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, Prinston Inc, Sandoz, Sciegen Pharms Inc, Teva Pharms, Unichem, Upsher Smith Labs, Watson Labs Inc, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for IRBESARTAN

US Patents:	0
Tradenames:	2
Applicants:	23
NDAs:	23
Drug Master File Entries:	38
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	125
Patent Applications:	6,891
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
Iain Bressendorff	Phase 2
University of Edinburgh	Phase 2
Handok Inc.	Phase 1

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
Apotex Inc	IRBESARTAN	irbesartan	TABLET;ORAL	200832-003	Oct 15, 2012		DISCN	No	No
Watson Labs Inc	IRBESARTAN	irbesartan	TABLET;ORAL	090720-002	Oct 12, 2012		DISCN	No	No
Zydus Pharms Usa Inc	IRBESARTAN	irbesartan	TABLET;ORAL	079213-003	Sep 27, 2012	AB	RX	No	No
Apotex Inc	IRBESARTAN	irbesartan	TABLET;ORAL	200832-002	Oct 15, 2012		DISCN	No	No
Ajanta Pharma Ltd	IRBESARTAN	irbesartan	TABLET;ORAL	203685-001	Dec 10, 2015		DISCN	No	No
Chartwell Molecular	IRBESARTAN	irbesartan	TABLET;ORAL	077205-003	Nov 14, 2012	AB	RX	No	No
Apotex Inc	IRBESARTAN	irbesartan	TABLET;ORAL	200832-001	Oct 15, 2012		DISCN	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
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-003	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-001	Sep 30, 1997

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/000142 Treatment 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/000141 Treatment 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/000785 Treatment 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/001093 Treatment 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/000962 Treatment 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/002510 Sabervel 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/000786 Treatment 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

IRBESARTAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Irbesartan

Introduction

Irbesartan, an angiotensin II receptor blocker (ARB), is a crucial medication in the management of hypertension and diabetic nephropathy. The market for irbesartan tablets is driven by several key factors, including the rising prevalence of hypertension, an increasing geriatric population, and growing awareness of blood pressure control.

Market Size and Forecast

The global irbesartan tablets market was valued at USD 3.10 billion in 2023 and is projected to reach USD 3.85 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 2.45% from 2024 to 2030[3].

Key Drivers

Increasing Prevalence of Hypertension

Hypertension affects an estimated 26% of the world's population, and this prevalence is expected to rise to 29% by 2025, particularly in economically developing countries. This increasing burden of hypertension drives the demand for irbesartan tablets[3].

Rising Geriatric Population

The aging population is more susceptible to hypertension, making irbesartan a vital therapeutic option. The growing geriatric population is a significant driver of the market[1].

Lifestyle Changes and Urbanization

Sedentary lifestyles, unhealthy dietary habits, and urbanization contribute to the rising prevalence of hypertension, creating a substantial market opportunity for irbesartan tablets[1].

Market Segmentation

By Product Type

The market is segmented into 75 mg, 150 mg, and 300 mg tablets. The 150 mg dose is often the recommended starting and maintenance dose, as it is more effective at controlling blood pressure for 24 hours compared to the 75 mg dose[3].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to grow significantly during the forecast period[3].

By Geography

The global irbesartan tablets market is classified into North America, Europe, Asia-Pacific, and the rest of the world. North America currently holds the largest market share due to a high prevalence of hypertension and well-established healthcare infrastructure. However, the Asia-Pacific region is expected to witness significant growth due to the increasing geriatric population and improving access to healthcare[1].

Competitive Landscape

The global irbesartan tablets market is highly competitive, with key players including Pfizer Inc., AstraZeneca PLC, Sanofi S.A., Novartis International AG, and Teva Pharmaceutical Industries Ltd. Other notable players include Apotex, Jiangsu Hengrui Medicine, Taj Pharmaceuticals, Zhuhai Rundu Pharmaceutica, and Verdant Life Sciences[1][3].

