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-two 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:	2
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 North Carolina	Phase 1/Phase 2
Duke University	Phase 1/Phase 2
Clinical Research Management, Inc.	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
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 AVAPRO

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

International Patents for AVAPRO

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

Country	Patent Number	Title	Estimated Expiration
Hungary	9601564
Canada	2177772	COMPOSITIONS PHARMACEUTIQUES RENFERMANT DE L'IRBESARTAN (PHARMACEUTICAL COMPOSITIONS CONTAINING IRBESARTAN)
Taiwan	201738
Norway	914528
Portugal	1275391
Australia	5476396
Germany	69638348

Supplementary Protection Certificates for AVAPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	98C0028	Belgium		PRODUCT NAME: IRBESARTAN; NATL. REGISTRATION NO/DATE: EU/1/97/046/001 19970827; FIRST REGISTRATION: CH 54250 02 19970815
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
0454511	SPC/GB98/037	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.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0454511	10/1999	Austria		PRODUCT NAME: ''IRBESARTAN'' ZUSAMMEN MIT ''HYDROCHLOROTHIAZID''; REGISTRATION NO/DATE: EU/1/98/086/001 - EU/1/98/086/006 19981015

AVAPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AVAPRO (Irbesartan)

Market Overview

The market for AVAPRO (irbesartan), an angiotensin II receptor antagonist, is driven by several key factors that influence its dynamics and growth.

Increasing Prevalence of Hypertension

The global rise in hypertension and related cardiovascular diseases is a significant driver of the AVAPRO market. As the population ages and lifestyle factors contribute to higher blood pressure, the demand for effective antihypertensive medications like irbesartan increases[1].

Expanding Awareness and Efficacy

The expanding awareness of the importance of blood pressure management and the safety and efficacy of Angiotensin II Receptor Blockers (ARBs) also contribute to market growth. Healthcare providers and patients trust irbesartan for its ability to control hypertension effectively while minimizing side effects[1].

Diabetic Nephropathy Management

Irbesartan is also indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes, hypertension, and proteinuria. This additional indication fuels the demand for the drug, as it reduces the rate of progression of nephropathy and the occurrence of end-stage renal disease[2][3].

Generic Availability

The generic availability of irbesartan offers cost-effective alternatives to patients, further boosting market growth. Generic versions of the drug make it more accessible, increasing its market penetration[1].

Market Segmentation

Drug Class

AVAPRO belongs to the class of Angiotensin II Receptor Blockers (ARBs), which is a significant segment within the antihypertensive drugs market. Other ARBs include olmesartan, valsartan, telmisartan, and candesartan[4].

Geographic Distribution

The global antihypertensive drugs market, including AVAPRO, is segmented geographically into North America, Latin America, Europe, Asia Pacific, and the Rest of the World. Each region has its own market dynamics influenced by local healthcare policies, patient demographics, and economic factors[4].

Financial Trajectory

Project Economics

Setting up a manufacturing plant for AVAPRO involves a detailed analysis of project economics. This includes capital expenditure (CapEx), operating expenditure (OpEx), income projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, Net Present Value (NPV), uncertainty analysis, and sensitivity analysis. These financial metrics are crucial for investors and manufacturers to understand the viability and potential returns of such a project[1].

Cost Analysis

The cost analysis for an AVAPRO manufacturing plant includes the price analysis of feedstocks, industry profit margins, and other expenditures such as machinery, raw materials, packaging, transportation, utilities, and human resources. Understanding these costs is essential for maintaining profitability and competitiveness in the market[1].

Regulatory and Financial Assistance

The setup of an AVAPRO manufacturing plant also involves navigating regulatory procedures and approvals. Financial assistance and certifications required for the plant are critical components that need to be addressed. Compliance with good clinical practices and financial disclosures is mandatory for regulatory approval[1][5].

Clinical Efficacy and Safety

Hypertension Management

AVAPRO has been evaluated for safety in over 4300 patients with hypertension and has shown efficacy in lowering blood pressure and reducing the risk of fatal and non-fatal cardiovascular events such as strokes and myocardial infarction[2].

Diabetic Nephropathy

Clinical trials have demonstrated that AVAPRO reduces the rate of progression of nephropathy in patients with type 2 diabetes, as measured by the occurrence of doubling of serum creatinine or end-stage renal disease. It also significantly reduces proteinuria and the rate of loss of renal function[3].

Safety Profile

While AVAPRO is generally well-tolerated, it can cause adverse reactions such as diarrhea, dyspepsia/heartburn, and fatigue. Patients with impaired renal function or those dependent on the renin-angiotensin system are at particular risk and require periodic monitoring of renal function[2].

Market Size and Growth

Global Antihypertensive Drugs Market

The global antihypertensive drugs market, which includes AVAPRO, is projected to grow significantly from 2024 to 2031. The market size is expected to increase due to the rising prevalence of hypertension and the growing need for effective antihypertensive medications[4].

Market Share Analysis

AVAPRO, as part of the ARBs segment, holds a significant market share within the antihypertensive drugs market. The market share analysis provides insights into the competitive landscape and the position of AVAPRO relative to other ARBs and antihypertensive drugs[4].

Key Takeaways

• Increasing Demand: The global rise in hypertension and related cardiovascular diseases drives the demand for AVAPRO.
• Clinical Efficacy: AVAPRO is effective in managing hypertension and diabetic nephropathy, reducing the risk of cardiovascular events and renal disease progression.
• Financial Viability: Setting up a manufacturing plant for AVAPRO involves detailed project economics, cost analysis, and regulatory compliance.
• Market Growth: The global antihypertensive drugs market, including AVAPRO, is expected to grow significantly from 2024 to 2031.
• Safety Profile: AVAPRO is generally well-tolerated but requires monitoring in patients with impaired renal function.

FAQs

What is AVAPRO used for?

AVAPRO (irbesartan) is used for the treatment of hypertension and diabetic nephropathy in patients with type 2 diabetes and hypertension.

What are the common side effects of AVAPRO?

Common side effects of AVAPRO include diarrhea, dyspepsia/heartburn, and fatigue.

How does AVAPRO work?

AVAPRO works by blocking the action of angiotensin II, a potent vasoconstrictor, thereby reducing blood pressure and the risk of cardiovascular events.

What are the benefits of using AVAPRO for diabetic nephropathy?

AVAPRO reduces the rate of progression of nephropathy, the occurrence of doubling of serum creatinine, and end-stage renal disease in patients with type 2 diabetes.

What are the regulatory requirements for setting up an AVAPRO manufacturing plant?

Setting up an AVAPRO manufacturing plant requires compliance with good clinical practices, financial disclosures, and obtaining necessary certifications and regulatory approvals.

Sources

1. Irbesartan (Avapro) Manufacturing Plant Project Report 2024 - IMARC Group
2. Avapro (Irbesartan): Side Effects, Uses, Dosage, Interactions - RxList
3. AVAPRO - accessdata.fda.gov - FDA
4. Antihypertensive Drugs Market and Forecast 2024-2031 - iHealthcareAnalyst
5. N20-757S039 Irbesartan Clinical - FDA