HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE - Generic Drug Details

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

Hydrochlorothiazide; metoprolol tartrate is the generic ingredient in two branded drugs marketed by Validus Pharms, Alembic, Mylan, Senores Pharms, and Sun Pharm Inds, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	6
Clinical Trials:	3
DailyMed Link:	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1
Vanderbilt University	Phase 1
Vanderbilt University Medical Center	Phase 1

See all HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Drug Class	Thiazide Diuretic beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

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

C07AB	Beta blocking agents, selective
C07A	BETA BLOCKING AGENTS
C07	BETA BLOCKING AGENTS
C	Cardiovascular system

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	202870-003	Nov 6, 2013	AB	RX	No	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984		DISCN	Yes	No
Mylan	METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	076792-003	Aug 20, 2004	AB	RX	No	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984		DISCN	Yes	No

Expired US Patents for HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	3,876,802
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984	3,998,790
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984	3,876,802

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Metoprolol Tartrate

Last updated: July 29, 2025

Introduction

Hydrochlorothiazide (HCTZ) and Metoprolol Tartrate are longstanding HCP (highly prescribed) medications used primarily for hypertension and cardiovascular conditions. Their established efficacy, safety profiles, and affordability have sustained significant demand over decades, even as new therapies emerge. Analyzing their market dynamics and projecting the future financial trajectory requires understanding factors influencing their utilization, regulatory environment, manufacturing landscape, and evolving healthcare trends.

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Market Overview

Hydrochlorothiazide (HCTZ):

Hydrochlorothiazide, a thiazide diuretic, remains among the most prescribed antihypertensives globally. Its affordability, widespread availability, and extensive clinical evidence contribute to consistent demand. Despite the emergence of newer antihypertensive classes, HCTZ retains a central position in combination therapies, especially as a first-line agent.

Metoprolol Tartrate:

Metoprolol Tartrate, a cardioselective beta-blocker, is used extensively for hypertension, angina, and post-myocardial infarction management. It is preferred owing to its favorable side effect profile, especially in patients with respiratory conditions. Its patent expiry and generic availability have stabilized its market share, maintaining it as a staple cardio-drug.

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Market Dynamics

1. Patent Expiry and Generic Competition

Both drugs have long histories of patent expiration. The loss of patent protection has led to proliferation of generic versions, significantly reducing prices (~80-90% reduction). This has spurred fierce price competition but also increased accessibility, particularly in low- and middle-income countries.

2. Pricing Strategies and Reimbursement Policies

Price erosion due to generics has shifted revenue models toward volume sales. Reimbursement policies, especially in developed markets like the U.S. and Europe, influence prescribing behaviors. Payors favor cost-effective therapies; thus, products like HCTZ and Metoprolol Tartrate benefit from formulary preferences, sustaining steady demand.

3. Clinical Guidelines and Prescribing Trends

Guidelines from the American Heart Association and European Society of Cardiology continue to endorse thiazide diuretics and beta-blockers as first-line or add-on treatments in hypertension management. However, recent trials suggest a nuanced approach, with some data questioning the superiority of beta-blockers in initial monotherapy, slightly affecting prescriber preferences.

4. Emergence of New Therapeutics

Novel agents such as SGLT2 inhibitors, ARNI (angiotensin receptor-neprilysin inhibitors), and combination pills are gradually penetrating the market, posing slight pressure on traditional monotherapies. Nonetheless, cost and long-term familiarity favor continued use of HCTZ and Metoprolol.

5. Regulatory and Patent Re-Examinations

While initial patents have lapsed, some secondary patents or exclusive formulations may delay generic entry in certain jurisdictions. Regulatory bodies increasingly scrutinize off-patent drugs for quality, supply chain integrity, and biosimilar development.

6. Manufacturing and Supply Chain Outlook

Global supply chains, especially post-COVID-19, have experienced disruptions affecting raw material availability and production capacity. Nonetheless, HCTZ and Metoprolol, produced at scale, benefit from resilient manufacturing footprints, ensuring steady supply.

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Financial Trajectory Analysis

Current Revenue Snapshot

Estimates suggest that globally, combined sales for HCTZ and Metoprolol Tartrate exceed several billion USD annually, driven predominantly by volume sales in North America, Europe, and Asia-Pacific. The U.S. remains the largest market, attributed to high hypertension prevalence and a legacy prescribing pattern.

Forecasting Future Trends

• Stable Demand with Slight Decline: Given their entrenched status and generics market, revenues are expected to trend modestly downward but stabilize due to volume-based models and ongoing prescribing.

