AVAPRO Drug Patent Profile

Which patents cover Avapro, and when can generic versions of Avapro launch?

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

The generic ingredient in AVAPRO is irbesartan. There are thirty-eight drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the irbesartan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avapro

A generic version of AVAPRO was approved as irbesartan by TEVA PHARMS on March 30^th, 2012.

Summary for AVAPRO

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	14
Drug Prices:	Drug price information for AVAPRO
What excipients (inactive ingredients) are in AVAPRO?	AVAPRO excipients list
DailyMed Link:	AVAPRO at DailyMed

See drug prices for AVAPRO

See drug sales revenues for AVAPRO

Recent Clinical Trials for AVAPRO

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

Sponsor	Phase
Syneos Health	Phase 1/Phase 2
Bill and Melinda Gates Foundation	Phase 1/Phase 2
University of Sierra Leone	Phase 1/Phase 2

See all AVAPRO clinical trials

Pharmacology for AVAPRO

Drug Class	Angiotensin 2 Receptor Blocker
Mechanism of Action	Angiotensin 2 Receptor Antagonists

Paragraph IV (Patent) Challenges for AVAPRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVAPRO	Tablets	irbesartan	75 mg, 150 mg and 300 mg	020757	1	2004-05-25

US Patents and Regulatory Information for AVAPRO

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	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997		DISCN	Yes	No
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	AB	RX	Yes	No
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	AB	RX	Yes	Yes

EU/EMA Drug Approvals for AVAPRO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Winthrop Industrie	Karvea	irbesartan	EMEA/H/C/000142Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal product regimen.	Authorised	no	no	no	1997-08-26
Sanofi Winthrop Industrie	Aprovel	irbesartan	EMEA/H/C/000141Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.	Authorised	no	no	no	1997-08-26
Zentiva k.s.	Irbesartan Zentiva (previously Irbesartan Winthrop)	irbesartan	EMEA/H/C/000785Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type-2 diabetes mellitus as part of an antihypertensive medicinal-product regimen.	Authorised	no	no	no	2007-01-19
Teva B.V.	Irbesartan Teva	irbesartan	EMEA/H/C/001093Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.	Authorised	yes	no	no	2009-10-30
Krka, d.d., Novo mesto	Ifirmasta (previously Irbesartan Krka)	irbesartan	EMEA/H/C/000962Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.	Authorised	yes	no	no	2008-12-01
Pharmathen S.A.	Sabervel	irbesartan	EMEA/H/C/002510Sabervel is indicated in adults for the treatment of essential hypertension.It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.	Withdrawn	yes	no	no	2012-04-13

International Patents for AVAPRO

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

Country	Patent Number	Title	Estimated Expiration
Austria	167475
Australia	2286892
Australia	641005
Australia	661017
Australia	7561091
Canada	2057913	DERIVES HETEROCYCLIQUES A SUBSTITUANT EN N, LEUR OBTENTION ET COMPOSITIONS PHARMACEUTIQUES OU IL S'EN TROUVE (N-SUBSTITUTED HETEROCYCLIC DERIVATIVES, THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS IN WHICH THEY ARE PRESENT)

Supplementary Protection Certificates for AVAPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	C980039	Netherlands		PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAA T; REGISTRATION NO/DATE: EU/1/97/046/001 - 009 19970827
0454511	C990006	Netherlands		PRODUCT NAME: IRBESARTAN, DESGEWENST IN DE VORM VAN EEN ZOUT EN/OF EEN HYDRAAT, EN HYDROCHLOORTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
0454511	SPC/GB98/037	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.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
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
0454511	98C0028	Belgium		PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Last updated: July 29, 2026

AVAPRO (irbesartan) market dynamics and financial trajectory: exclusivity, competitive pressure, and revenue exposure

Executive summary: AVAPRO (irbesartan) is a long-cycle branded angiotensin II receptor blocker facing sustained generic pricing pressure in the US. The branded revenue base has largely shifted from AVAPRO itself to line extensions and to contract/wholesale activity around generic ARBs. From an IP and competitive-risk standpoint, AVAPRO’s US exclusivity is structurally exhausted, leaving commercialization driven by generic penetration, formulary tiering, payer contracting, and substitution within the ARB class rather than by brand protection. The practical outcome is that AVAPRO’s financial trajectory is a continuing decline in brand sales post-generic entry, with any residual brand performance driven by pharmacy benefits manager rebate dynamics, niche payer formularies, and patient retention where substitution controls apply.

What is AVAPRO (irbesartan) and how does it compete in the ARB market?

AVAPRO is an angiotensin II receptor blocker (ARB) indicated primarily for hypertension and for renal outcomes in selected patient populations with type 2 diabetes and chronic kidney disease, depending on the labeled use and geography.

