Irbesartan - Generic Drug Details

What are the generic sources for irbesartan and what is the scope of freedom to operate?

Irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Chartwell Rx, Hetero Labs Ltd V, Hikma, Hisun Pharm Hangzhou, Ipca Labs Ltd, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Watson Labs Inc, Yiling, and Zydus Pharms Usa Inc, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for irbesartan. Twenty-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for irbesartan

US Patents:	0
Tradenames:	2
Applicants:	24
NDAs:	24
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	131
Patent Applications:	7,369
Drug Prices:	Drug price trends for irbesartan
Drug Sales Revenues:	Drug sales revenues for irbesartan
What excipients (inactive ingredients) are in irbesartan?	irbesartan excipients list
DailyMed Link:	irbesartan at DailyMed

See drug prices for irbesartan

See drug sales revenues for irbesartan

Recent Clinical Trials for irbesartan

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

Sponsor	Phase
Ifakara Health Institute (IHI)	PHASE4
Martin Rohacek	PHASE4
Shanghai Jiao Tong University School of Medicine	NA

See all irbesartan clinical trials

Generic filers with tentative approvals for IRBESARTAN

Applicant	Application No.	Strength	Dosage Form
		300MG; 25MG	TABLET; ORAL
		300MG; 12.5MG	TABLET; ORAL
		150MG; 12.5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for irbesartan

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

Anatomical Therapeutic Chemical (ATC) Classes for irbesartan

C09CA	Angiotensin II receptor blockers (ARBs), plain
C09C	ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs), PLAIN
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

Paragraph IV (Patent) Challenges for IRBESARTAN

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 irbesartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Unichem	IRBESARTAN	irbesartan	TABLET;ORAL	203020-002	Dec 7, 2015	AB	RX	No	No
Teva Pharms	IRBESARTAN	irbesartan	TABLET;ORAL	077159-002	Mar 30, 2012	AB	RX	No	No
Apotex Inc	IRBESARTAN	irbesartan	TABLET;ORAL	200832-001	Oct 15, 2012		DISCN	No	No
Sciegen Pharms Inc	IRBESARTAN	irbesartan	TABLET;ORAL	204774-002	Dec 7, 2015	AB	RX	No	No

Expired US Patents for irbesartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997	5,270,317*PED
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	020757-002	Sep 30, 1997	6,342,247*PED

EU/EMA Drug Approvals for irbesartan

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

Market Dynamics and Financial Trajectory for Irbesartan

Last updated: July 27, 2025

Introduction

Irbesartan, a potent angiotensin II receptor blocker (ARB), is primarily prescribed for hypertension and diabetic nephropathy. Since its approval in the early 2000s, irbesartan has emerged as a prominent candidate within the cardiovascular therapeutic landscape. This article examines the market forces shaping irbesartan’s trajectory, evaluates its current financial performance, and anticipates future trends impacting its commercial viability.

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Regulatory Landscape and Patent Status

Irbesartan was developed by Sanofi and gained FDA approval in 2000, with subsequent approvals in multiple jurisdictions. Its patent protection, initially set to expire around 2012, faced challenges due to patent litigations and generic competition. The expiration of patent exclusivity, subsequent to the expiry of basic patents, has significantly eroded its market share, compelling companies to navigate the complex landscape of biosimilar and generic drug entry.

Current patent environments vary across regions. In the United States, patent challenges led to generic versions entering the market as early as 2012 [1]. The Europe and Asia markets experienced similar timelines. With patent expiration, the price erosion accelerated, affecting revenue streams for original manufacturers.

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Market Dynamics

1. Competitive Landscape and Generic Entry

The main driver of current market dynamics is the proliferation of generic irbesartan. Generics typically capture over 80% of the volume of the original branded product, leading to substantial revenue declines for patent-holders. As of 2023, multiple manufacturers supply generic irbesartan across developed and emerging markets.

2. Pricing Pressures and Price Erosion

Generic competition exerts relentless downward pressure on drug prices. According to IQVIA data, the launch of generic irbesartan in key markets has resulted in price reductions of up to 70% within the first year post-expiry [2]. Price sensitivity among healthcare providers and payers further amplifies this trend.

3. Market Penetration and Prescribing Trends

Despite generic competition, irbesartan retains a valuable niche, particularly among patients with contraindications to ACE inhibitors or other ARBs. Nonetheless, newer ARBs and combination therapies have gained traction, influencing prescribing behaviors. Patent expiration also fosters penetration by competing therapies that offer improved pharmacokinetics or dosing convenience.

4. Regulatory Hurdles and Biosimilar Development

Current developments include biosimilars and new formulations aiming to enhance adherence. Regulatory pathways for biosimilar approval can differ significantly, impacting market entry timelines and competition intensity.