• Cost Pressures and Price Erosion: Continued pricing pressures in mature markets may exert downward revenue adjustments, but volume increases, especially in emerging markets, will counterbalance this effect.

• Emerging Markets Growth: Growth in healthcare access and chronic disease prevalence is expected to boost demand in regions like Asia, Latin America, and Africa.

• Line Extensions and Fixed-Dose Combinations: Pharmaceutical companies are developing combination pills (e.g., hydrochlorothiazide with custom antihypertensives), which may extend product lifecycles and revenue streams.

• Potential Regulatory and Patent Resolutions: Future patent litigations or regulatory changes could influence market access and pricing strategies, impacting revenues accordingly.

Investment Implications

Investors should recognize the low-margin, high-volume nature of these products. Firms with efficient manufacturing capabilities and resilient supply chains are better positioned to maintain profitability. Conversely, increased competition and regulatory scrutiny could pressure margins.

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Key Market Drivers

Driver	Impact	Future Outlook
Patent Expiry	Price erosion, increased generics	Long-term decline in per-unit prices, volume-driven revenues
Clinical Guidelines	Prescribing behavior	Steady demand if guidelines favor generic-based therapy
Healthcare Access	Market expansion	Growth in emerging markets
Therapeutic Innovation	Competition from new drugs	Slight market share erosion but limited for established generics
Supply Chain Stability	Ensures availability	Critical for consistent revenue streams

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Regulatory and Ethical Considerations

Regulatory trends favor generic drug quality and bioequivalence standards, which ensure trust but can also introduce batch variability concerns. Ethical manufacturing practices support market growth, especially in developing regions. Regulatory agencies' approval processes remain stringent, particularly for new formulations or combination therapies.

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Conclusion

Hydrochlorothiazide and Metoprolol Tartrate sustain a mature but resilient market driven by their affordability, early-line status, and broad clinical acceptance. While patent expiry has accelerated generic competition, stable demand persists through cost-effectiveness and guideline endorsement. The future financial trajectory suggests slow decline in revenue per unit but sustained profitability via volume increases, particularly in growing healthcare markets.

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Key Takeaways

• Persistent Demand: Both drugs remain vital in hypertension and cardiovascular management, with demand driven by clinical guidelines and cost considerations.

• Generics and Price Competition: Patent expirations have led to widespread generic availability, significantly reducing prices but expanding access.

• Market Stabilizers: Reimbursement policies, clinical endorsement, and manufacturing capacity secure ongoing revenues despite competition.

• Emerging Markets: Growth opportunities are prominent in Asia-Pacific and Latin America, mitigating declines in mature markets.

• Strategic Opportunities: Developing fixed-dose combinations and exploring biosimilar or formulation innovations can extend product relevance.

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FAQs

Q1: How will patent expiries impact the revenue of Hydrochlorothiazide and Metoprolol Tartrate?
A: Patent expiries have led to widespread generic competition, significantly reducing individual unit prices. However, overall revenues remain stable due to high prescription volumes, especially in emerging markets where access is expanding.

Q2: Are there any recent regulatory challenges affecting these drugs?
A: Regulatory agencies continue to enforce quality standards for generics, but no significant recent regulatory hurdles have threatened their market standing. Future challenges could arise from evolving bioequivalence standards or safety concerns.

Q3: What role do combination therapies play in this market?
A: Fixed-dose combination pills incorporating Hydrochlorothiazide or Metoprolol Tartrate are increasingly popular, enhancing adherence and extending product lifecycle and revenue streams.

Q4: How might the emergence of novel antihypertensive agents affect these drugs?
A: While newer therapies like SGLT2 inhibitors and ARNI may shift some treatment paradigms, the affordability and long-standing clinical data of Hydrochlorothiazide and Metoprolol ensure their continued use as first or adjunct therapies.

Q5: What are the growth prospects in emerging markets?
A: Significant growth is anticipated due to rising hypertension prevalence, increased healthcare infrastructure, and expanding pharmaceutical access, which can offset declines in mature economies.

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Sources:

1. [1] IMS Health Data on Global Cardiovascular Medications
2. [2] European Medicines Agency (EMA) and U.S. FDA Regulatory Publications
3. [3] MarketResearch.com Reports on Generic Pharmaceutical Market Trends
4. [4] GlobalData Healthcare Analytics on Hypertension Treatment
5. [5] WHO Global Health Observatory Data on Cardiovascular Disease Prevalence