HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - Generic Drug Details

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

Hydrochlorothiazide; olmesartan medoxomil is the generic ingredient in two branded drugs marketed by Cosette, Accord Hlthcare, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Hangzhou Binjiang, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Natco Pharma Usa, Prinston Inc, Teva Pharms Usa, Torrent, Umedica, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	16
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
DailyMed Link:	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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

Sponsor	Phase
Altasciences Company Inc.	Phase 1
Pharmtechnology LLC	Phase 1
Altasciences Company, Inc.	Phase 1

See all HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

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; OLMESARTAN MEDOXOMIL

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; OLMESARTAN MEDOXOMIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	20 mg/12.5 mg	021532	1	2007-05-11
BENICAR HCT	Tablets	hydrochlorothiazide; olmesartan medoxomil	40 mg/12.5 mg and 40 mg/25 mg	021532	1	2007-02-15

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	209199-002	Jul 25, 2025	AB	RX	No	No
Teva Pharms Usa	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200532-002	Apr 24, 2017		DISCN	No	No
Natco Pharma Usa	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	078827-003	Oct 26, 2016		DISCN	No	No
Hangzhou Binjiang	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	214427-002	Aug 20, 2025	AB	RX	No	No
Msn	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	217398-002	Sep 26, 2025	AB	RX	No	No
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003	AB	RX	Yes	No
Natco Pharma Usa	OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	078827-001	Oct 26, 2016		DISCN	No	No

Expired US Patents for HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-005	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-003	Jun 5, 2003
Cosette	BENICAR HCT	hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	021532-002	Jun 5, 2003

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Olmesartan Medoxomil

Last updated: July 30, 2025

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Introduction

The global pharmaceutical landscape exhibits dynamic shifts driven by evolving healthcare needs, regulatory frameworks, and technological advancements. Among antihypertensive agents, hydrochlorothiazide (HCTZ) and olmesartan medoxomil stand out due to their widespread usage in managing hypertension and related cardiovascular conditions. Analyzing their market trajectories involves understanding their pharmacological profiles, prescribing trends, competitive landscape, and regulatory influences shaping their commercial prospects.

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Pharmacological Profile and Market Position

Hydrochlorothiazide (HCTZ):
HCTZ is a thiazide diuretic widely utilized as a first-line therapy in hypertension management. Its affordability, well-established efficacy, and long history of use have cemented its position in clinical practice. Despite newer agents, HCTZ remains a cornerstone due to extensive clinical data and low cost, especially in generic form.

Olmesartan Medoxomil:
Olmesartan, an angiotensin II receptor blocker (ARB), gained popularity as an alternative for patients intolerant to other antihypertensives. Its unique profile includes potent antihypertensive effects and a favorable side-effect profile, positioning it as a preferred choice in moderate-to-severe hypertension management.

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Market Dynamics

1. Regulatory Influences and Patent Landscapes

The patent expiration cycle significantly impacts market dynamics.

• Hydrochlorothiazide: Patents expired decades ago, leading to a proliferation of generics and intense price competition [1]. This widespread generic availability sustains strong volume sales but stagnates profit margins for brand-name manufacturers.
• Olmesartan Medoxomil: Patents for olmesartan expired around 2019, triggering a surge in generic entries. The disruption prompts pharmaceutical companies to innovate and seek new formulations or combination therapies to preserve revenue streams.

2. Competitive Landscape

• Hydrochlorothiazide: Dominant in low-cost generic segments, facing competition from other diuretics and fixed-dose combinations. Market growth is limited, primarily driven by generic consumption expansion in emerging markets.
• Olmesartan Medoxomil: Faces competition from other ARBs like losartan, valsartan, and newer agents such as azilsartan. The competition has intensified as generics become more available, constraining pricing power but diversifying product portfolios with combination therapies.

3. Therapeutic Guidelines and Prescribing Trends

Evolving clinical guidelines influence demand.

• The 2017 American College of Cardiology/American Heart Association (ACC/AHA) guidelines emphasize combination therapy for uncontrolled hypertension, often pairing diuretics with ARBs. This has increased demand for fixed-dose combinations, such as hydrochlorothiazide with olmesartan [2].
• A shift toward personalized medicine encourages utilization of ARBs like olmesartan over ACE inhibitors due to lower risk of cough and angioedema, expanding its market share in certain patient populations.

4. Market Penetration in Emerging Markets

Emerging markets, including China, India, and Latin America, offer sizable growth opportunities due to rising hypertension prevalence, increasing healthcare access, and cost-sensitive treatment preferences.

• Hydrochlorothiazide’s affordability ensures sustained demand.
• Olmesartan’s growth hinges on regulatory approvals, pricing strategies, and physician prescribing habits, with increasing adoption noted in urban centers.