Cost-Effectiveness and Patient Outcomes

Studies have shown that early initiation of irbesartan treatment in hypertensive patients with type 2 diabetes and microalbuminuria can be cost-effective and improve life expectancy. Early irbesartan treatment was projected to save significant costs and add undiscounted life-years compared to late treatment or standard care[2].

SWOT Analysis

Strengths

Irbesartan tablets are a proven and widely prescribed medication for hypertension management, offering efficacy in blood pressure control and reducing the risk of cardiovascular diseases[1].

Weaknesses

Potential side effects and adverse reactions can impact patient compliance. The presence of generic versions in the market may also affect market share and pricing[1].

Opportunities

The growing emphasis on preventive healthcare, emerging markets, and technological advancements present opportunities for market expansion and the development of innovative formulations[1].

Threats

Competition from alternative antihypertensive medications and the stringent regulatory landscape pose threats to market growth and profitability[1].

Market Trends

Personalized Treatment Approaches

The trend towards personalized medicine and tailored treatment approaches provides opportunities for customized irbesartan dosing regimens and combination therapies[1].

Focus on Patient-Centric Care

Healthcare providers are increasingly emphasizing patient-centric care, which includes individualized hypertension management plans incorporating irbesartan tablets[1].

Covid-19 Impact

The Covid-19 pandemic has had mixed impacts on the irbesartan tablets market. While it raised awareness about the importance of managing underlying conditions like hypertension, disruptions in healthcare services and supply chains affected market dynamics and patient access to medications[1].

Financial Trajectory

The market is expected to witness steady growth driven by the increasing prevalence of hypertension and growing awareness of blood pressure management. Technological advancements, personalized treatment approaches, and collaborations are expected to shape the future of the market. However, challenges such as generic competition and stringent regulatory requirements need to be addressed for sustained market growth[1].

Key Industry Developments

The market is driven by research and development, market penetration strategies, and collaborations among industry participants. These efforts contribute to improved patient outcomes and address the global burden of hypertension effectively[1].

Conclusion

The global irbesartan tablets market is driven by the increasing prevalence of hypertension, the rising geriatric population, and lifestyle changes. The market offers significant revenue opportunities for pharmaceutical manufacturers and healthcare providers. By focusing on research, market penetration, and patient-centric care, industry participants can contribute to improved patient outcomes and effectively address the global burden of hypertension.

Key Takeaways

• The global irbesartan tablets market is projected to grow at a CAGR of 2.45% from 2024 to 2030.
• The increasing prevalence of hypertension and the rising geriatric population are key drivers of the market.
• Personalized treatment approaches and patient-centric care are emerging trends.
• The market is highly competitive with several key players.
• Early initiation of irbesartan treatment can be cost-effective and improve patient outcomes.

FAQs

Q: What is the primary use of irbesartan tablets? A: Irbesartan tablets are primarily used to treat high blood pressure (hypertension) and to manage high blood pressure with diabetic nephropathy[5].

Q: Which regions are expected to drive the growth of the irbesartan tablets market? A: North America currently holds the largest market share, but the Asia-Pacific region is expected to witness significant growth due to the increasing geriatric population and improving access to healthcare[1].

Q: What are the potential side effects of irbesartan? A: Potential side effects include acid or sour stomach, belching, body aches, bone pain, congestion, cough, and others. It is important to consult a healthcare professional if any side effects are bothersome or persistent[5].

Q: How does irbesartan work? A: Irbesartan works by blocking a substance in the body that causes blood vessels to tighten, thereby relaxing the blood vessels, lowering blood pressure, and increasing the supply of blood and oxygen to the heart[5].

Q: What is the cost-effectiveness of early irbesartan treatment? A: Early irbesartan treatment in hypertensive patients with type 2 diabetes and microalbuminuria can save significant costs and add undiscounted life-years compared to late treatment or standard care[2].