Hydrochlorothiazide; irbesartan - Generic Drug Details

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

Hydrochlorothiazide; irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Pharmobedient, Prinston Inc, Sandoz, Teva, Unichem, and Watson Labs Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for hydrochlorothiazide; irbesartan

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	16
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	16
DailyMed Link:	hydrochlorothiazide; irbesartan at DailyMed

Recent Clinical Trials for hydrochlorothiazide; irbesartan

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

Sponsor	Phase
Shanghai Jiao Tong University School of Medicine	NA
Vital Strategies	NA
Damanhour University	N/A

See all hydrochlorothiazide; irbesartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN

Applicant	Application No.	Strength	Dosage Form
		12.5MG;300MG	TABLET;ORAL
		12.5MG;150MG	TABLET;ORAL
		12.5MG;300MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for hydrochlorothiazide; irbesartan

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; irbesartan

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; IRBESARTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVALIDE	Tablets	hydrochlorothiazide; irbesartan	300 mg/25 mg	020758	1	2006-06-06
AVALIDE	Tablets	hydrochlorothiazide; irbesartan	150 mg/12.5 mg and 300 mg/12.5 mg	020758	1	2004-11-10

US Patents and Regulatory Information for hydrochlorothiazide; irbesartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203630-001	Feb 22, 2013	AB	RX	No	No
Aurobindo Pharma Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203630-003	Mar 31, 2016	AB	RX	No	No
Lupin Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	201524-002	Feb 27, 2013	AB	RX	No	No
Atlas Pharms Llc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203036-002	Jan 15, 2016		DISCN	No	No
Macleods Pharms Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	202414-002	Sep 27, 2012	AB	RX	No	No

Expired US Patents for hydrochlorothiazide; irbesartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	5,994,348*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	5,994,348*PED

EU/EMA Drug Approvals for hydrochlorothiazide; irbesartan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
sanofi-aventis groupe	Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)	irbesartan, hydrochlorothiazide	EMEA/H/C/000783Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	2007-01-18
Sanofi Winthrop Industrie	Karvezide	irbesartan, hydrochlorothiazide	EMEA/H/C/000221Treatment of essential hypertension.This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	1998-10-16
Sanofi Winthrop Industrie	CoAprovel	irbesartan, hydrochlorothiazide	EMEA/H/C/000222Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	1998-10-14
Krka, d.d., Novo mesto	Ifirmacombi	irbesartan, hydrochlorothiazide	EMEA/H/C/002302Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	yes	no	no	2011-03-04
Teva B.V.	Irbesartan/Hydrochlorothiazide Teva	irbesartan, hydrochlorothiazide	EMEA/H/C/001112Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	yes	no	no	2009-11-26

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Irbesartan

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape exhibits significant growth and evolution driven by an aging population, rising prevalence of hypertension, and innovation in antihypertensive therapies. Among these therapies, Hydrochlorothiazide (HCTZ) and Irbesartan occupy notable positions within the antihypertensive segment. Understanding their market dynamics and the financial trajectory involves analyzing regulatory environments, patent landscapes, competitive forces, and clinical utilization trends. This report provides an in-depth analysis of these factors, crucial for industry stakeholders and investors aiming to navigate this therapeutic space.

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Market Overview and Regulatory Context

Hydrochlorothiazide, a thiazide diuretic introduced over six decades ago, remains a foundational antihypertensive agent. Despite its generic status, HCTZ continues to be widely prescribed due to its cost-effectiveness, efficacy, and extensive clinical evidence supporting its use.

Irbesartan, an angiotensin II receptor blocker (ARB), was approved in the early 2000s and represents a newer class with a more targeted mechanism. It commands premium pricing, initially protected by patents, but has since faced generic competition. The transition from innovative to generic market affects both drugs' revenue streams and market dynamics considerably.

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Market Dynamics

1. Therapeutic Demand and Clinical Guidelines

Hypertension remains a global health concern, affecting over 1.28 billion adults worldwide (WHO, 2021). Both HCTZ and Irbesartan are integral components of treatment regimens aligned with clinical guidelines from organizations like the American College of Cardiology and the European Society of Cardiology. The choice between these agents hinges on patient-specific factors, with HCTZ often favored for its affordability and Irbesartan for patients intolerant to diuretics or with comorbid conditions such as diabetes or chronic kidney disease.

2. Patent Expiry and Generic Competition

Irbesartan’s patent protection expired circa 2017, leading to numerous generic versions entering the market. This has precipitated a sharp decline in its branded sales but increased accessibility, thereby expanding utilization.

Conversely, HCTZ's patent expired in 1982, and it has long been available generically. Nevertheless, branded versions like Microzide continue to generate sales through brand loyalty and patent extensions on specific formulations.

3. Pricing and Reimbursement Dynamics

The shift to generics has substantially lowered drug prices. For HCTZ, the median price has reduced by approximately 80% over the last decade (IMS Health, 2019). Similarly, Irbesartan faced substantial price erosion post-patent expiry. Reimbursement policies, especially in developed markets, favor cost-effective therapies, which benefits generics.

4. Market Penetration and Geographic Variance

Developed markets like the US, Europe, and Japan dominate the usage of both drugs, driven by adherence to clinical guidelines and healthcare infrastructure. Emerging markets—China, India, Brazil—are witnessing rapid growth due to increasing hypertension prevalence and expanding healthcare coverage, positioning generics prominently.

5. Competitive Landscape

The market features several pharmaceutical players. Major manufacturers of Irbesartan include Sanofi, Teva, and Mylan. For HCTZ, numerous companies produce generic formulations, resulting in intensified price competition and margin compression.

6. Innovation and Future Therapeutics

While HCTZ remains a cornerstone, new antihypertensives such as combination therapies and novel ARBs are gaining traction. The development of fixed-dose combinations (FDCs) involving HCTZ—e.g., HCTZ with losartan—are expanding market opportunities, particularly in subsequent years.

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Financial Trajectory Analysis

1. Revenue Trends

Historically, Irbesartan’s sales peaked (~$1.3 billion globally in 2014) before patent expiry precipitated a decline (~$200 million in 2021), reflecting the impact of generic competition. In contrast, HCTZ’s absolute sales are more stable in the aggregate but have exhibited declining trends, especially in markets transitioning to newer therapies or combination formulations.

2. Pricing Trends

The cost of branded Irbesartan peaked pre-patent expiry; subsequent generic entries caused prices to fall by over 90%. HCTZ’s prices have remained low; however, branded formulations sustain some premium through formulations or extended-release variants.

3. Profitability Considerations

For manufacturers, profit margins on branded Irbesartan faded as generic competition intensified, necessitating diversification or focus on niche markets. Conversely, generics manufacturers capitalize on volume, compensating for decreased margins. HCTZ’s low cost and high volume sustain steady revenue streams for manufacturers with efficient production.

4. Market Forecast (2023–2030)

• Hydrochlorothiazide: Expected to maintain stable demand in low- and middle-income countries, with residual markets in developed nations. The rise of combination therapies may marginally affect monopreparations.

• Irbesartan: Market revenues are declining but could stabilize for a subset of patients requiring ARB therapy. Growth prospects lie in combination FDCs, personalized medicine, and specialty formulations.

5. Emerging Trends Impacting Financial Trajectory

• Biosimilars and Generics: Accelerate price erosion but expand accessible treatment options.
• Digital and Remote Monitoring: Improve adherence, potentially influencing prescription patterns.
• Market Consolidation: Increased mergers and acquisitions in generics can lead to pricing power shifts.

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Conclusion

The long-term financial outlook for Hydrochlorothiazide remains relatively stable, buoyed by its status as a cost-effective first-line therapy globally. Meanwhile, Irbesartan’s revenue trajectory is characterized by a steep decline post-patent expiry, although niche markets and combination formulations offer some growth potential. Overall, the antihypertensive segment is transitioning toward multi-agent combinations and personalized therapies, shaping future market and financial landscapes.

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Key Takeaways

• Hydrochlorothiazide sustains demand through its affordability and broad clinical acceptance, ensuring a stable, albeit slowly declining, revenue stream.
• Irbesartan experienced peak revenues pre-patent expiry; its future depends on innovation in combination therapies and niche markets.
• Generic Competition has radically reshaped pricing, profitability, and market access, favoring high-volume, low-margin strategies.
• Emerging Markets present growth opportunities driven by increasing hypertension prevalence and expanding healthcare infrastructure.
• Market Evolution toward fixed-dose combinations and personalized therapies will influence both drugs’ financial trajectories over the next decade.

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FAQs

1. How does patent expiration affect Hydrochlorothiazide and Irbesartan market dynamics?
Patent expiration introduces generic competition, significantly reducing prices. HCTZ, long past patent protection, remains low-cost with stable demand. Irbesartan's patent expiry in 2017 led to a dramatic decline in branded sales but expanded accessibility through generics.

2. What factors influence the choice between Hydrochlorothiazide and Irbesartan in clinical practice?
Clinicians consider patient comorbidities, risk profiles, contraindications, and cost. HCTZ is often first-line due to affordability, whereas Irbesartan favors patients needing ARB-specific benefits or who are intolerant to diuretics.

3. What is the outlook for combination therapies involving these drugs?
FDCs combining HCTZ with other antihypertensives, including Irbesartan, are expanding market share due to improved adherence and clinical efficacy, presenting growth opportunities for both agents.

4. How do emerging markets influence the future demand for these drugs?
Growing hypertension prevalence and expanding healthcare access in emerging economies drive increased demand, especially for low-cost generics like HCTZ and affordable ARB options such as Irbesartan.

5. Are there any notable regulatory or patent developments impacting these drugs?
Patent expiries have opened markets for generics, intensifying competition. Regulatory approvals for biosimilars and new formulations may alter market share and profitability over time.

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References

[1] World Health Organization. (2021). Hypertension.
[2] IMS Health. (2019). Global Pharmaceutical Pricing Trends.
[3] FDA. (2002). Irbesartan New Drug Application Data.
[4] European Medicines Agency. (2017). Irbesartan Market Authorization.