HYZAAR Drug Patent Profile

Which patents cover Hyzaar, and what generic alternatives are available?

Hyzaar is a drug marketed by Organon and is included in one NDA.

The generic ingredient in HYZAAR is hydrochlorothiazide; losartan potassium. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; losartan potassium profile page.

Summary for HYZAAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	16
Drug Prices:	Drug price information for HYZAAR
Drug Sales Revenues:	Drug sales revenues for HYZAAR
What excipients (inactive ingredients) are in HYZAAR?	HYZAAR excipients list
DailyMed Link:	HYZAAR at DailyMed

See drug prices for HYZAAR

See drug sales revenues for HYZAAR

Recent Clinical Trials for HYZAAR

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

Sponsor	Phase
EMS	Phase 3
Centre Hospitalier Universitaire de Saint Etienne	Phase 4
Azidus Brasil	Phase 1

See all HYZAAR clinical trials

Pharmacology for HYZAAR

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

Paragraph IV (Patent) Challenges for HYZAAR

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 HYZAAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005	AB	RX	Yes	No
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998	AB	RX	Yes	No

Expired US Patents for HYZAAR

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
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-003	Oct 20, 2005
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-001	Apr 28, 1995
Organon	HYZAAR	hydrochlorothiazide; losartan potassium	TABLET;ORAL	020387-002	Nov 10, 1998

International Patents for HYZAAR

See the table below for patents covering HYZAAR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	19875033
Norway	177265
Japan	H03501020
World Intellectual Property Organization (WIPO)	9200067
Denmark	359687
Hungary	218460	Eljárás új, szubsztituált imidazolszármazékok, és hatóanyagként e vegyületeket tartalmazó gyógyszerkészítmények előállítására (PROCESS FOR PREPARING SUBSTITUDED IMIDAZOLE DERIVATIVES AND PHARMACEUTICAL PREPARATIONS CONTAINING THEM)
South Africa	8705052

Supplementary Protection Certificates for HYZAAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0733366	SZ 25/1998	Austria		PRODUCT NAME: LOSARTAN-KALIUM UND HYDROCHLOROTHIAZID
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
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0733366	98C0030	Belgium		PRODUCT NAME: KALII LOSARTAN, HYDROCHLOROTHIAZIDUM; NAT. REGISTRATION NO/DATE: 922 IS 174 F 3 19980223; FIRST REGISTRATION: FR 338 520.7 19950215

Market Dynamics and Financial Trajectory of HYZAAR

Last updated: July 29, 2025

Introduction

HYZAAR, a combination of valsartan and hydrochlorothiazide, has carved a significant niche within the antihypertensive medication market. Approved by the U.S. Food and Drug Administration (FDA) in 2007, the drug offers a dual mechanism to manage hypertension and reduce cardiovascular risk. This analysis explores the evolving market landscape, regulatory influences, competitive dynamics, and the financial trajectory influencing HYZAAR’s commercial performance.

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Market Overview and Demand Drivers

The global antihypertensive market is a cornerstone in cardiovascular disease management, driven primarily by the rising prevalence of hypertension worldwide. According to the World Health Organization (WHO), over 1.2 billion people globally suffer from hypertension, with projections indicating a steady increase, especially in low- and middle-income countries due to urbanization, aging populations, and lifestyle changes [1].

HYZAAR's pharmaceutical profile—combining an angiotensin receptor blocker with a diuretic—addresses the need for effective, combination therapy in patients inadequately managed with monotherapy. The drug's efficacy in reducing blood pressure and cardiovascular events consolidates its position within treatment guidelines, such as those from the American College of Cardiology (ACC) and the American Heart Association (AHA).

Furthermore, increasing awareness about medication adherence and cost-effectiveness favors fixed-dose combinations like HYZAAR, which improve compliance and reduce pill burden. The rising healthcare expenditure and policies favoring the use of generic and combination drugs bolster the drug’s adoption.

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Regulatory and Patent Landscape

HYZAAR initially benefited from patent exclusivity, ensuring market protection and a period of limited competition. However, key patents on formulations and manufacturing processes expired over the last decade, allowing generic manufacturers to introduce equivalent products, intensifying price competition.

Rumors of patent cliffs in jurisdictions such as the U.S. and Europe have prompted the manufacturer, initially marketed by Sanofi and later contracted to other firms following Merck’s acquisition of the originating rights, to develop next-generation formulations and combination therapies. The expiration of patents has led to a significant decline in the drug’s average selling price (ASP), pressuring revenue streams.

Regulatory bodies have also issued warnings and imposed restrictions following concerns about potential adverse effects and the introduction of biosimilar competition, somewhat dampening market enthusiasm. Nonetheless, regulatory approvals of similar combination drugs using alternative ARBs and diuretics continue to fragment the market share.

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Competitive Dynamics

HYZAAR faces stiff competition from both branded and generic antihypertensives. Generic versions surged onto the market post-patent expiration, substantially eroding the original drug’s market share and profitability.

