Hydrochlorothiazide; losartan potassium - Generic Drug Details

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

Hydrochlorothiazide; losartan potassium is the generic ingredient in two branded drugs marketed by Organon, Alembic Pharms Ltd, Apotex, Aurobindo Pharma, Chartwell Rx, Granules, Hikma, Ipca Labs Ltd, Jubilant Cadista, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms, Torrent Pharms, Unichem, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

Summary for hydrochlorothiazide; losartan potassium

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Finished Product Suppliers / Packagers:	28
Clinical Trials:	15
DailyMed Link:	hydrochlorothiazide; losartan potassium at DailyMed

Recent Clinical Trials for hydrochlorothiazide; losartan potassium

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	Phase 4
Kyushu University	Phase 3
Agenzia Italiana del Farmaco	Phase 4

See all hydrochlorothiazide; losartan potassium clinical trials

Pharmacology for hydrochlorothiazide; losartan potassium

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; losartan potassium

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

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	100 mg/12.5 mg	020387	1	2006-04-04
HYZAAR	Tablets	hydrochlorothiazide; losartan potassium	50 mg/12.5 mg and 100 mg/25 mg	020387	1	2004-05-24

US Patents and Regulatory Information for hydrochlorothiazide; losartan potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	200180-003	Jan 12, 2011		DISCN	No	No
Alembic Pharms Ltd	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	091617-003	Feb 17, 2012	AB	RX	No	No
Ipca Labs Ltd	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	201682-002	Mar 1, 2013		DISCN	No	No
Unichem	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; losartan potassium	TABLET;ORAL	204832-001	Jul 21, 2017	AB	RX	No	No

Expired US Patents for hydrochlorothiazide; losartan potassium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Losartan Potassium

Last updated: July 31, 2025

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Introduction

Hydrochlorothiazide and Losartan Potassium stand as pivotal pharmaceuticals in the management of hypertension and related cardiovascular conditions. Their combined use or individual application defines a substantial segment in the global antihypertensive market, which is driven by evolving clinical guidelines, patent landscapes, manufacturing innovations, and emerging healthcare needs. This analysis delineates key market forces influencing these drugs' trajectories, providing strategic insight into their current and future financial prospects.

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Market Overview

Hydrochlorothiazide (HCTZ), a thiazide diuretic, has been a mainstay in hypertension therapy for decades. Its affordability and proven efficacy have entrenched it as a first-line treatment in numerous clinical guidelines globally[1]. Losartan Potassium, an angiotensin receptor blocker (ARB), entered the market in the late 1990s, offering an alternative for patients intolerant to ACE inhibitors, with strong safety and tolerability profiles[2].

Combined formulations of hydrochlorothiazide and losartan (e.g., Hyzaar) capitalize on synergistic effects, representing significant revenue streams for patent holders and generic manufacturers alike[3]. The landscape is characterized by a mature therapeutic market transitioning towards generic dominance, with substantial implications for pricing, innovation, and market share.

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Market Drivers

1. Rising Prevalence of Hypertension and Cardiovascular Diseases

The global burden of hypertension is escalating, with approximately 1.28 billion adults affected worldwide[4]. Increasing incidence in aging populations and lifestyle-related risk factors propel demand for antihypertensive medications, including hydrochlorothiazide and losartan. This trend forecasts sustained volume growth, particularly in emerging markets with expanding healthcare infrastructure.

2. Cost-Effectiveness and Generic Competition

Hydrochlorothiazide's status as a low-cost medication since patent expiry in the early 2000s has cemented its position in public health initiatives, especially in resource-limited settings. Similarly, losartan’s patent expiration in the U.S. in 2010 facilitated a flood of generic alternatives, intensifying price competition and expanding access[5].

Generic proliferation decreases drug prices substantially, influencing overall market revenues. Nonetheless, this transition creates lucrative opportunities for manufacturers that streamline production and distribution in emerging markets.

3. Clinical Guideline Evolution

Recent guidelines favor combination therapy approaches—often including hydrochlorothiazide and losartan—for optimal blood pressure control[6]. The approval of fixed-dose combinations (FDCs) simplifies regimens, improves adherence, and boosts sales volumes. Regulatory endorsements for these combinations reinforce market stability.

4. Innovation and Biosimilars

While no biosimilars exist for hydrochlorothiazide or losartan due to their small-molecule nature, ongoing research into improved formulations, extended-release variants, and novel ARBs can influence the competitive landscape, potentially generating incremental revenue streams.

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Market Barriers and Challenges

1. Patent Expirations and Generic Encroachment

Patent losses for losartan and hydrochlorothiazide have led to widespread generic entry, compressing profit margins for branded manufacturers. Market saturation limits growth potential and necessitates diversification into new therapeutic areas or delivery methods.

2. Safety and Efficacy Concerns

Electrolyte imbalance risks with hydrochlorothiazide and potential side effects of losartan, such as hyperkalemia or renal impairment, have prompted reevaluation by clinicians. Stringent regulatory scrutiny and post-marketing surveillance influence prescribing practices and market dynamics.

