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-three 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

Expired US Patents for AVAPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997	5,270,317*PED
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	6,342,247*PED
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997	6,342,247*PED
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	5,270,317*PED

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

International Patents for AVAPRO

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	442301
Finland	103407
Australia	702651
Argentina	054782	COMPOSICIONES FARMACEUTICAS Y TABLETAS QUE CONTIENEN IRBESARTAN EN COMBINACION CON UN DIURETICO

Supplementary Protection Certificates for AVAPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454511	10/1999	Austria		PRODUCT NAME: ''IRBESARTAN'' ZUSAMMEN MIT ''HYDROCHLOROTHIAZID''; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015
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	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	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Market Dynamics and Financial Trajectory for AVAPRO (Irbesartan)

Last updated: February 20, 2026

What is the Current Market Position of AVAPRO?

AVAPRO (irbesartan) is an angiotensin II receptor blocker (ARB) approved for treating hypertension and diabetic nephropathy. It is marketed mainly in the United States, Europe, and emerging markets by Boehringer Ingelheim, its originator. As of 2023, AVAPRO holds a moderate share within the ARB segment, competing primarily with drugs like losartan, valsartan, and candesartan.

• Estimated global sales of irbesartan were approximately $500 million in 2022, representing a decline of roughly 8% from 2021, driven by generic competition and market saturation.
• In the U.S., AVAPRO's annual revenue has been stabilizing around $300 million, with off-patent status influencing price competition.
• In Europe, sales remain around $100 million, but intensity from generics has led to price erosion.

What Are the Key Market Drivers and Challenges?

Drivers

• Increasing prevalence of hypertension and diabetic nephropathy: These conditions drive consistent demand for ARBs, including AVAPRO.
• Strong clinical evidence: IRBESARTAN has been validated for reducing cardiovascular risks and delaying progression of diabetic nephropathy, reinforcing prescriber confidence.
• Growing geriatric population: Older demographics are more prone to hypertension, expanding market size globally.

Challenges

• Patent expiry and generics: Patents for AVAPRO expired in most markets by 2018, leading to significant price pressure. Generics now account for over 90% of prescriptions for irbesartan.
• Market saturation: Most patients already on ARBs have switched either to generics or combination therapies.
• Competitive landscape: Other ARBs and ACE inhibitors offer similar efficacy at lower prices, hindering AVAPRO's market share growth.

How Is the Financial Trajectory Expected to Evolve?

Revenue Trends

• Decline trajectory: From peaks of over $700 million globally in 2014, revenue declined by approximately 30% through 2022.
• Post-patent scenario: Generic competition accounts for 85-90% of irbesartan prescriptions, exerting downward pressure on average selling prices.
• Potential stabilization: In markets with brand loyalty or unique formulation advantages, revenue could stabilize but unlikely to return to peak levels.

Cost Structure and Profitability

• Manufacturing costs for generic versions average 15-20% lower than branded AVAPRO, affecting margins.
• Marketing expenses have decreased in line with sales volume, but investments in patient and prescriber education remain, especially for combo formulations.

Market Expansion and Opportunities

• Emerging markets represent growth potential due to increasing hypertension awareness; sales in Asia-Pacific grew 5% annually from 2018-2022.
• Combination therapies: Developing fixed-dose combinations with diuretics or calcium channel blockers could sustain revenue streams.
• New indications or formulations: Patents for specific formulations or delivery methods could provide short-term revenue boosts.

What Are the Key Competitors and Market Shares?

Product	Market Share (2022)	Key Markets	Patents	Notes
Irbesartan (AVAPRO)	6%	U.S., Europe, Latin America	Expired	Main competitor: generic irbesartan
Losartan (Cozaar)	42%	U.S., Europe, Asia	Expired	Slightly less effective in renal protection
Valsartan (Diovan)	24%	U.S., Europe, Asia	Expired	Switched focus to hypertensive trials
Candesartan (Atacand)	8%	Europe, Asia	Expired	Niche in heart failure therapy

What Regulatory and Policy Trends Affect Future Revenue?

• Generic drug policies favor price competition, especially in markets with robust regulatory frameworks like the US FDA, EMA, and Japanese PMDA.
• Pricing reforms in European countries, aiming to reduce health expenditure, pressure branded drug prices.
• Patent challenges: Litigation on patent extensions can temporarily delay generic entry, but the trend favors rapid market penetration of generics globally.

Conclusion

The financial trajectory of AVAPRO is characterized by declining revenues driven by patent expiration and market saturation. Opportunities remain in targeted markets, combination therapies, and new formulations, but overall growth prospects are limited. Market share is expected to plateau at low-single digits in mature regions.

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Key Takeaways

• AVAPRO's revenue dipped 30% from peak sales in 2014, primarily due to patent expiry and generic competition.
• The global ARB market is mature, with generics holding majority share.
• Opportunities exist in emerging markets and fixed-dose combinations; however, pricing pressures persist.
• Regulatory policies increasingly favor cost-effective generics, constraining branded drug revenues.
• Strategic focus on niche indications and formulations may provide short-term stabilizations.

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FAQs

1. When did AVAPRO lose patent protection?
   In most markets, patent protection expired by 2018.

2. What is the main competitor to AVAPRO?
   Generic irbesartan accounts for over 85% of prescriptions, with branded competitors like Cozaar (losartan) and Diovan (valsartan) also competing in the ARB segment.

3. Are there new formulations or indications for AVAPRO?
   As of 2023, no new patents or indications are under regulatory review; focus remains on existing formulations.

4. Can AVAPRO regain market share?
   Limited potential due to generic competition; focus may shift to niche markets or combination products.

5. What is the outlook for IRBESARTAN in emerging markets?
   Emerging markets show steady growth, driven by increasing hypertension prevalence and less aggressive price competition compared to developed markets.

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References

[1] IMS Health. (2023). Global Pharmaceutical Market Trends.
[2] Boehringer Ingelheim. (2023). AVAPRO (Irbesartan) Product Data.
[3] IQVIA. (2022). World Pharmaceutical Markets Report.
[4] European Medicines Agency. (2018). Summary of Product Characteristics for Irbesartan.
[5] Food and Drug Administration. (2018). Drug Patent and Exclusivity Data.