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. Twelve 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:	127
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

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

International Patents for AVALIDE

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

Country	Patent Number	Title	Estimated Expiration
Austria	167475
Australia	2286892
Australia	641005
Australia	661017

Supplementary Protection Certificates for AVALIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216

Last updated: June 12, 2026

Avalide (irbesartan + hydrochlorothiazide) market dynamics and financial trajectory

Executive summary: Avalide (irbesartan/hydrochlorothiazide, IRB/HCTZ) is an established, low-to-mid growth cardiovascular brand in most major markets, with a mature volume base and pricing pressure from ARB class competition and low-cost generics. Financial trajectory is driven by (1) patent/generic erosion, (2) payer channel mix and formulary placement for combination ARB/HCTZ, (3) competing single-pill ARBs and other diuretic combinations, and (4) safety-and-label-driven preference shifts within antihypertensive classes. Public brand revenue is limited by the long-standing generic availability in the US and the broader ARB/HCTZ class penetration globally.

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What drives Avalide (irbesartan HCTZ) pricing power and sales volume trends?

Short answer: Pricing power is structurally constrained by generic entry and ARB class competition; volume depends on formulary access and patient switching within hypertension lines.

Core demand drivers

• Indication fit: Hypertension treatment, particularly for patients needing add-on therapy from monotherapy.
• Convenience: Fixed-dose combination (FDC) improves adherence versus separate agents and helps physicians titrate to guideline-consistent regimens.
• Payer channel: Managed-care formularies increasingly favor generics and therapeutically equivalent FDCs with lower net prices. Net sales volatility is tied to:
  • rebate intensity,
  • pharmacy benefit manager (PBM) steerage,
  • step-therapy requirements,
  • brand-to-generic substitution policies.

Key headwinds

• Class-level price compression: ARBs have faced multi-wave generic competition, shifting payer preference toward lowest-cost equivalent products.
• Substitution within FDCs: Many payers treat FDCs as “clinically interchangeable” within the ARB/HCTZ subset, enabling rapid switching.
• Physician prescribing inertia: Despite FDC convenience, prescribers can revert to cheaper generic combinations or other ARBs depending on local reimbursement.

Fast indicators to monitor

• Retail and mail-order volume share for IRB/HCTZ FDCs.
• “Net-to-gross” compression for the remaining branded channel (if any).
• Formulary inclusion vs exclusion events and prior authorization rates for ARB/HCTZ combinations.

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When did generic competition erode Avalide in the US and what does that do to revenue?

Short answer: US brand dynamics for Avalide are dominated by patent expiry and generic entry timelines; once generics are entrenched, brand revenues typically shift to small residual pockets (channel contracts, coverage exceptions, or slow-switching).

Typical post-generic revenue shape

• Initial drop: Sharp unit decline as pharmacists and PBMs move to lower WAC/net alternatives.
• Stabilization: Residual branded sales persist if brand pricing remains competitive within specific formularies or if prescribers continue prescribing the brand for specific patient history.
• Long tail: Revenue declines slower once generics become the default and the brand becomes a specialty or niche option.

Commercial implication

For Avalide, the financial trajectory in mature markets usually aligns with a transition from brand-led growth to generic-dominated steady-state, where revenue exposure declines and the remaining branded contribution is mostly defensive.

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How does Avalide compare with other ARB/HCTZ fixed-dose combinations on market access and substitution risk?

Short answer: Avalide faces high substitution risk because multiple ARB/HCTZ FDCs exist, many available as generics with strong cost advantages.

Competitive set (therapeutic equivalence perspective)

• Other ARB/HCTZ FDCs (class and diuretic partner substitution)
• Single-entity ARBs plus separate generic HCTZ titration (often cheaper or preferred under PBM tier rules)
• Competing antihypertensive FDC classes in formularies (ACEI/HCTZ, ARB/CCB, ACEI/CCB)

What determines share loss

• Copay and formulary tiering: Even small copay differences can shift adherence and switching.
• Tablet strength mix: Availability of preferred strength ranges can decide which FDC is stocked in pharmacy networks.
• Contracting: PBM and distributor contracts strongly influence effective market share.

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What formulation strengths and dosing ranges matter most for Avalide uptake?

Short answer: Brand and generic market share usually tracks the most commonly prescribed strength combinations and patient populations needing specific BP reductions.

Strength mix as a commercial lever

• Common clinical patterns drive demand:
  • patients insufficient on monotherapy,
  • patients needing a mid-dose diuretic component to reach BP targets,
  • older patients with co-morbidities where clinicians prefer FDC simplicity.

Where brands can still win

• Limited formularies or coverage restrictions may still protect branded products, but the structural advantage is weaker once generics have equivalent strength availability.

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How do payer dynamics and reimbursement rules affect Avalide net sales more than wholesale demand?

Short answer: Net sales are typically shaped more by rebate structures, PBM formulary behavior, and switching friction than by underlying patient hypertension prevalence.

Mechanisms

• Rebate and access: Brand rebates can temporarily preserve formulary positions but are increasingly difficult post-generic.
• Tier placement: A one-tier movement can change demand materially.
• Step therapy and PA: Requirements can slow switching, creating brief windows of brand protection.

Commercial reporting signals

• Net sales per script (NBRx): declines signal increased generic substitution even if overall BP prevalence is stable.
• Script share by strength: narrow strength shortages can temporarily benefit the incumbent.
• Contract pricing with major channels: distributor pricing changes can move demand quickly.

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What is the likely financial trajectory of Avalide across major geographies (US, EU, UK)?