5. Geographic Market Trends

Emerging markets like India and China display significant volumes for irbesartan, driven by cost-effective generics. Conversely, high-income regions favor branded versions longer due to formulary restrictions and physician prescribing habits, although this gap is narrowing with increasing generic acceptance.

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Financial Trajectory and Revenue Outlook

1. Revenue Trends

Since patent expiry, revenues from irbesartan have experienced a sharp decline. Sanofi, the original patent-holder, reported a drop in cardiovascular drug sales post-2012, with generic erosion being a primary factor [3].

2. Market Share Volatility

Generic entries often account for over 80% of sales volume; however, the ASP (average selling price) declines mitigate overall revenue. Companies with diversified portfolios can offset losses stemming from irbesartan’s decline, but standalone sales are markedly affected.

3. Potential for Brand Repositioning

Despite generic competition, branded formulations with superior patient compliance or combination therapies incorporating irbesartan may sustain a niche segment. However, the financial significance remains relatively modest absent patent protections.

4. Mergers, Acquisitions, and Licensing Agreements

Pharmaceutical companies have pursued licensing and acquisition strategies to compensate for declining irbesartan revenues. For instance, Thai and Indian companies leverage local pricing policies to maintain margins through licensing agreements with original or patent-expired patent holders.

5. Impact of Emerging Market Growth

The increasing prevalence of hypertension and diabetic nephropathy, coupled with aging populations in developing economies, ensures a residual demand for irbesartan. Market analysts project that the Asia-Pacific regions will sustain modest growth rates, despite generic competition, fueled by generics substitution policies [4].

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Future Outlook and Strategic Considerations

1. Market Saturation and Decline

The irbesartan market is approaching saturation in established markets. The rapid ascent of alternative ARBs and combination therapies with diuretics or calcium channel blockers may further diminish its relevance.

2. Innovation and Value-Added Formulations

Development of fixed-dose combination (FDC) products and enhanced formulations could offer differentiation but face regulatory and market acceptance hurdles.

3. Biosimilar and Trastuzumab Strategies

While biosimilars are more typical for biologics, biosimilar-like strategies for small molecules, including irbesartan, could influence future competition.

4. Strategic Positioning

Companies should focus on niche markets—special populations, combination products, or generics with value-added attributes—to sustain revenue streams.

5. Policy and Healthcare Dynamics

Changes in healthcare policies, such as price controls and formulary preferences, will continue to influence sales volume and pricing. Payers’ emphasis on cost-effective therapies supports continued decline in irbesartan revenues, especially in cost-sensitive regions.

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Key Takeaways

• Patent expiration has precipitated a dramatic decline in irbesartan revenues, with generic versions dominating market share.
• Price erosion from generics has reduced average selling prices by over 70%, impacting the financial trajectory of original developers.
• Despite market saturation in developed countries, emerging markets retain growth potential driven by increasing disease prevalence and cost-focused healthcare systems.
• Innovation efforts, including combination therapies and biosimilars, are critical for companies seeking to maintain relevance.
• Strategic positioning—emphasizing niche markets, alternative formulations, and licensing—can mitigate revenue decline and extend product lifecycle.

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FAQs

1. What caused the decline in irbesartan’s market share?
   Patent expiration led to widespread generic entry, significantly reducing sales volumes and prices, thus eroding revenue for the original developers.

2. Are there any recent developments in irbesartan formulations?
   Yes. Several companies have developed fixed-dose combination therapies and novel formulations aimed at improving patient adherence and maintaining market relevance.

3. Which regions present the most lucrative opportunities for irbesartan?
   Emerging markets such as India, China, and Southeast Asia continue to offer growth prospects due to high prevalence of hypertension and cost-sensitive healthcare environments.

4. How does the rise of new therapies impact irbesartan's future?
   Newer ARBs or combination therapies with better efficacy, safety, or convenience may further diminish irbesartan’s market share, prompting companies to innovate or reposition their products.

5. What strategic moves can companies adopt to optimize irbesartan’s revenue cycle?
   Firms should explore niche applications, develop value-added formulations, seek licensing opportunities, and adapt to regional regulatory and pricing landscapes.

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References

[1] U.S. Food & Drug Administration. (2012). The GDUFA Regulatory Data.
[2] IQVIA. (2022). Generic Drug Market Trends.
[3] Sanofi Annual Report. (2013).
[4] MarketsandMarkets. (2021). Cardiovascular Drugs Market by Drug Type.

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Conclusion

The market for irbesartan exemplifies the profound influence of patent lifecycle management and generic competition on pharmaceutical financial trajectories. While current revenues are under pressure, geographic diversity and ongoing innovation offer pathways to sustain relevance. Strategic agility, understanding of regional dynamics, and investment in formulation advancements are essential for stakeholders navigating this mature but still significant segment of cardiovascular therapeutics.