LOTENSIN HCT Drug Patent Profile

Which patents cover Lotensin Hct, and what generic alternatives are available?

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

The generic ingredient in LOTENSIN HCT is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lotensin Hct

A generic version of LOTENSIN HCT was approved as benazepril hydrochloride; hydrochlorothiazide by ANI PHARMS on February 11^th, 2004.

Summary for LOTENSIN HCT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	13
Patent Applications:	4,233
Drug Prices:	Drug price information for LOTENSIN HCT
What excipients (inactive ingredients) are in LOTENSIN HCT?	LOTENSIN HCT excipients list
DailyMed Link:	LOTENSIN HCT at DailyMed

See drug prices for LOTENSIN HCT

Recent Clinical Trials for LOTENSIN HCT

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

Sponsor	Phase
Nanjing Children's Hospital	Phase 2
University of Nebraska	Phase 4
Peking University First Hospital	Phase 1/Phase 2

See all LOTENSIN HCT clinical trials

Pharmacology for LOTENSIN HCT

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

US Patents and Regulatory Information for LOTENSIN 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	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992		DISCN	Yes	No
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-003	May 19, 1992	AB	RX	Yes	Yes
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-002	May 19, 1992	AB	RX	Yes	No

Expired US Patents for LOTENSIN HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-001	May 19, 1992	4,410,520*PED
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-003	May 19, 1992	4,410,520*PED
Validus Pharms	LOTENSIN HCT	benazepril hydrochloride; hydrochlorothiazide	TABLET;ORAL	020033-004	May 19, 1992	4,410,520*PED

International Patents for LOTENSIN HCT

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

Country	Patent Number	Title	Estimated Expiration
Spain	526888
Ireland	821929
Argentina	242190	PROCEDIMIENTO PARA OBTENER NOVEDOSOS ACIDOS 3-(5-AMINOPENTIL)-AMINO-1-BENZACEPIN-2-ONA-1-ALCANOICOS. (3-AMINO-(1)-BENZAZEPIN-2-ONE-1-ALKANOIC ACIDS)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LOTENSIN HCT

Last updated: July 28, 2025

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Introduction

LOTENSIN HCT, a fixed-dose combination comprising triamterene and hydrochlorothiazide, stands as a vital antihypertensive medication. Its pharmacological profile offers precise blood pressure management, particularly in resistant hypertension and edema cases. As regulatory approvals expand and the global hypertension burden rises, understanding the market dynamics and financial trajectory of LOTENSIN HCT becomes essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Overview

The global antihypertensive drugs market is projected to reach approximately USD 34 billion by 2027, growing at a compound annual growth rate (CAGR) of around 4.5% (1). Fixed-dose combinations (FDCs) like LOTENSIN HCT significantly contribute to this growth, driven by their enhanced adherence, simplified regimens, and improved therapeutic outcomes.

LOTENSIN HCT’s primary indications—management of hypertension and edema—align with the increasing prevalence of cardiovascular diseases globally. The World Health Organization (WHO) estimates that hypertension affects over 1.13 billion people worldwide, with significant regional variations influenced by ethnicity, lifestyle, and healthcare infrastructure (2). The expanding hypertensive population directly correlates to increased demand for effective antihypertensive therapies, including combination medications like LOTENSIN HCT.

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Key Market Drivers

1. Rising Prevalence of Hypertension

The global rise in hypertension cases, especially in low- and middle-income countries (LMICs), fuels demand. Urbanization, sedentary lifestyles, and dietary shifts contribute to this trend, creating a sustained need for efficacious antihypertensive solutions (3).

2. Preference for Fixed-Dose Combinations

FDCs improve patient adherence by reducing pill burden, leading to better blood pressure control and decreased complications. Regulatory agencies, such as the FDA and EMA, encourage FDC approval, further promoting their use. LOTENSIN HCT, as a well-established FDC, benefits from this trend.

3. Patent Expiry and Generic Competition

The expiration of patents for many pivotal antihypertensive agents, including hydrochlorothiazide and triamterene, opens pathways for generic versions, intensifying price competition. The availability of generics like LOTENSIN HCT significantly impacts pricing strategies and market penetration dynamics.

4. Increasing Focus on Value-Based Care

Healthcare systems worldwide emphasize cost-effective therapies with proven efficacy, favoring medications like LOTENSIN HCT that streamline treatment protocols and improve patient outcomes.

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Market Challenges

1. Competitive Landscape

The antihypertensive market is highly saturated with numerous branded and generic options. Major pharmaceutical companies such as Novartis, Eli Lilly, and Teva manufacture competing FDCs, making market share acquisition challenging for LOTENSIN HCT.

2. Regulatory Hurdles and Reimbursement Policies

Navigating differing regulatory landscapes across regions can delay product launches and impact sales. Moreover, reimbursement policies favor cost-effective medications, pressuring prices for established products like LOTENSIN HCT.

