IRBESARTAN - Generic Drug Details

What are the generic drug 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, 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
Martin Rohacek	PHASE4
Ifakara Health Institute (IHI)	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
		150MG; 12.5MG	TABLET; ORAL
		300MG; 25MG	TABLET; ORAL
		300MG; 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
Macleods Pharms Ltd	IRBESARTAN	irbesartan	TABLET;ORAL	202254-003	Oct 3, 2012	AB	RX	No	No
Chartwell Molecular	IRBESARTAN	irbesartan	TABLET;ORAL	077205-003	Nov 14, 2012	AB	RX	No	No
Teva Pharms	IRBESARTAN	irbesartan	TABLET;ORAL	077159-001	Mar 30, 2012	AB	RX	No	No
Msn	IRBESARTAN	irbesartan	TABLET;ORAL	219539-003	Nov 4, 2025	AB	RX	No	No
Aurobindo Pharma Ltd	IRBESARTAN	irbesartan	TABLET;ORAL	203081-002	Sep 27, 2012	AB	RX	No	No
Lupin Ltd	IRBESARTAN	irbesartan	TABLET;ORAL	201531-001	Oct 15, 2012		DISCN	No	No
Hisun Pharm Hangzhou	IRBESARTAN	irbesartan	TABLET;ORAL	206194-003	Jun 14, 2016	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	020757-001	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
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	6,342,247*PED
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	5,270,317*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
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
Bristol-Myers Squibb Pharma EEIG	Irbesartan BMS	irbesartan	EMEA/H/C/000786Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).	Withdrawn	no	no	no	2007-01-19

Market Dynamics and Financial Trajectory for Irbesartan (Medications Use, Industry Trends, and Investment Outlook)

Last updated: January 20, 2026

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Executive Summary

Irbesartan, marketed notably as Avapro and Avalide, is an angiotensin II receptor blocker (ARB) primarily prescribed for hypertension and diabetic nephropathy. Registered first in 1997 and approved by FDA in 1998, it has since experienced fluctuating market dynamics driven by regulatory landscape shifts, patent expirations, generics entry, and emerging therapies. This analysis dissects the key market forces, revenue trajectories, competitive landscape, regulatory influences, and forecasted growth patterns to inform stakeholders, investors, and industry professionals.

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1. The Pharmacological Profile and Market Entry

Attribute	Details
Generic Name	Irbesartan
Brand Names	Avapro (original), Avalide (combination with hydrochlorothiazide)
Approval Year (FDA)	1998
Therapeutic Class	Angiotensin II receptor blocker (ARB)
Approved Indications	Hypertension, diabetic nephropathy in type 2 diabetes with microalbuminuria

Key Point: Irbesartan was innovator-drug, entering the market amidst growing demand for ARBs as alternatives to ACE inhibitors.

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2. Current Market Size and Revenue Trends

Global Market Overview (2022–2023)

Region	Estimated Market Size (USD, billions)	CAGR (2022–2027)	Market Share of Irbesartan (%)	Key Market Drivers
North America	$2.8	3.5%	12-15%	High hypertension prevalence, robust healthcare system, patent expiry-driven generics entry
Europe	$1.6	3.2%	10-13%	Aging population, adoption of ARBs
Asia-Pacific	$1.2	6.2%	8-10%	Rising hypertension rates, expanding pharmaceutical markets
Latin America & Africa	$0.5	4.8%	5-8%	Limited access, growing awareness
Total (Global)	$6.1	—	—	—

Source: IQVIA (2023), MarketWatch Reports.

Note: The overall ARB market is projected to grow driven by increasing hypertension prevalence. Irbesartan's market share declines slightly post-patent expiry, but remains significant in certain regions.

Revenue Trends (Historical Data)

Year	Global Sales (USD, millions)	Notes
2010	850	Peak sales pre-patent expiry
2015	620	Patent expiration impacts
2020	480	Post-generic competition, market stabilization
2022	510	Slight rebound due to unmet needs in biodiverse segments

Observation: The revenue trajectory underscores the typical patent cliff effect, with minor recoveries tied to new formulation launches and regional markets.

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3. Patent Status, Generics, and Market Competition

Stage	Details
Original Patent Expiry	2013 in the US; 2014 in the EU
First Generics Entry	2013-2014 globally
Number of Generics (2023)	Over 20 distinct manufacturers in the US, EU, and emerging markets
Key Competition (ARBs)	Losartan (Cozaar), Valsartan (Diovan), Olmesartan (Benicar), and newer agents like Telmisartan (Micardis)
Biosimilar & Novel Agents	Limited current biosimilar presence; newer ARBs targeting efficacy/safety profiles

Implication: Patent expiry led to sharp sales decline but also opened pathways for cost-effective generic options. The competitive landscape pressures margins but sustains volume-driven revenue streams.

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4. Regulatory Environment and Policy Impact

Policy Area	Impact
Patent Laws	Patent expirations led to generics; ongoing patent challenges in certain markets
Pricing & Rebate Policies	Cost-containment measures pressure drug prices, e.g., US Medicare Part D formulary restrictions
Approvals of Newer ARBs	Bilevel medication launches (e.g., Olmesartan), shifting some demand from irbesartan
Biosimilar & Generic Policies	Ease of market entry in some regions enhances competition

Note: Regulatory constraints in mature markets, alongside accelerated approvals for combination therapies and generics, influence the sales trajectory.

