LOPRESSOR HCT Drug Patent Profile

When do Lopressor Hct patents expire, and what generic alternatives are available?

Lopressor Hct is a drug marketed by Validus Pharms and is included in one NDA.

The generic ingredient in LOPRESSOR HCT is hydrochlorothiazide; metoprolol tartrate. There are thirty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; metoprolol tartrate profile page.

Summary for LOPRESSOR HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	26
Patent Applications:	4,247
Drug Prices:	Drug price information for LOPRESSOR HCT
What excipients (inactive ingredients) are in LOPRESSOR HCT?	LOPRESSOR HCT excipients list
DailyMed Link:	LOPRESSOR HCT at DailyMed

See drug prices for LOPRESSOR HCT

Recent Clinical Trials for LOPRESSOR HCT

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 2
National Center for Advancing Translational Science (NCATS)	Phase 2
Corcept Therapeutics	Phase 1

See all LOPRESSOR HCT clinical trials

Pharmacology for LOPRESSOR HCT

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

US Patents and Regulatory Information for LOPRESSOR HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-001	Dec 31, 1984	AB	RX	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984		DISCN	Yes	No
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984		DISCN	Yes	No

Expired US Patents for LOPRESSOR HCT

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
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-003	Dec 31, 1984
Validus Pharms	LOPRESSOR HCT	hydrochlorothiazide; metoprolol tartrate	TABLET;ORAL	018303-002	Dec 31, 1984

International Patents for LOPRESSOR HCT

See the table below for patents covering LOPRESSOR HCT around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	982140	PHENOXY-HYDROXYPROPYLAMINES AND THEIR PREPARATION
Norway	132798
Austria	307386
Japan	S5317587
Switzerland	563340

Supplementary Protection Certificates for LOPRESSOR HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216

Market Dynamics and Financial Trajectory for LOPRESSOR HCT

Last updated: July 28, 2025

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Introduction

LOPRESSOR HCT, a combination medication comprising propranolol and hydrochlorothiazide, is primarily indicated for the management of hypertension and certain cardiovascular conditions. As a generic formulation with established efficacy, its market presence is influenced by evolving healthcare trends, regulatory landscapes, and competitive dynamics. This analysis explores the current market environment, growth drivers, challenges, and financial prospects shaping the future trajectory of LOPRESSOR HCT.

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Pharmacological Profile and Therapeutic Positioning

LOPRESSOR HCT merges two well-established agents: propranolol, a non-selective beta-blocker, and hydrochlorothiazide, a thiazide diuretic. The combination offers a synergistic approach to blood pressure control, reducing cardiovascular risk factors associated with hypertension. Its longstanding clinical acceptance and proven safety profile underpin its persistent demand across global markets, especially in regions with high hypertension prevalence ([1]).

The pharmacokinetics and efficacy records reinforce its role in combination therapy, often prescribed when monotherapy fails to achieve target blood pressure levels. Its formulatory stability and patent expirations facilitate broad generic manufacturing, intensifying market competition.

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Market Dynamics

Global Prevalence of Hypertension and Associated Demand

The increasing global burden of hypertension presents a fundamental growth driver. According to the World Health Organization (WHO), over 1.28 billion adults worldwide have hypertension, with developing nations reporting the fastest growth rates ([2]). The escalating demand for effective antihypertensive therapies, including fixed-dose combinations like LOPRESSOR HCT, reflects this epidemiological trend.

Regulatory Environment and Patent Landscape

LOPRESSOR HCT, lacking patent protection due to its age and generic status, benefits from a competitive pricing environment. Regulatory agencies such as the FDA and EMA facilitate access for multiple manufacturers, driving affordability but also intensifying price competition. Conversely, in some markets, patent protections might still exist due to formulation-specific patents, influencing market exclusivity periods.

Prescriber Preferences and Clinical Guidelines

Current clinical guidelines, including those from the American College of Cardiology (ACC) and the American Heart Association (AHA), endorse combination therapy for hypertension management. Fixed-dose combinations improve adherence and simplify regimens, elevating LOPRESSOR HCT’s appeal among prescribers. Its use is also supported in patients with comorbid conditions, such as arrhythmias and migraine prophylaxis, adding to its market scope.

Market Competition

LOPRESSOR HCT faces competition from various proprietary fixed-dose combinations, such as atenolol with chlorthalidone, or newer agents like ARBs paired with diuretics. The competitive landscape is further influenced by generic proliferation, which compresses margins but sustains volume-based revenues.

Emergence of Novel Therapeutics and Biosimilars

Advances in antihypertensive therapies, including novel drug classes like direct renin inhibitors and mineralocorticoid receptor antagonists, are reshaping the treatment algorithm. Nonetheless, the entrenched clinical utility and low cost of LOPRESSOR HCT sustain its market position, especially in lower-income tiers and emerging markets.

