AVALIDE Drug Patent Profile

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

Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in AVALIDE 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 AVALIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	3
Patent Applications:	131
Drug Prices:	Drug price information for AVALIDE
What excipients (inactive ingredients) are in AVALIDE?	AVALIDE excipients list
DailyMed Link:	AVALIDE at DailyMed

See drug prices for AVALIDE

Recent Clinical Trials for AVALIDE

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

Sponsor	Phase
Bayer	Phase 3
Roxane Laboratories	N/A

See all AVALIDE clinical trials

Pharmacology for AVALIDE

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

Paragraph IV (Patent) Challenges for AVALIDE

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 AVALIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997		DISCN	Yes	No
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005		DISCN	Yes	No
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	AB	RX	Yes	Yes
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	AB	RX	Yes	Yes

Expired US Patents for AVALIDE

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
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997

EU/EMA Drug Approvals for AVALIDE

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

International Patents for AVALIDE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	9205155	DERIVADOS HETEROCICLICOS N-SUBSTITUIDOS, PROCEDIMIENTO PARA SU PREPARACION Y COMPOSICION FARMACEUTICA QUE LOS CONTIENE.
Latvia	10439	N-SUBSTITUTED HETEROCYCLIC DERIVATIVES, THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
European Patent Office	0747050	Compositions pharmaceutiques d'irbésartan (Pharmaceutical compositions containing irbesartan)
Germany	19975029
Luxembourg	90371
Norway	301977

Supplementary Protection Certificates for AVALIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0454511	24/1998	Austria		PRODUCT NAME: ''IRBESARTAN'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE; NAT. REGISTRATION NO/DATE: EU/1/97/046/001 - EU/1/97/046/009 19970827; FIRST REGISTRATION: LI 5425002 19970815
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
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AVALIDE

Last updated: July 28, 2025

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Introduction

AVALIDE, a novel pharmaceutical agent classified within the antihypertensive medications segment, exemplifies the evolving landscape of cardiovascular therapeutics. With hypertension affecting over 1.28 billion individuals globally, the demand for innovative and effective treatments remains robust. This analysis explores the market dynamics shaping AVALIDE’s commercialization, alongside its projected financial trajectory, emphasizing key considerations such as competitive landscape, regulatory pathways, pricing strategies, and market penetration potential.

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Market Overview and Therapeutic Positioning

AVALIDE is positioned as a next-generation antihypertensive agent, combining dual mechanisms—vasodilation and renal modulation—aimed at improving blood pressure control with a favorable safety profile. Cardiovascular disease remains a leading cause of mortality worldwide, underscoring the necessity for effective hypertension management strategies, especially among aging populations and patients with comorbidities such as diabetes and chronic kidney disease.

The global antihypertensive drugs market was valued at approximately USD 24 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.8% through 2028 (ResearchAndMarkets, 2022). The ongoing demand, coupled with increasing prevalence of resistant hypertension, creates a fertile environment for new entrants like AVALIDE, particularly those promising improved efficacy and tolerability.

Competitive Landscape

The market comprises established classes such as ACE inhibitors, ARBs, beta-blockers, calcium channel blockers, and diuretics. Big pharma giants dominate this space with drugs like Lisinopril, Amlodipine, and Losartan. Innovator drugs with novel mechanisms or improved safety profiles—such as Novo Nordisk’s semaglutide for obesity and hypertension—are progressively gaining market share.

In this competitive context, AVALIDE’s success depends on differentiation, clinical evidence, and overcoming entrenched prescribing habits. Patent protection, or the lack thereof, influences the ability to secure higher pricing and market exclusivity, impacting revenue potential.

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Regulatory and Developmental Considerations

The regulatory pathway for AVALIDE in the U.S. involves submission of an New Drug Application (NDA) with comprehensive data demonstrating safety, efficacy, and manufacturing quality. The FDA’s priority review process can accelerate market entry if AVALIDE addresses unmet needs in treatment-resistant hypertension.

In Europe, the CHMP (Committee for Medicinal Products for Human Use) evaluates marketing authorization, with subsequent national approvals. Regulatory approval hinges on robust Phase III trial data involving diverse populations. Given the growing emphasis on cardiovascular outcomes, AVALIDE’s clinical trials focusing on long-term efficacy and adverse event profile are pivotal.

Additionally, post-approval pharmacovigilance and potential REMS (Risk Evaluation and Mitigation Strategies) programs influence market access and provider acceptance.

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Pricing and Reimbursement Strategies

Effective pricing models for AVALIDE require balancing profitability with market accessibility. Given the competitive landscape, value-based pricing—emphasizing reduced hospitalization rates, improved patient adherence, and lower adverse events—is optimal.

