IRBESARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile

When do Irbesartan And Hydrochlorothiazide patents expire, and when can generic versions of Irbesartan And Hydrochlorothiazide launch?

Irbesartan And Hydrochlorothiazide is a drug marketed by 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 fifteen NDAs.

The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for IRBESARTAN AND HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	12
Clinical Trials:	16
What excipients (inactive ingredients) are in IRBESARTAN AND HYDROCHLOROTHIAZIDE?	IRBESARTAN AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	IRBESARTAN AND HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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 IRBESARTAN AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for IRBESARTAN AND HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077369-003	Mar 30, 2012		DISCN	No	No
Sandoz	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077446-001	Sep 27, 2012	AB	RX	No	No
Unichem	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	207018-001	Sep 19, 2017		DISCN	No	No
Sandoz	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077446-002	Sep 27, 2012	AB	RX	No	No
Alembic	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	091370-001	Oct 15, 2012	AB	RX	No	No
Hisun Pharm Hangzhou	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	207896-002	Oct 14, 2016	AB	RX	No	No
Pharmobedient	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077969-002	Sep 27, 2012		DISCN	No	No

EU/EMA Drug Approvals for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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
Bristol-Myers Squibb Pharma EEIG	Irbesartan Hydrochlorothiazide BMS	irbesartan, hydrochlorothiazide	EMEA/H/C/000784Treatment of essential hypertension.This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).	Withdrawn	no	no	no	2007-01-19

Market Dynamics and Financial Trajectory for Irbesartan and Hydrochlorothiazide

Last updated: August 7, 2025

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Introduction

Irbesartan combined with hydrochlorothiazide (commonly branded as Avalide, Avaluth, or by various generic names) represents a significant segment within the antihypertensive pharmaceutical market. This fixed-dose combination (FDC) leverages two well-established agents—irbesartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic—to optimize blood pressure control. Understanding its market dynamics and financial trajectory is crucial for healthcare stakeholders, including pharmaceutical companies, investors, and policy makers.

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Market Overview

The global antihypertensive market, driven by rising hypertension prevalence, aging populations, and increasing awareness, has seen steady growth. Irbesartan and hydrochlorothiazide constitute a core component in this landscape, favored for their complementary mechanisms and proven efficacy.

In 2022, the global antihypertensive drugs market was valued at approximately $17 billion, with ARBs occupying around 20% of the total market share. The segment for fixed-dose combinations (FDCs), including irbesartan/hydrochlorothiazide, has been expanding rapidly, owing to improved adherence, simplified regimens, and favorable safety profiles.

Market Share:

• Irbesartan, branded initially by Sanofi and later marketed broadly as generics, remains a key ARB despite rising competition from newer agents like losartan and olmesartan.
• Hydrochlorothiazide remains one of the most prescribed diuretics globally, underpinning the stability of the combination.

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Key Market Drivers

1. Increasing Hypertension Prevalence: Hypertension affects over 1.3 billion people worldwide, with an estimated 30-35% of adults affected globally, fueling demand for effective medications [1].
2. Efficacy of Combination Therapy: Fixed-dose combinations like irbesartan/hydrochlorothiazide improve patient compliance and reduce cardiovascular risk, prompting prescribers to favor such formulations [2].
3. Generic Penetration: The expiration of patent protections has led to increased availability of generic formulations, reducing costs and expanding access, especially in emerging markets.
4. Healthcare Policies: Governments and insurers are incentivizing the use of cost-effective, fixed-dose regimens to adhere to hypertension treatment guidelines.

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Competitive Landscape and Market Challenges

While the FDC of irbesartan and hydrochlorothiazide benefits from a well-established efficacy profile, it faces intense competition:

• Emerging ARBs and ACE inhibitors: Losartan, candesartan, and olmesartan are vying for market share, often at lower costs.
• Direct-Acting Novel Agents: The introduction of drugs with novel mechanisms (e.g., SGLT2 inhibitors) influences hypertension treatment paradigms.
• Pricing Pressures: Patent expiries and generic competition suppress pricing, affecting revenue streams.

Regulatory hurdles and the necessity for ongoing clinical validation further influence market dynamics, necessitating continuous innovation and strategic positioning.

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Financial Trajectory and Revenue Outlook

Historical Perspective:
Historically, the revenues derived from irbesartan/hydrochlorothiazide formulations have been stable, with peak sales observed in the late 2010s. For instance, Sanofi reported significant contributions from Avalide before patent expiration led to price erosion and generic competition.

