HYDROCHLOROTHIAZIDE; LISINOPRIL - Generic Drug Details

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

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, Pharmobedient, 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.

Twenty-eight suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; LISINOPRIL

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	28
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
Lupin	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077912-002	Sep 27, 2006	AB	RX	No	No
Teva	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	075869-002	Jul 1, 2002		DISCN	No	No
Sandoz	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076262-003	Jul 1, 2002	AB	RX	No	No
Invagen Pharms	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	204058-002	May 23, 2017	AB	RX	No	Yes
Prinston Inc	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076230-002	Jul 1, 2002	AB	RX	No	No
Aurobindo	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	077606-001	Mar 14, 2006	AB	RX	No	No
Sandoz	LISINOPRIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	076262-001	Jul 1, 2002	AB	RX	No	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	019888-003	Nov 18, 1993	4,374,829*PED
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-002	Jul 20, 1989	4,472,380
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-003	Nov 18, 1993	4,374,829*PED
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-003	Nov 18, 1993	4,472,380
Almatica	ZESTORETIC	hydrochlorothiazide; lisinopril	TABLET;ORAL	019888-001	Sep 20, 1990	4,374,829*PED
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-002	Feb 16, 1989	4,472,380
Merck	PRINZIDE	hydrochlorothiazide; lisinopril	TABLET;ORAL	019778-001	Feb 16, 1989	4,472,380

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Lisinopril

Last updated: July 29, 2025

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Introduction

Hydrochlorothiazide and Lisinopril stand as cornerstone drugs in the management of hypertension and related cardiovascular conditions. Their long-standing presence in the pharmaceutical landscape has shaped market dynamics and financial trajectories, driven by evolving healthcare policies, patent landscapes, and clinical guidelines. This analysis examines the current market environment, growth prospects, and the major factors influencing the financial trajectory of these medications.

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Overview of Hydrochlorothiazide and Lisinopril

Hydrochlorothiazide, a thiazide diuretic, has been a mainstay in hypertension management since its approval in the 1950s. Its mechanism involves promoting diuresis and reducing blood volume, thereby diminishing blood pressure. Lisinopril, an ACE inhibitor, entered the market in the 1990s, offering a different mode of action and a favorable profile for patients with comorbidities such as heart failure and diabetic nephropathy.

Both drugs have established biosimilar markets following patent expirations—Hydrochlorothiazide in many regions by the early 2000s, and Lisinopril in the late 2010s—significantly impacting their pricing, market share, and overall revenue streams.

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Market Dynamics

1. Patent Expirations and Generic Competition

The expiration of patents for both Hydrochlorothiazide (around the early 2000s) and Lisinopril (2018 in the U.S.) marked pivotal moments, leading to widespread genericization. This transition fosters intense price competition, compresses profit margins, and shifts market share towards low-cost generic manufacturers.

2. Clinical Guidelines and Prescription Trends

Contemporary guidelines, including those from the American College of Cardiology and the American Heart Association, endorse a combination of ACE inhibitors like Lisinopril or diuretics like Hydrochlorothiazide as frontline therapy for hypertension. The preference for fixed-dose combination therapies and outpatient management fuels consistent prescription volumes of generic Lisinopril and Hydrochlorothiazide.

3. Market Penetration and Access

Developing markets have seen increasing acceptance of these generic medications owing to lower costs, expanding patient access. In many low- and middle-income countries, these drugs form a significant portion of antihypertensive treatment regimens.

4. Regulatory Environment

Stringent regulatory standards, especially regarding biosimilar and generic drug approvals, influence market entry and competition. Efforts to streamline regulatory pathways, notably in regions like the EU and the U.S., aim to boost generic supply, affecting prices and revenue.

5. Supply Chain Factors

Global supply chain disruptions—exacerbated during the COVID-19 pandemic—have temporarily impacted availability but typically do not significantly alter long-term market dynamics for these established drugs.

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Financial Trajectory

1. Revenue Trends

Pre-patent expiration, innovator brands generated substantial revenue; post-expiration, generics dominate, leading to drastic reductions in unit prices but sustained high-volume sales. Estimates show Lisinopril's global sales declined by over 50% in the immediate aftermath of patent expiry, stabilizing at lower levels but representing still-significant revenues given widespread global use.