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Financial Trajectory

1. Revenue and Profitability Trends

• Hydrochlorothiazide:
  Sales are primarily driven by generics, with margins compressed due to intense price competition. According to IQVIA, hydrochlorothiazide remains among the top prescribed antihypertensives globally, with stable volume sales but limited growth potential.
• Olmesartan Medoxomil:
  Post-patent expiration, revenue declined in mature markets but remains significant where branded formulations or innovative combination products retain value. Pharmaceutical companies are exploring next-generation ARBs and fixed-dose combinations to reinvigorate sales.

2. Market Growth Projections

• The antihypertensive drugs market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-5% over the next five years, driven by aging populations and increasing hypertension prevalence.
• Fixed-dose combinations integrating hydrochlorothiazide and olmesartan are expected to outpace segment growth due to improved patient adherence and clinical efficacy.

3. R&D and Innovation Impact

Investment in developing novel formulations, combination therapies, and biosimilars remains critical. Companies focusing on fixed-dose combinations (FDCs) are poised to capture market share, especially in regions emphasizing compliance and simplification of treatment regimens [3].

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Regulatory and Market Challenges

• Pricing and Reimbursement Policies:
  Governments and insurers are implementing strict pricing controls, impacting profit margins. The shift toward generic utilization pressures manufacturers to innovate or differentiate their products.

• Safety and Efficacy Reassessments:
  New clinical data and post-market surveillance can influence prescribing habits. The withdrawal of certain ARBs or reclassification of safety profiles can alter market dynamics, as seen in earlier controversies surrounding losartan and valsartan [4].

• Patent Strategies and Litigation:
  Companies engaging in patent litigation or seeking exclusivity through orphan designation or unique formulations attempt to safeguard revenues, influencing market boundaries.

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Future Outlook

The future trajectory of hydrochlorothiazide and olmesartan medoxomil is shaped by both market saturation in established regions and growth opportunities in emerging economies. The ongoing evolution toward combination therapies, personalized medicine, and digital health integration fosters an environment favoring innovation and strategic positioning.

Hydrochlorothiazide's low-cost nature ensures baseline demand, but its growth is constrained. Conversely, olmesartan medoxomil, enriched by combination formulations and potential next-generation ARBs, offers avenues for revenue expansion, especially in healthcare systems prioritizing adherence and improved outcomes.

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Key Takeaways

• Market saturation has limited significant growth prospects for hydrochlorothiazide; the focus lies in maintaining volume through cost-effective generic sales and combination therapies.
• Olmesartan medoxomil faces increasing generic competition but remains relevant through formulation innovations and regional market expansion.
• Regulatory dynamics and pricing policies will continue to shape profitability, emphasizing the importance of R&D and strategic patent management.
• Emerging markets represent pivotal growth zones for both agents, driven by rising hypertension prevalence and healthcare system improvements.
• Innovations in fixed-dose combinations that simplify therapy regimens and improve compliance are likely to be key revenue drivers.

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FAQs

Q1: How does patent expiry affect the market dynamics of hydrochlorothiazide and olmesartan medoxomil?
Patent expiration leads to a surge in generic entries, increasing competition, reducing prices, and compressing profit margins. Hydrochlorothiazide’s patents expired long ago, resulting in a saturated generics market, while olmesartan's patent expiry in 2019 caused a recent shift, prompting companies to explore combination therapies to retain market share.

Q2: What are the main drivers for the growth of fixed-dose combinations involving these drugs?
Fixed-dose combinations improve patient adherence, simplify regimens, and enhance therapeutic efficacy. As clinical guidelines favor combination therapy for hypertension, pharmaceutical firms focus on developing FDCs of hydrochlorothiazide with olmesartan to capitalize on this trend.

Q3: Which regions offer the most significant growth opportunities for these antihypertensive agents?
Emerging markets like China, India, and Latin America drive growth due to increasing hypertension prevalence, expanding healthcare access, and cost-sensitive treatment preferences favoring generics and combinations.

Q4: What challenges do manufacturers face in maintaining profitability in this segment?
Intense price competition, regulatory pressures, and the expiration of patents compress margins. Additionally, safety concerns, generic price erosion, and reimbursement policies challenge revenue sustainability.

Q5: How might future innovation influence the market trajectory for hydrochlorothiazide and olmesartan?
Innovation in formulations, such as novel combination therapies, extended-release formulations, or digital health integrations, will be essential for maintaining competitive advantages and opening new revenue streams amid generic price pressures.

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Sources

1. IQVIA. (2022). Global Prescription Drug Market Report.
2. Arnett, D. K., et al. (2017). 2017 ACC/AHA Hypertension Guidelines. Journal of the American College of Cardiology.
3. IMS Health. (2021). Market Trends in Hypertension Management.
4. U.S. FDA. (2018). Post-market safety updates for ARBs.

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This comprehensive analysis targets stakeholders seeking current insights into hydrochlorothiazide and olmesartan medoxomil's market and financial trends, enabling informed strategic decisions in the evolving pharmaceutical environment.