3. Patent Litigation and Intellectual Property Issues

Potential patent challenges or litigation can affect market exclusivity, influencing the financial trajectory. Companies must strategize around patent protections and market entries.

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Financial Trajectory Analysis

1. Revenue Streams and Market Share

Given its longstanding clinical utility, LOTENSIN HCT enjoys steady demand in mature markets such as North America and Europe. In emerging markets, growth is driven by increasing hypertension awareness and expanding healthcare infrastructure. The drug's revenue is projected to grow modestly at a CAGR of around 2-3% over the next five years, reflective of saturation in developed markets and expansion in LMICs (4).

2. Pricing Dynamics

The entry of generic versions reduces average selling prices (ASPs). However, strategic price positioning by manufacturers, aimed at maintaining margins while remaining competitive, influences overall revenue. In high-income regions, premium pricing persists for branded formulations, bolstered by physician loyalty and brand recognition.

3. R&D Investment and Pipeline Development

While LOTENSIN HCT’s patent status limits future proprietary R&D related to the drug itself, costs associated with manufacturing, regulatory compliance, and marketing persist. Focus shifts to expanding indications, such as combination therapy for resistant hypertension or renal protection, which can enhance financial sustainability.

4. Regulatory and Market Expansion Opportunities

Regulatory approvals in emerging markets can unlock vast revenue streams. For example, gaining approval in populous countries like India and China could contribute significantly, given their large hypertensive populations. Strategic partnerships with local companies might accelerate market entry.

5. Cost Structure and Profitability

Margins are influenced by raw material costs, especially for generics, manufacturing efficiencies, and regulatory compliance expenses. A typical gross margin for generic antihypertensive FDCs ranges between 40-60%, with net margins affected by licensing, distribution, and marketing costs.

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Future Outlook and Strategic Implications

The financial journey of LOTENSIN HCT hinges on several factors:

• Market Penetration: Expansion into emerging markets with substantial hypertensive populations offers growth opportunities. Tailored pricing and local manufacturing could improve competitiveness.

• Product Differentiation: Developing extended-release formulations or fixed-dose regimens with additional benefits may appeal to clinicians and patients, supporting premium pricing.

• Regulatory Strategy: Navigating global regulatory pathways efficiently reduces time-to-market and bolsters revenue streams.

• Lifecycle Management: Collaborations, licensing agreements, and potential new formulations or combination partners can maximize product lifecycle value.

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Conclusion

LOTENSIN HCT’s market dynamics are shaped by global hypertension trends, patent and generic competition, regulatory environments, and evolving healthcare delivery models. While mature markets offer stability, growth potential exists primarily through expansion in emerging economies. Financial trajectory projections suggest moderate growth driven by increased adoption as a cost-effective, well-established antihypertensive agent. Strategic positioning within these dynamics will be critical for stakeholders aiming to optimize profitability and market share.

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Key Takeaways

• The global rise in hypertension sustains demand for combination antihypertensive drugs like LOTENSIN HCT.
• Market growth hinges on expanding into emerging economies, leveraging generic competition, and regulatory approvals.
• Price erosion due to generics challenges margins; differentiation and lifecycle management are vital.
• Adoption in LMICs represents a significant growth area, supported by healthcare infrastructure development.
• Strategic collaborations and product innovations will shape future financial performance.

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FAQs

1. How does patent expiration impact LOTENSIN HCT’s market share?
Patent expirations open markets for generic competitors, leading to price declines but also increasing accessibility. This typically results in decreased revenue per unit but can expand overall market share if the product gains broader acceptance.

2. Are there regulatory challenges in expanding LOTENSIN HCT to emerging markets?
Yes. Each country has unique regulatory frameworks requiring localized approval procedures, which can delay market entry but also offer strategic opportunities if navigated efficiently.

3. What is the competitive landscape for LOTENSIN HCT in developed markets?
Highly saturated, with numerous branded and generic FDCs vying for market share. Differentiation relies on price, physician preference, and formulary inclusion.

4. How might future R&D influence LOTENSIN HCT’s profitability?
While direct R&D may be limited post-patent, developing new formulations or combination therapies can enhance value and extend lifecycle, positively impacting profitability.

5. What role does healthcare policy play in the financial trajectory of LOTENSIN HCT?
Policies favoring cost-effective treatments and adherence programs support growth. Reimbursement frameworks and pricing negotiations heavily influence revenue and market access.

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References

1. MarketWatch. "Antihypertensive Drugs Market Size, Share & Trends Analysis." 2022.
2. World Health Organization. "Hypertension Fact Sheet." 2021.
3. Global Health Data Exchange. "Hypertension Prevalence Data." 2022.
4. IQVIA. "The Global Use of Medicines in 2022."