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
University of Sierra Leone	Phase 1/Phase 2
INC Research	Phase 1/Phase 2
University of North Carolina	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	020757-003	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997

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

International Patents for AVAPRO

See the table below for patents covering AVAPRO 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)

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	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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AVAPRO

Last updated: July 30, 2025

Introduction

AVAPRO, the brand name for the angiotensin II receptor blocker (ARB) irbesartan, has established itself as a key player in the management of hypertension and diabetic nephropathy. Since its approval, AVAPRO has navigated evolving market conditions influenced by regulatory changes, competitive dynamics, and healthcare trends. This analysis explores the current market landscape, factors shaping its financial trajectory, and strategic opportunities for stakeholders.

Market Overview

Therapeutic Segment and Demand Drivers

AVAPRO operates primarily within the antihypertensive and nephrology segments. The global prevalence of hypertension, estimated at over 1.3 billion individuals (WHO, 2021), sustains consistent demand for effective agents like AVAPRO. Furthermore, the rising incidence of diabetic nephropathy—affording additional therapeutic relevance to irbesartan—amplifies its market potential.

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulate ARBs under rigorous standards. The expiration of basic patents and the subsequent proliferation of generic versions have significantly impacted AVAPRO's market share. Generic entry typically correlates with substantial price erosion, influencing revenue streams and market positioning.

Market Competition

The ARB class faces competition from multiple drugs, notably losartan, valsartan, and newer agents like azilsartan. The competitive landscape is further complicated by patent litigations and biosimilar developments. For example, the expiration of irbesartan’s patent in the U.S. in 2017 precipitated a sharp decline in branded sales, replaced largely by generics.

Financial Trajectory

Revenue Trends and Market Share

Initially, AVAPRO experienced robust growth, driven by its efficacy and favorable safety profile. However, patent expirations led to a steep decline in branded sales. According to IQVIA data, in the U.S., AVAPRO’s sales peaked around 2012, with subsequent rapid decline post-generic entry [1]. Globally, the drug's revenue profile has similarly shifted, with revenues increasingly attributable to generics.

Pricing Dynamics

While brand-name AVAPRO commanded premiums, the advent of generics caused a steep price reduction—often over 80%. The price erosion directly impacts profit margins but enables broader accessibility, which may support volume-driven revenue strategies in emerging markets.

Market Expansion and Strategic Alliances

Emerging markets such as China and India, with their expanding healthcare infrastructure and rising hypertension prevalence, represent key growth opportunities. Partnering with local distributors or engaging in licensing agreements can drive volume sales. Additionally, some manufacturers explore fixed-dose combinations (FDCs) enhancing adherence and competitive differentiation.

Pipeline and Future Developments

While the original irbesartan molecule is now available generically, ongoing efforts focus on novel indications, combination therapies, or modified formulations to extend product life cycles. Nonetheless, the current primary revenue driver remains generic sales.

Market Challenges and Opportunities

Challenges

• Patent Expiry and Generics: The dominant challenge stems from patent expiration, leading to commoditization and price competition.
• Regulatory Hurdles: Variations in approval processes and drug registration requirements across countries hinder swift market expansion.
• Market Saturation: Mature markets exhibit limited growth potential, necessitating diversification.

Opportunities

• Biosimilars and Innovative Formulations: Investing in new formulations or biosimilar derivatives could recast AVAPRO’s market positioning.
• Expanding Indications: Emerging evidence supports broader use in conditions such as heart failure or stroke prevention, potentially creating new revenue streams.
• Digital and Precision Medicine Initiatives: Leveraging digital adherence tools or personalized dosing strategies can differentiate future offerings.

Conclusion: Financial Outlook

The outlook for AVAPRO's revenue primarily hinges on the management of patent expiration impacts and strategic adaptation to generic competition. While traditional branded sales have declined markedly, revenues generated via generics, licensing, and newer indications underpin a stable but evolving financial trajectory. Stakeholders should focus on innovation, geographic expansion, and value-added services to sustain long-term profitability.

Key Takeaways

• Patent expiration has significantly shifted AVAPRO’s revenue from brand-name sales to generics, requiring strategic adaptation.
• Market expansion in emerging economies offers substantial growth potential, especially with local partnerships.
• Future financial strength depends on diversification into new indications, formulations, and leveraging digital health trends.
• Competitive dynamics demand ongoing innovation to mitigate intense price competition from alternative ARBs.
• Lifecycle management strategies, including combination therapies and biosimilars, are essential to extend AVAPRO’s market relevance.

FAQs

1. What caused the decline in AVAPRO’s sales post-2017?
   Patent expiration and the entry of generic irbesartan dramatically reduced branded sales, naturally shifting revenues toward generics.

2. Are there new therapeutic indications for AVAPRO beyond hypertension and diabetic nephropathy?
   Current research explores potential uses in heart failure and stroke prevention, but these are not yet approved indications.

3. How can pharmaceutical companies sustain profits for drugs like AVAPRO post-patent expiration?
   Strategies include developing improved formulations, exploring new indications, expanding geographies, and engaging in licensing deals.

4. What are the primary health policy drivers influencing AVAPRO’s market?
   Increased emphasis on hypertension control, guidelines favoring ARBs over ACE inhibitors, and access initiatives in emerging markets bolster demand.

5. What is the future outlook for branded AVAPRO in a landscape dominated by generics?
   The future is likely constrained unless innovative differentiation efforts emerge. Focus on niche markets or combination therapies may offer viable paths.

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Sources:
[1] IQVIA. (2022). Global Pharmaceutical Market Data.