Impact of Patent Expirations:
The key patent for irbesartan expired in the U.S. in 2018, leading to a proliferation of generics. Similar expiries in other jurisdictions decreased brand-specific revenues but expanded market volume overall.

Post-Patent Strategies:
Pharmaceutical companies shifted focus toward underlying molecules, biosimilars, or novel combinations. Some firms have introduced extended-release formulations or dual therapies with additional cardiovascular agents to sustain revenue.

Market Growth Projections:
By 2027, the antihypertensive market is projected to reach $26 billion, with fixed-dose combinations expected to comprise a significant share. The irbesartan/hydrochlorothiazide segment is anticipated to grow at a compounded annual growth rate (CAGR) of approximately 3-5% driven by emerging market expansion and ongoing clinical endorsements.

Emerging Markets:
Regions such as Asia-Pacific, Latin America, and Africa exhibit rapid growth due to increasing healthcare infrastructure and population aging, presenting lucrative opportunities despite price sensitivity.

Investments in R&D:
Future revenues are contingent upon pipeline developments, including new formulations, delivery systems, or combination therapeutics aimed at improving compliance and outcomes.

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Regulatory and Pricing Factors

Regulatory environments directly influence financial outcomes:

• Stringent approval processes may delay product launches.
• Price controls in many jurisdictions (e.g., India, Europe) affect margins.
• Healthcare reimbursement policies increasingly favor generics and FDCs for cost containment.

In the U.S., pricing declines post-patent expiry have been offset by volume growth, but global markets exhibit more diverse trends, often favoring low-cost generics over branded formulations.

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Future Outlook

The landscape for irbesartan/hydrochlorothiazide is expected to evolve with:

• Technological Advances: Development of extended-release formulations, combination patches, or nanotechnology-based delivery may enhance therapeutic efficacy and adherence.
• Personalized Medicine: Biomarker-driven approaches could optimize patient selection and dosing.
• Regulatory Incentives: Policies supporting generic substitution and incentives for fixed-dose combinations will sustain demand.
• Market Penetration: Increasing awareness and healthcare infrastructure improvements will boost sales in underserved regions.

Overall, while patent expiries pose challenges, strategic innovation and market expansion can sustain the financial trajectory, with revenues stabilizing and gradually growing in emerging markets.

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Key Takeaways

• The irbesartan and hydrochlorothiazide market remains integral to hypertension management, benefiting from the global rise in cardiovascular disease.
• Patent expiry and generic competition have stabilized revenues but prompted shifts toward innovative formulations and markets.
• Emerging economies offer vast growth opportunities driven by expanding healthcare access and aging populations.
• Future success hinges on R&D investments, strategic geographic expansion, and adherence to evolving regulatory landscapes.
• The market's resilience depends on balancing cost-effectiveness with innovations that enhance patient compliance and therapeutic outcomes.

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FAQs

1. How does patent expiration impact the revenue potential of irbesartan/hydrochlorothiazide products?
Patent expiry typically leads to the entry of generics, significantly reducing brand-name drug prices and revenues. However, overall market volume may increase due to lower costs and broader access, offsetting some revenue losses.

2. What are the primary competitors to irbesartan/hydrochlorothiazide?
Competing agents include other ARB/hydrochlorothiazide combinations like losartan/hydrochlorothiazide and olmesartan/hydrochlorothiazide, as well as alternative antihypertensive classes like ACE inhibitors and calcium channel blockers.

3. Which markets are expected to drive future growth for this drug combination?
Emerging markets such as India, China, and Latin America hold significant potential due to rising hypertension prevalence and expanding healthcare infrastructure.

4. What role does regulatory policy play in shaping the financial trajectory?
Regulatory approvals, patent protections, and pricing regulations influence market access, pricing strategies, and ultimately revenue streams, especially in jurisdictions with strict drug pricing controls.

5. Are there ongoing R&D efforts aimed at improving irbesartan/hydrochlorothiazide formulations?
Yes, companies are exploring sustained-release formats, combination therapies for comorbidities, and novel delivery systems to boost adherence and therapeutic effectiveness.

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References

[1] World Health Organization. Hypertension Fact Sheet. 2021.
[2] Gupta AK, Arshad S, Poulter NR. "Compliance, safety, and efficacy of fixed-dose combinations of antihypertensives: An overview." J Clin Hypertens. 2010;12(10):769-762.