2. Market Share Distribution

Global market share now favors low-cost generics. In the U.S., the MarketScan database indicates over 90% of prescriptions for Lisinopril and Hydrochlorothiazide are filled by generics, fostering price competition and cumulative revenues in the billions of dollars annually.

3. Emerging Opportunities

Growing application of these drugs in combination therapies, especially fixed-dose combinations (FDCs) such as Lisinopril-Hydrochlorothiazide, accelerates market volumes. The pipeline also sees investigational generic versions from emerging markets and biosimilars poised to expand competition further.

4. Pricing Dynamics

Price erosion is a persistent trend, with average wholesale prices for both drugs declining approximately 20-30% post-genericization. However, loyalty to established brands and formulary preferences in certain healthcare systems mitigate some of this decline.

5. Impact of Healthcare Policies

Introduction of value-based care and formulary restrictions favor low-cost generics and biosimilars, potentially compressing margins further but ensuring substantial volume sales. Governments emphasizing budget-conscious approaches accelerate generic uptake.

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Future Outlook and Influencing Factors

1. Market Growth Projection

The global antihypertensive drugs market is projected to reach USD 35 billion by 2028 [2], with Hydrochlorothiazide and Lisinopril accounting for a sizable portion due to their widespread use. Compound annual growth rate (CAGR) estimates for the generic segment hover around 4-5%, driven by rising hypertension prevalence and increased generic adoption.

2. Innovation and New Formulations

Limited innovation surrounds these drugs, with focus shifting towards complex combination therapies and delivery systems to maintain market relevance. Biosimilars and new fixed-dose combinations will likely sustain revenue streams.

3. Regulatory and Patent Trends

Continued expiration of patents and regulatory approvals for biosimilars or alternative therapies could heighten competition and influence market share distributions. Policy incentives for affordable medicines endorse generic and biosimilar proliferation.

4. Demographic Shifts and Disease Burden

The global increase in hypertension, linked to aging populations and lifestyle factors, endorses steady demand. Emerging markets will contribute significantly to growth, where affordability remains a key determinant.

5. Market Risks

Potential risks include regulatory hurdles, pricing pressures, and shifting clinical guidelines that favor newer agents with improved efficacy or safety profiles. Additionally, patent litigations and supply chain vulnerabilities may affect revenues unpredictably.

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Key Takeaways

• Market saturation: Post-patent expiration, Hydrochlorothiazide and Lisinopril's markets have transitioned into high-volume, low-margin environments dominated by generics.
• Growth drivers: Increasing hypertension prevalence, aging populations, and the proliferation of fixed-dose combinations sustain demand.
• Competitive landscape: Price pressures from generics and biosimilars form the core market dynamic. New formulations and combination therapies serve as growth avenues.
• Regulatory influence: Evolving policies favor generic and biosimilar proliferation, impacting pricing and market share.
• Future prospects: Despite limited innovation, steady demand driven by global health trends and demographic shifts positions these drugs as stable revenue contributors within the antihypertensive segment.

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FAQs

1. How does patent expiration influence the financial performance of Hydrochlorothiazide and Lisinopril?
Patent expirations facilitate rapid penetration of generic competitors, significantly reducing prices and profit margins for brand-name manufacturers. This shift often results in a decline in revenues for innovators but creates substantial opportunities for generics manufacturers, maintaining high utilization volumes.

2. What are the primary factors driving growth in the global market for these drugs?
Factors include rising hypertension prevalence, expanding healthcare access in emerging markets, adoption of combination therapies, and healthcare policies promoting cost-effective treatments.

3. How are regulatory frameworks affecting market competition?
Stringent approval processes for generics and biosimilars influence market entry and pricing strategies. Streamlined pathways and policy incentives foster increased competition, further driving prices down.

4. What avenues exist for revenue growth despite generic competition?
Development of fixed-dose combination therapies, novel delivery systems, and biosimilars offer avenues for differentiation and revenue retention.

5. What risks could impact the long-term financial stability of these drugs?
Regulatory hurdles, market saturation, pricing pressures, and the emergence of newer, more efficacious drugs could affect long-term revenues.

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Sources

[1] IMS Health Data, 2022.
[2] MarketsandMarkets Research Report, 2023.