Short answer: Trajectory is mature and shaped by generic presence. US is typically the fastest in erosion; EU/UK depends on local patent status and generic penetration pace.

US (expected profile)

• Brand exposure compresses quickly after generic dominance.
• Remaining branded sales often reflect:
  • formulary exceptions,
  • slow switching for stable patients,
  • contractual channel-specific placements.

EU and UK (expected profile)

• Similar direction, typically with:
  • strong reliance on local tendering,
  • accelerated erosion where multiple bioequivalent/generic FDCs exist,
  • pricing actions linked to national health service procurement rules.

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What patent and exclusivity dynamics matter for Avalide’s remaining commercial protection?

Short answer: Avalide’s financial trajectory is largely determined by when specific IP blocks ended (composition, method, and formulation) and whether any “evergreening” patents delayed generic entry in certain jurisdictions.

What to check in an IP model

• Composition of matter coverage for irbesartan + HCTZ FDC.
• Formulation patents tied to release profile, particle engineering, or stability.
• Method-of-use claims tied to dosing regimens.
• Jurisdiction-specific status and any court-imposed entry timing.

(Patent filing and expiration dates determine the speed and shape of revenue decline. For Avalide, the overall market pattern consistent with an established ARB FDC indicates most major blocks have already expired or are outweighed by generic availability.)

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What legal and Paragraph IV risks matter for Avalide comparators rather than the brand itself?

Short answer: Once generic entry occurs, the legal focus often shifts to generic challengers and settlement timing rather than ongoing brand growth.

Settlement and entry timing impact

• A delayed generic launch sustains brand unit share and margins for the protected window.
• Settlement terms can include launch-date commitments that affect:
  • script share capture timing,
  • price levels in the immediate post-launch period.

Litigation-driven revenue effects

• Revenue impact is usually front-loaded during the launch delay window.
• After generic entrenchment, price compression dominates.

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How do safety and labeling considerations influence Avalide demand within hypertension therapy?

Short answer: Safety signals in the ARB/HCTZ class can shift prescribing preferences, but broad hypertension needs keep baseline demand stable.

Common prescribing sensitivities

• Electrolyte disturbances (HCTZ-related) can influence tolerance and continuation rates.
• Renal function considerations and monitoring requirements affect clinician willingness to switch patients abruptly.

Commercial impact

• Safety-driven caution typically affects persistence and switching speed rather than prevalence-based demand.
• In mature markets, payer pressure generally wins over nuanced patient-level preference unless a clinician documents intolerance.

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What do market dynamics imply for future Avalide revenue exposure versus generic ARB/HCTZ?

Short answer: Branded revenue exposure continues to shrink unless Avalide retains unique access, strength coverage, or special contracts in specific channels.

Revenue exposure drivers

• Generic share of prescriptions: Dominant factor in net sales erosion.
• Net pricing: Brand net price may fall due to contracting and competitive pressure.
• Mix shift: If physicians shift to other FDCs or ARB/CCB combinations, Avalide loses incremental patients even if overall FDC usage grows.

Best-case “defensive” scenario

• Branded retains a modest formulary footprint in certain payer plans.
• Limited switching due to tolerability and patient history.
• Maintenance of key strength availability.

Worst-case “structural” scenario

• PBMs move Avalide-equivalent FDCs into lower tiers.
• Additional ARB/HCTZ FDC generics expand strength supply and drive further substitution.
• Broader FDC strategy shifts (ARB/CCB or triple therapy) reduce incremental FDC ARB/HCTZ prescribing.

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Key data model for investors and commercial planners

Use this framework to quantify trajectory without relying on noisy anecdotal signals.

Market share and pricing model

Variable	What to measure	Expected direction post-generic
Unit scripts share	IMS/NBRx style share by strength	Sharp decline then stabilization
Net price	Average net sales per script, by channel	Continued downward pressure
Persistence	% of patients continuing within 3 to 12 months	Slower switching after initial disruption
Formulary status	Tier placement and PA requirements	Deteriorates over time
Strength mix	Share of strengths most common in practice	Shifts toward best-priced strengths

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Key Takeaways

• Avalide’s market dynamics are dominated by generic substitution, payer contracting behavior, and ARB class competitive pressure, not underlying hypertension incidence.
• The financial trajectory in mature markets is typically a declining-branded profile after generic entrenchment, with residual sales supported only by formulary pockets and switching friction.
• Competitive risk is high because multiple ARB/HCTZ fixed-dose options allow rapid payer-driven switching.
• Future exposure depends on strength mix, tier placement, PA policies, and net pricing, not clinical differentiation alone.

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FAQs

1) What is the main commercial risk for Avalide after generic launches?
PBM tiering and rebate economics that push scripts toward the lowest-cost equivalent ARB/HCTZ FDC.

2) Does patient adherence drive Avalide brand retention versus separate generic components?
It can in the short term, but payer cost controls and strength-equivalent generic availability usually overwhelm adherence advantages over time.

3) How quickly can Avalide sales change after a formulary or PA policy update?
Often within a single quarter, because substitution at the pharmacy and PBM steering affects prescriptions rapidly.

4) Which competitive category most threatens Avalide beyond other ARB/HCTZ FDCs?
ARB/CCB fixed-dose combinations and other antihypertensive FDC strategies that can be preferred under formulary cost rules.

5) What metrics best forecast Avalide revenue trajectory going forward?
Script share by strength, net sales per prescription, and changes in formulary tier and prior authorization frequency.

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References (APA)

No specific sources were cited because the prompt does not include verifiable financials, FDA/Orange Book status listings, or jurisdiction-level patent/litigation records for Avalide.