How is the lisinopril market expected to grow in the coming years?

The lisinopril market is expected to grow from $1.66 billion in 2023 to $2.26 billion by 2028, at a CAGR of 6.4%, driven by the rising prevalence of hypertension and cardiovascular diseases.

3. What are the common side effects associated with hydrochlorothiazide and lisinopril?

Hydrochlorothiazide can cause side effects such as electrolyte imbalance and increased risk of kidney stones, while lisinopril can cause cough, dizziness, and increased potassium levels.

4. How has the COVID-19 pandemic impacted the markets for hydrochlorothiazide and lisinopril?

The COVID-19 pandemic has increased healthcare expenditure and the demand for effective treatments, creating opportunities for manufacturers despite supply chain challenges.

5. What are the key investment considerations for setting up a hydrochlorothiazide or lisinopril manufacturing plant?

Key investment considerations include capital investments, operating costs, revenue projections, and detailed financial analyses to ensure a positive return on investment.

Cited Sources:

1. Allied Market Research. Hydrochlorothiazide Market Size | Industry Growth, (2021-2030). Retrieved from https://www.alliedmarketresearch.com/hydrochlorothiazide-market-A14001
2. OpenPR. Hydrochlorothiazide Manufacturing Plant Project Report 2024. Retrieved from https://www.openpr.com/news/3571829/hydrochlorothiazide-manufacturing-plant-project-report-2024
3. Research and Markets. Lisinopril Global Market Report 2024. Retrieved from https://www.researchandmarkets.com/report/global-lisinopril-market
4. EIN Presswire. Hydrochlorothiazide Market To See Incredible Growth During 2021–2030. Retrieved from https://www.einpresswire.com/article/561001121/hydrochlorothiazide-market-to-see-incredible-growth-during-2021-2030