3. Regulatory and Reimbursement Variability

Regional disparities in drug approval processes and reimbursement policies impact market penetration. Countries with evolving healthcare systems may favor cost-effective generics over branded formulations, affecting revenue streams.

4. Competition from Newer Agents

Emergence of novel antihypertensive agents, such as neprilysin inhibitors and direct renin inhibitors, challenge the dominance of hydrochlorothiazide and losartan, particularly when they demonstrate superior efficacy or safety profiles[7].

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Financial Trajectory and Market Forecasts

Current Market Size

As of 2023, the global antihypertensive drugs market exceeds USD 20 billion, with hydrochlorothiazide and losartan constituting a significant proportion—estimated at approximately USD 4 billion collectively, factoring in generics and branded formulations[8].

Growth Projections

Analysts project a compound annual growth rate (CAGR) of 3-5% for this segment over the next five years, driven largely by the expanding global hypertensive population and increased adoption of combination therapies[9].

Regional Market Insights

• North America: Dominates due to high prevalence, advanced healthcare infrastructure, and extensive generic penetration.
• Europe: Stable growth, with a focus on biosimilars and novel combinations.
• Asia-Pacific: Fastest-growing due to large patient base, increasing healthcare spending, and expanding drug registration activities.

Revenue Outlook

Manufacturers with a diversified portfolio, including fixed-dose combinations and emerging markets, are poised to capitalize on the volume growth. Price erosion from generics necessitates operational efficiencies to sustain profit margins.

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Regulatory and Patent Landscapes

Patent expiries have catalyzed a wave of generic manufacturing, significantly reducing drug prices. Notable patent timelines include losartan (extinct in the U.S. since 2010) and hydrochlorothiazide, which lost patent protection much earlier. Remaining patent protections on combination formulations or formulations with extended-release profiles can sustain branded revenues temporarily.

Regulatory agencies continually assess the safety profiles of these drugs, influencing labeling updates and prescribing restrictions. Future regulatory developments may favor innovative formulations or delivery systems that could reestablish premium pricing.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on lifecycle management through new formulations, combination therapies, and entering markets with unmet needs.
• Investors: Watch patent cliffs, regulatory shifts, and regional market expansions for risk mitigation and opportunity identification.
• Healthcare Systems: Emphasize universal access through cost-effective generics without compromising quality, balancing affordability with safety.

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Key Takeaways

• The market for hydrochlorothiazide and losartan potassium remains robust, primarily fueled by the global rise in hypertension prevalence.
• Patent expirations have transitioned the market toward generic dominance, compressing margins but expanding access.
• Growth is increasingly driven by combination therapies aligned with evolving clinical guidelines, alongside regional expansion into Asia-Pacific and other emerging markets.
• Innovation remains essential; firms investing in new formulations and delivery systems can circumvent intense price competition.
• Regulatory landscape dynamics, including safety assessments and reimbursement policies, significantly influence market trajectory and revenue potential.

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FAQs

1. How do patent expirations affect the market for hydrochlorothiazide and losartan?
Patent expirations enable generic manufacturers to produce lower-cost versions, increasing market competition, reducing prices, and decreasing revenues for branded counterparts. This shift enhances patient access but challenges brand loyalty and profit margins.

2. What role do fixed-dose combinations play in the market?
FDCs improve patient compliance, streamline therapy, and are favored by clinical guidelines, thus driving their adoption and sales growth despite generic price pressures.

3. Are there emerging alternatives to hydrochlorothiazide and losartan in hypertension management?
Yes. Agents like neprilysin inhibitors, direct renin inhibitors, and novel ARBs are in development or early-stage approval, which could redefine the antihypertensive treatment landscape.

4. How does regional variation influence market dynamics?
High-income regions like North America and Europe tend toward branded formulations and innovative therapies, while emerging markets rely heavily on generics, driven by price sensitivity and healthcare infrastructure evolution.

5. What is the outlook for pharmaceutical companies manufacturing these drugs?
While current revenues are declining due to generics, companies can extend product life cycles through reformulations, entering emerging markets, and investing in adjunct therapies or combination products.

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References

[1] World Health Organization. "Hypertension prevalence."
[2] U.S. Food and Drug Administration. "Losartan label."
[3] MarketWatch. "Revenue from combined hydrochlorothiazide and losartan formulations."
[4] WHO. "Global hypertension report."
[5] FDA. "Losartan patent status."
[6] American Heart Association. "2017 Guideline for high blood pressure management."
[7] Lancet. "Emerging antihypertensive therapies."
[8] Grand View Research. "Antihypertensive drugs market size & trends."
[9] Frost & Sullivan. "Healthcare market forecast 2023–2028."

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In conclusion, hydrochlorothiazide and losartan potassium will continue to serve as essential components in hypertension management, with their market trajectory shaped by patent landscapes, clinical guideline shifts, and regional dynamics. Strategic positioning in innovation, production efficiency, and emerging markets will determine stakeholder success in this mature yet evolving sector.