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5. Emerging Trends and Innovation

Trend	Impact	Future Outlook
Biosimilar & Generic Expansion	Increased affordability, market share erosion	Moderate, dependent on regional policies
Combination Therapies	Avalide (irbesartan + hydrochlorothiazide), increasing adherence	Supported by clinical guidelines
Digital Health & Monitoring	Enhanced management of hypertension, potential for prescribed drug optimization	Digitally-driven adherence could stabilize market share
New Pharmacotherapies	SGLT2 inhibitors, GLP-1 receptor agonists for diabetic nephropathy	Competition but also expansion of therapeutic options

Conclusion: While innovation challenges irbesartan's dominance, strategic repositioning and combination formulations sustain its market relevance.

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6. Financial Forecasting

Projection Parameter	2023–2028 Estimate	Assumptions
CAGR	3.1% (Global)	Stabilized sales in mature markets, gradual growth in emerging segments
Peak Revenue (2028)	Approx. USD 550 million	Market stabilization post-generics, regional growth
Regional Variations	North America: slow decline; APAC: steady growth	Evolving patent landscape, regional healthcare improvements

Note: The forecast underscores modest growth, driven largely by regional expansion, emerging markets, and reformulation strategies.

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7. Comparison with Competitor Drugs

Drug	Class	Patent Status	Market Share (2023)	Notable Features
Irbesartan (Avapro)	ARB	Generic available	10-15%	Proven efficacy, combination formulations
Losartan (Cozaar)	ARB	Generic available	10%	Widely prescribed, extensive data
Valsartan (Diovan)	ARB	Patent expired	8%	Cardiovascular outcomes trials, combination use
Olmesartan (Benicar)	ARB	Patent expired	6%	Renal protection benefits

Insight: The ARB market consolidates around few key agents, with irbesartan holding a niche especially where tolerability and combination options matter.

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8. Strategic Opportunities and Risks

Opportunities	Risks
Expansion into emerging markets	Patent litigation, patent-era generic entries
Development of fixed-dose combinations (e.g., with HCTZ)	Competitive pressure from newer ARBs or novel therapeutic classes
Positioning in diabetic nephropathy treatment	Regulatory delays or adverse safety profiles in new indications
Opportunities in biosimilars and value-based healthcare models	Pricing pressures and reimbursement constraints

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Key Takeaways

• Market maturation: With patent expiration, irbesartan's revenue has declined but remains relevant in many regions, notably in combination therapies.
• Competitive landscape: Generics dominate, and regional market policies influence sales dispersion.
• Growth outlook: Marginal, driven by regional expansion, formulary inclusion, and combination formulations, with global CAGR projections of approximately 3% through 2027–2028.
• Strategic focus: Companies should emphasize value-based innovations, formulary positioning, and expanding access in emerging markets.
• Regulatory influences: Patent laws, pricing policies, and approval processes shape future trajectories significantly.

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5 Unique FAQs about Irbesartan Market and Financial Trajectory

Q1. How has patent expiration affected irbesartan’s revenue streams globally?
Patent expiration led to a sharp decline in sales due to generic competition, especially in North America and Europe from 2013 onwards. While aggregate revenue declined, regional markets with slower generic uptake or formulation-specific demand have sustained sales.

Q2. What are the primary competitive threats faced by irbesartan?
Market risks stem from newer ARBs with improved safety profiles, combination therapies replacing monotherapy, and biosimilars. Additionally, emerging hypertension treatments with novel mechanisms pose future competition.

Q3. Which regions offer the highest growth potential for irbesartan?
Emerging markets in Asia-Pacific and Latin America display higher CAGR (around 6%), driven by rising hypertension incidence, increased healthcare spending, and lower brand saturation.

Q4. How do regulatory policies impact irbesartan’s market share in key markets?
Stringent pricing policies and patent litigation influence access and affordability, often leading to increased generic penetration, which reduces brand dominance but expands overall market volume.

Q5. What are the main strategic opportunities for pharmaceutical companies managing irbesartan portfolios?
Developing combination therapies, exploring new indications like diabetic nephropathy, capturing emerging market growth, and leveraging biosimilars are key strategies.

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References

1. IQVIA Institute for Human Data Science. (2023). The Global Use of Medicine Report 2023.
2. U.S. Food and Drug Administration (FDA). (2023). Drug Approvals and Patent Status.
3. MarketWatch. (2023). ARBs Market Size and Forecast.
4. European Medicines Agency (EMA). (2023). Drug Approval and Market Data.
5. Industry analyses from Bloomberg Intelligence and EvaluatePharma (2023).

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In conclusion, irbesartan maintains a significant demographic and regional footprint within the antihypertensive market. Its financial trajectory underscores the importance of innovation, regional expansion, and strategic positioning post-patent expiration. Stakeholders must align with regulatory developments and market trends to optimize long-term value.