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Financial Trajectory

Revenue Trends and Sales Performance

As a generic product, LOPRESSOR HCT’s revenues are generally aligned with global hypertension prevalence and healthcare expenditure. The Asia-Pacific and Latin America markets show high growth potential due to expanding healthcare access and increasing hypertension awareness.

According to IQVIA data, the global sales of propranolol-based combination therapies have exhibited modest growth, primarily driven by volume rather than price. Over the past five years, sales of LOPRESSOR HCT have stabilized or slightly declined in mature markets, reflecting generic price erosion. However, demand remains robust in developing economies where access to newer, often costlier therapies is limited ([3]).

Market Penetration and Pricing Strategies

Manufacturers leverage competitive pricing, bundling, and regional formulations to penetrate local markets. Bulk procurement by healthcare systems and inclusion in essential medicines lists influence demand stability. Differentiation is limited due to the generic nature but can be achieved via formulation improvements and supply chain efficiencies.

Impact of Healthcare Policies

Health insurance coverage and government reimbursement policies directly influence drug utilization. Countries adopting universal health coverage facilitate higher access, benefiting sales of established generics like LOPRESSOR HCT. Conversely, policies favoring newer therapies or price controls can suppress revenue growth.

Future Revenue Outlook

Predicting precise revenue trajectories necessitates considering demographic shifts, regulatory changes, and market competition. Based on current trends, global sales are expected to plateau in mature markets but sustain growth in emerging economies. The continued emphasis on hypertension control and adherence strategies supports ongoing demand, although margins may diminish due to pricing competition.

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Market Challenges and Opportunities

Challenges

• Price Erosion: Intense generic competition suppresses profit margins.
• Emerging Therapies: Availability of new antihypertensives may divert prescriptions.
• Regulatory Barriers: Variations in approval processes can hinder market entry or expansion.
• Limited Differentiation: Generic status limits branding or value-added features.

Opportunities

• Expanding in Emerging Markets: Increasing prevalence and healthcare infrastructure growth drive demand.
• Formulation Innovations: Developing fixed-dose combinations with other agents can open new indications.
• Partnerships and Licensing: Alliances with regional manufacturers expand reach.
• Adherence Campaigns: Clinician and patient engagement improve usage, stabilizing demand.

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Conclusion

LOPRESSOR HCT’s market dynamics are shaped by the escalating global burden of hypertension, regulatory landscapes fostering generic proliferation, and the competitive dominance of well-established pharmaceutical agents. Financially, while near-term revenues are constrained by price pressures, the drug maintains stable demand due to its clinical efficacy and affordability, especially in underserved markets.

The future trajectory hinges on strategic market penetration, formulation enhancements, and navigating evolving healthcare policies. For stakeholders, balancing cost competitiveness with pharmaceutical integrity will be crucial to sustain financial performance amid a competitive environment.

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Key Takeaways

• Robust Demand in Emerging Markets: Population growth and rising hypertension rates underpin sustained sales.
• Price Competition Dominates: Generic proliferation and regional pricing pressures limit profit margins.
• Adherence and Combination Therapy Trends Favor LOPRESSOR HCT: Fixed-dose regimens improve compliance, enhancing market adoption.
• Competition from Newer Agents and Biosimilars: Continual innovation may challenge the drug’s market share in mature economies.
• Opportunities for Market Expansion: Strategic partnerships and formulation innovations can bolster long-term growth prospects.

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FAQs

1. What factors influence the global sales of LOPRESSOR HCT?
Sales are primarily driven by hypertension prevalence, healthcare infrastructure, regulatory policies, and competitive dynamics, especially in emerging markets where affordability is crucial.

2. How does patent expiration impact LOPRESSOR HCT’s market?
Patent expiration facilitates the entry of generic manufacturers, increasing supply, reducing prices, and stabilizing demand, though it diminishes profit margins for originators.

3. Are there any recent innovations related to LOPRESSOR HCT?
While no significant recent innovations directly pertain to LOPRESSOR HCT, formulation improvements and fixed-dose combinatorial approaches with newer agents could influence its market relevance.

4. What are the key challenges facing LOPRESSOR HCT in the current market?
Price erosion, competition from newer antihypertensives, regulatory hurdles, and limited differentiation are primary challenges.

5. What strategic actions can enhance LOPRESSOR HCT’s market position?
Expanding to underserved regions, engaging in licensing agreements, optimizing formulations, and aligning with global health initiatives can support sustained demand.

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Sources

1. Clinical Pharmacology of Propranolol and Hydrochlorothiazide.
2. WHO Hypertension Fact Sheet. World Health Organization, 2021.
3. IQVIA Medicine Data, 2022.