Key competitors include fixed-dose combinations such as:

• Olmesartan/Hydrochlorothiazide
• Amlodipine/Valsartan
• Losartan/Hydrochlorothiazide

These alternatives often feature improved tolerability profiles and differing mechanisms, appealing to physicians seeking tailored patient management. The increasing prominence of novel therapeutics targeting resistant hypertension and patients with complex comorbidities further complicates HYZAAR’s competitive environment.

Additionally, the advent of personalized medicine and digital health monitoring influences treatment choices, emphasizing drugs with proven efficacy and safety profiles, areas where HYZAAR maintains an advantage due to extensive clinical data.

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Market Penetration and Geographic Trends

North America remains the largest market for antihypertensive combination drugs, accounting for approximately 45% of sales as of 2022, driven by high prevalence, advanced healthcare infrastructure, and aggressive marketing strategies. Europe follows, with similar but slightly slower growth rates, hampered by pricing pressures and reimbursement constraints.

Emerging markets in Asia-Pacific, Latin America, and Africa present substantial growth opportunities, fueled by increasing hypertension prevalence, expanding healthcare access, and evolving prescribing practices. However, price sensitivity and regulatory hurdles pose challenges for market entry and growth.

HyZAAR’s sales trends mirror these regional dynamics. Initial rapid uptake in the U.S. benefited from early market exclusivity; subsequent erosion of market share due to generics has led to a plateau in revenue growth. Conversely, growth in emerging markets remains nascent but promising, contingent on local regulatory approvals and market penetration strategies.

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Financial Trajectory and Revenue Outlook

HYZAAR's revenue trajectory has experienced notable shifts:

• Pre-Patent Expiry (2007–2017): Revenue experienced robust growth, supported by patent protection, widespread clinician adoption, and favorable pricing strategies. Peak sales exceeded several billion dollars annually.

• Post-Patent Expiry (2018 onward): Introduction of generics caused sharp declines, with revenues falling by approximately 70% over five years. Pricing pressure intensified, with discounts and rebates eroding profit margins.

• Market Diversification and Lifecycle Management: To sustain revenues, manufacturers introduced new formulations, fixed-dose combination variants employing different ARBs, and secured approvals in emerging markets.

• Impact of Regulatory and Legal Challenges: Ongoing litigation linked to patent disputes and safety concerns has also influenced financial performance, sometimes causing volatility in income streams.

Projections indicate that, absent strategic repositioning or pipeline innovations, HYZAAR’s sales will stabilize or decline marginally in mature markets. Conversely, potential growth arises from expanding indications, increased use of fixed-dose combinations in emerging markets, and the introduction of biosimilars.

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Strategic Considerations and Future Outlook

Given the expiration of patents and intense price competition, the future of HYZAAR hinges on:

• Pipeline Innovation: Development of next-generation antihypertensives with improved side effect profiles, longer durations of action, and personalized treatment options.

• Market Expansion: Strengthening presence in underserved regions and leveraging local partnerships to penetrate emerging markets.

• Lifecycle Management: Portfolio diversification with newer fixed-dose combinations, combination pills tailored for resistant hypertension, and formulations with improved adherence features.

• Regulatory Engagement: Active pursuit of expanded indications and biosimilar development to mitigate revenue erosion.

• Cost Optimization: Reducing manufacturing costs and leveraging digital health initiatives to improve prescribing efficiency.

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Key Takeaways

• Growing Global Burden of Hypertension sustains demand for combination therapies like HYZAAR, though market share faces pressure from generic competition.

• Patent Expirations and Market Saturation significantly impacted revenue, necessitating strategic innovation and diversification.

• Regional Market Dynamics position North America as the primary revenue driver, with emerging markets offering long-term growth prospects contingent on regulatory and economic factors.

• Competitive Landscape is consolidating with biosimilar entries and newer clinical guidelines emphasizing personalized and resistant hypertension management.

• Strategic Adaptation through product evolution, pipeline development, and geographic expansion is crucial for sustaining financial performance.

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FAQs

1. How has patent expiration affected HYZAAR’s market share?
Patent expiry led to the entry of generic competitors, causing a substantial decline in HYZAAR’s market share and revenues, with estimates indicating a 70% revenue reduction over five years.

2. What are the primary competitors to HYZAAR?
HYZAAR faces competition from other fixed-dose antihypertensive combinations such as olmesartan/hydrochlorothiazide, amlodipine/valsartan, and losartan/hydrochlorothiazide, as well as emerging novel therapies for resistant hypertension.

3. What strategic moves can manufacturers employ to sustain HYZAAR’s market presence?
Innovating with new formulations, expanding indications, entering emerging markets, and developing biosimilars are key strategies for maintaining or growing revenues.

4. How do regional healthcare policies influence HYZAAR’s sales?
Stringent reimbursement policies, pricing regulations, and market access frameworks in Europe and North America affect sales, while expanding healthcare coverage in emerging markets offers growth opportunities.

5. What is the outlook for HYZAAR’s future financial performance?
Without new innovations, revenues will likely plateau or decline due to generic competition; however, strategic diversification and market expansion may offset some decline, especially in emerging regions.

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References

[1] World Health Organization. (2021). Hypertension. Retrieved from WHO website.