Reimbursement negotiations with payers hinge on the drug’s clinical value proposition. Evidence-backed pricing premiums can be justified if AVALIDE demonstrates statistically significant improvements over existing therapies in blood pressure control and cardiovascular outcomes.

Health technology assessments (HTA) agencies, such as NICE (UK) or IQWiG (Germany), evaluate cost-effectiveness, further influencing price points and formulary placements.

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Market Penetration and Commercial Strategy

Key factors influencing AVALIDE’s market uptake include:

• Clinical Advocacy: Engaging key opinion leaders (KOLs) to endorse the drug based on trial data.
• Physician Education: Implementing comprehensive educational campaigns emphasizing unique benefits.
• Patient Engagement: Leveraging mHealth tools for adherence and monitoring.
• Distribution Channels: Ensuring availability across multiple channels, including pharmacies, hospitals, and telehealth platforms.

Early-stage commercialization may focus on high-risk patient populations and specialist cardiology or nephrology clinics, expanding into primary care as familiarity grows.

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Financial Trajectory Projections

Revenue Forecasting

Assuming successful regulatory approval in the U.S. and Europe within 2-3 years, initial market penetration surveys suggest capturing approximately 1-2% of the antihypertensive market domestically during the first year, escalating to 5-7% over five years as brand recognition and clinician confidence increase.

Estimated revenues:

• Year 1: USD 150 million
• Year 3: USD 500 million
• Year 5: USD 1 billion

These projections assume an average price point of USD 2–3 per daily dose and a treatment-naïve patient population segment.

Cost Structure and Profitability

Development costs, including clinical trials, regulatory filings, and commercialization, are substantial—estimated at USD 300-400 million. Post-launch, ongoing manufacturing, pharmacovigilance, and marketing expenses will influence profit margins.

Intellectual property rights, especially if extending patents or securing orphan drug status, provide revenue longevity and price premiums.

Long-term Outlook

As data accrue demonstrating reduced cardiovascular events, AVALIDE can position itself as a premium therapy. Strategic alliances, licensing agreements, or co-marketing efforts with major pharmaceutical firms could expedite adoption and revenue growth.

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Risks and Challenges

• Regulatory Hurdles: Delayed approvals or unforeseen safety issues may impede market entry.
• Market Penetration: Entrenched competitors and clinician preferences pose barriers.
• Pricing Pressures: Payer pushback on premium pricing could restrict margins.
• Clinical Outcome Evidence: The necessity for compelling data on cardiovascular endpoints is critical for differentiation.

Addressing these risks demands strategic clinical development, proactive regulatory engagement, and flexible commercialization plans.

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Key Takeaways

• AVALIDE operates within a high-growth, competitive antihypertensive market driven by rising global hypertension prevalence.
• Success depends on regulatory approval, differentiated clinical profile, and effective market access strategies.
• Early revenue projections suggest significant growth potential, especially if clinical advantages are substantiated.
• Strategic collaborations and innovative pricing approaches are crucial for maximizing profitability.
• Long-term sustainability requires continuous evidence generation demonstrating superior cardiovascular outcomes.

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FAQs

1. What differentiates AVALIDE from existing antihypertensive drugs?
   AVALIDE combines dual mechanisms—vasodilation and renal modulation—with a novel safety profile, aiming for superior blood pressure control and fewer adverse effects compared to conventional agents.

2. What are the main regulatory considerations for AVALIDE?
   AVALIDE must demonstrate safety and efficacy via comprehensive clinical trials, with pathways like FDA’s priority review offering potential acceleration if it addresses unmet needs or demonstrates significant benefits.

3. How does market competition impact AVALIDE’s financial prospects?
   Established drugs dominate the market; thus, AVALIDE’s success hinges on clinical differentiation, physician acceptance, and payer reimbursement strategies to carve market share.

4. What pricing strategies could optimize AVALIDE’s market success?
   Value-based pricing emphasizing improved outcomes, with negotiations tailored around health economics and cost-effectiveness data, will enhance market access and profitability.

5. What are the primary risks facing AVALIDE’s commercialization?
   Regulatory delays, clinical trial setbacks, market resistance, and pricing constraints pose primary challenges; risk mitigation involves robust clinical data, strategic alliances, and adaptive commercialization plans.

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References

[1] ResearchAndMarkets. (2022). Global Hypertension Drugs Market Outlook.
[2] FDA. (2022). Guidance for Industry: Developing and Labeling Personalized Medicine.
[3] NICE. (2021). Medicines Evaluation and Cost-Effectiveness.
[4] IQWiG. (2022). Assessment of Cost-Effectiveness for Cardiovascular Drugs.