How does ARB competition shape AVAPRO pricing and share?

The ARB market is dominated by multiple molecules with broad guideline inclusion and high substitutability. AVAPRO competes head-to-head at the “class” level even when different active ingredients have different labeling nuances. Key commercial drivers:

• Therapeutic interchangeability: ARBs are interchangeable in many payer models, shifting competition to net pricing, rebate intensity, and formulary placement.
• Dose-formular breadth: Fixed-dose combinations and multiple dose strengths influence formulary adoption and pharmacy substitution behavior.
• Generic depth: In most markets, multiple generic versions of irbesartan and competing ARBs coexist, intensifying price erosion.
• Payer contracting: Managed care favors the lowest-cost alternatives meeting protocol criteria.

Which ARBs most directly compete with irbesartan?

Common ARB competitors with entrenched formulary access include losartan, valsartan, olmesartan, candesartan, and telmisartan, depending on country and payer plan design.

Implication for AVAPRO financial trajectory: once irbesartan generics are entrenched, brand performance becomes a marginal variable driven by payer rebates and contract structures rather than clinical differentiation.

When did AVAPRO lose branded exclusivity and what does that mean for financial trajectory?

Featured-snippet answer: AVAPRO’s brand economics are dominated by post-generic-entry dynamics; branded exclusivity in the US has long lapsed, and the market is driven by generic competition for irbesartan and class substitution within ARBs.

US IP timeline context (commercially relevant)

For branded ARBs, the commercial turning points are typically:

• Patent expirations for the active ingredient and key formulations or methods of use.
• Generic launch dates tied to Paragraph IV or other ANDA filings.
• Exclusivity windows (if any) tied to NDA 505(b)(2)/pediatric exclusivity or first-to-file ANDA exclusivity, where applicable.

Given the absence of specific, verified AVAPRO Orange Book entry and expiration dates in the provided input, the safest analysis is structural: AVAPRO behaves as an established, mature product whose branded revenue declines are consistent with generic saturation.

How does generic saturation translate into revenue decline?

Once generics capture the majority of fills:

• WAC-based brand revenue collapses even if unit volumes remain partly stable due to substitution.
• Net revenue depends on rebate structure; brands often face rebate deterioration because plans switch to generic-preferred tiers.
• Contract behavior shifts from “brand choice” to “lowest net cost” contracting.

What is the Orange Book status of AVAPRO and what patents protect it?

Featured-snippet answer: AVAPRO’s protected status is not a sustainable driver of current market positioning because branded exclusivity is effectively exhausted and generics dominate.

Patent estate categories that typically matter for ARBs

For irbesartan-based products, patent estate categories that historically matter include:

• Active ingredient composition of matter
• Formulation (tablet composition, coatings, release characteristics)
• Method-of-use (hypertension, diabetic nephropathy or CKD-related outcomes)
• Polymorphs and crystalline forms
• Combination products (where relevant)

How do residual patents affect generic entry risk?

In matured products, even if some secondary patents remain (eg, method-of-use or formulation), the commercial relevance is limited unless:

• A generic must avoid a specific labeled method claim to launch.
• The US regulatory label carving or approval route is constrained by those remaining claims.
• Litigation produces a meaningful “design-around” or stay.

Net effect for AVAPRO: the market dynamic is driven by generic availability of irbesartan, so brand revenue trajectory is primarily pricing and payer-driven rather than IP-blocked.

What generic entry risks exist for AVAPRO, and which ANDA filings matter?

Featured-snippet answer: Generic entry risk for AVAPRO is largely realized; the main competitive factor is not new entry but ongoing price compression and fill capture among existing generic manufacturers.

What to monitor once the market is fully generified

Even after initial generic launches, competitive intensity remains high through:

• Additional ANDA approvals increasing manufacturer count
• Launch of authorized generics (where applicable)
• Price moves driven by wholesaler and distributor competition
• PBM formulary redesign to consolidate ARB coverage to 1-2 preferred generic products

How does manufacturer count affect net pricing?

When multiple generic competitors exist:

• Wholesale acquisition cost compresses and discounts deepen.
• Net pricing becomes contract-specific with lower floor prices.
• Brand share becomes fragile, especially where substitution is automatic.

How does AVAPRO compare with other ARBs on market dynamics?

Commercial comparison framework

For ARB molecules, comparative commercial outcomes typically correlate with:

• Time of generic entry
• Generic manufacturer breadth
• Presence of combination products (often increases shelf share through formulary coverage)
• Label breadth and payer protocol alignment
• Local market policy (tendering systems in some geographies)

Likely positioning of irbesartan vs peers

Irbesartan’s commercial position generally tracks with:

• Formulary class placement: ARB preference is payer-specific.
• Cost leadership: generic irbesartan becomes a cost leader only if it is contracted below alternatives.
• Patient retention effects: limited in a fully generic environment.

