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
Vital Strategies	NA
Shanghai Jiao Tong University School of Medicine	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
		25MG;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
Hisun Pharm Hangzhou	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	207896-001	Oct 14, 2016	AB	RX	No	No
Dr Reddys Labs Ltd	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203500-002	Sep 27, 2012	AB	RX	No	No
Watson Labs Inc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	091539-002	Oct 22, 2012		DISCN	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	020758-001	Sep 30, 1997
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005

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

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Irbesartan

Last updated: February 15, 2026

Hydrochlorothiazide (HCTZ) and irbesartan are hypertension medications with distinct market roles. HCTZ, a thiazide diuretic, remains a widely prescribed first-line treatment. Irbesartan, an angiotensin receptor blocker (ARB), addresses resistant hypertension and diabetic nephropathy.

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Hydrochlorothiazide (HCTZ): Market Size and Trends

Market Overview

• HCTZ holds a dominant position among antihypertensive agents, with an estimated global revenue of approximately $1.2 billion in 2022, representing a CAGR of 3.2% over the previous five years [1].

• Its widespread use stems from efficacy, low cost, and long-term safety profile. Generic formulations account for 85% of prescriptions.

Market Drivers

• Increasing prevalence of hypertension affects demand. The WHO estimates 1.3 billion adults worldwide with high blood pressure in 2020, expected to rise [2].

• Healthcare systems favor low-cost medications; HCTZ's patent expiration in the early 2000s led to low-cost generics accessible in emerging markets.

Market Challenges

• Shift toward combination therapies reduces monotherapy prescriptions.

• Emerging data on metabolic side effects prompts some clinicians to favor other classes like ARBs or ACE inhibitors.

Financial Trajectory

• Revenues projected to grow modestly at 2-3% annually over the next five years, driven by demand in developing regions.

• The market for HCTZ is increasingly saturated; growth hinges on new formulations or combination products.

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Irbesartan: Market Dynamics and Financial Outlook

Market Overview

• Irbesartan generated approximately $650 million globally in 2022, a decline of 5% from the previous year, reflecting patent expiry and generic competition [1].

• It is marketed chiefly by pharmaceutical companies such as Sanofi and expects to face strong competition from other ARBs like losartan and olmesartan.

Market Drivers

• Increasing prevalence of resistant hypertension enhances demand for ARBs like irbesartan.

• Growth in diabetic patient populations requiring renin-angiotensin system (RAS) blockade sustains interest.

• Regulatory approvals for indications such as diabetic nephropathy bolster sales prospects.

Market Challenges

• Patent expiry in 2012 led to the generic market entry, rapidly reducing prices.

• Competition from other ARBs with similar efficacy but lower costs diminishes market share.

• Mandatory adoption of combination therapies incorporating ARBs reduces standalone irbesartan sales.

Financial Trajectory

• Revenue decline is projected to slow, with some stabilization through expanded indications.

• Future growth prospects include biosimilars and combination drug formulations, which may recoup some market share.

• The overall ARB segment is experiencing a CAGR of approximately -3.5% for 2022-2027 due to price erosion and competition [3].

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Comparison and Market Outlook

Parameter	Hydrochlorothiazide	Irbesartan
Global Revenue	~$1.2 billion (2022)	~$650 million (2022)
Market Trend	Stable to moderate growth	Declining, some stabilization
Patent Status	Patent expired (2000s)	Patent expired (2012)
Cost Structure	Low-cost generic dominant	Price erosion post-patent
Future Growth	Modest, driven by emerging markets	Limited, possibly stabilized

Market Opportunities

• HCTZ: Development of fixed-dose combinations, especially with other antihypertensives, to extend lifecycle.

• Irbesartan: Focus on new indications, biosimilar entry, and innovative delivery systems.

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Legal and Regulatory Environment

• Both drugs face patent expirations that influence pricing strategies. HCTZ's generics dominate; no current patent protections.

• IRBs and regulatory agencies, such as the FDA and EMA, continue to monitor safety data, especially post-market.

• Labeling updates based on emerging evidence on metabolic effects influence prescribing trends.

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Key Takeaways

• HCTZ maintains broad use due to low cost and established efficacy, with growth driven mainly by emerging markets.

• Irbesartan's market has contracted due to patent expiry and competition but retains demand in specific clinical niches.

• Market share for both drugs is primarily influenced by patent status, pricing, and evolving clinical practice patterns.

• Innovation in combination therapies and expanded indications may create new revenue streams.

• Regulatory developments and generic competition will continue to impact revenue trajectories.

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FAQs

1. What factors drive the continued use of hydrochlorothiazide?
   Its low cost, long-term safety, and extensive clinical history sustain its widespread prescribing, especially in resource-limited settings.

2. How does patent expiry impact irbesartan's market?
   It facilitates generic entry, creating price competition and reducing revenue for branded versions.

3. Are there any new formulations of hydrochlorothiazide?
   Yes, fixed-dose combinations with other antihypertensives aim to improve adherence and extend lifecycle.

4. Can irbesartan regain market share?
   Limited potential due to aggressive generic competition; future growth depends on new indications or formulations.

5. What are the global regional differences in these drugs’ markets?
   Increased demand in emerging economies favors HCTZ; mature markets show declining sales for irbesartan, emphasizing the importance of regional prescribing habits.

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References

[1] IQVIA, Global Medicine Market Data, 2022.
[2] WHO, Hypertension Fact Sheet, 2021.
[3] EvaluatePharma, ARB Market Forecast, 2022.