Implication: the “winner” in mature ARBs is usually the molecule with the strongest contracting and the most favorable lowest-net-cost status, not necessarily the brand history.

How do payer rebates, formulary tiering, and substitution laws impact AVAPRO revenues?

Key mechanisms

• Tier placement: Generic ARBs move to preferred tiers quickly, squeezing brand access.
• Rebate intensity: Brands face pressure to increase rebates, reducing net revenue per prescription.
• Step edits and prior authorization: Once available generically, step edits often favor generic fills.
• State substitution controls: Where generic substitution is mandated, brand share declines faster.

What changes in a mature ARB market?

• Rebate negotiations shift from “volume protection” to “access preservation.”
• Plan formularies consolidate around preferred generic ARBs.
• Pharmacy benefits increasingly optimize by lowest ingredient cost with minimal clinical differentiation.

What financial trajectory should investors expect for AVAPRO (irbesartan) under current market conditions?

Featured-snippet answer: A mature branded ARB like AVAPRO has a declining branded sales trajectory, with any remaining revenue concentrated in residual brand demand, specialty contract pockets, and pharmacy channels that do not immediately substitute to generics.

Revenue shape over time in generified ARBs

Typical pattern after generics:

• Abrupt drop around the first sustained generic launch
• Plateau for a period as brands maintain niche placement
• Gradual decline as contracts re-optimize and additional generics expand
• Channel-driven volatility driven by wholesaler inventory cycles and short-term rebates

What parts of the business can still move?

Even when branded sales are under pressure:

• Broader corporate revenue can stabilize through other product lines.
• Generic distribution or manufacturing economics can exist depending on corporate structure.
• Brand volumes can hold in markets with slower substitution or where payers limit switching.

What litigation and settlements historically matter for AVAPRO’s competitive positioning?

Featured-snippet answer: For matured branded products, litigation may matter primarily at the time of first generic launches through stays and settlements. After widespread generics exist, ongoing impact is limited to incremental market share shifts among generic entrants.

What litigation impacts the market most?

• Settlement agreements that delay generic approval or launch
• Court rulings that determine whether specific claims are invalid or unenforceable
• Design-around changes that enable earlier entry

Implication: for AVAPRO’s current era, the litigation relevance is historical unless a new round of secondary patents restrict labeling or method-of-use claims.

What is the FDA regulatory status of AVAPRO, and how does it drive market access?

AVAPRO is an approved NDA product with generic equivalents approved through ANDAs.

Why FDA status matters less after full generic saturation

Once multiple ANDAs are approved:

• Prescribing is driven by payer economics, not regulatory novelty.
• FDA status mainly affects label differences (if any) and interchangeability rather than brand viability.

What would create regulatory tailwinds?

Regulatory changes that could support brand-like uptake include:

• Expanded indications (label broadening)
• New dosage forms or combinations
• Promotional re-expansion where generics lag

For a mature ARB, those catalysts are uncommon.

Geographic dynamics: how does AVAPRO performance vary by country?

Common cross-market patterns for generic ARBs

• Markets with aggressive tendering and generic substitution show faster price erosion.
• Markets with slower switching retain marginal brand performance longer.
• Variability in IRB and HTA reimbursement criteria influences which ARBs are preferred.

What tends to dominate outside the US?

• National formulary status and reimbursement tiers
• Tendering and procurement rules
• Competitive generic count

Key Takeaways

• AVAPRO (irbesartan) is a mature, largely generified ARB where brand financial trajectory is dominated by generic price compression and payer-driven formularies rather than active IP control.
• Competitive pressure comes from class interchangeability across ARBs and deep generic availability of irbesartan and alternatives.
• The primary commercial levers for any remaining branded use are rebates, tier placement, and substitution policies.
• Near-term market dynamics are typically about contracting and lowest-net-cost contracting rather than new scientific differentiation.

FAQs

1. How do PBMs typically tier generic ARBs versus a brand like AVAPRO?
2. What dosing strengths or formulations most affect AVAPRO switching to generics?
3. Do method-of-use patents for irbesartan materially delay generic competition after first entry?
4. How does generic competition among ARBs influence net pricing differently than gross WAC?
5. What indicators best predict remaining branded demand for AVAPRO in a fully generified market?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ .
2. DrugPatentWatch / regulatory and litigation trackers. https://www.drugpatentwatch.com/ .
3. FDA Label (AVAPRO). US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ .