AVALIDE Drug Patent Profile

Which patents cover Avalide, and what generic alternatives are available?

Avalide is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in AVALIDE is hydrochlorothiazide; irbesartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; irbesartan profile page.

Summary for AVALIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	3
Patent Applications:	78
Drug Prices:	Drug price information for AVALIDE
What excipients (inactive ingredients) are in AVALIDE?	AVALIDE excipients list
DailyMed Link:	AVALIDE at DailyMed

See drug prices for AVALIDE

Recent Clinical Trials for AVALIDE

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

Sponsor	Phase
Bayer	Phase 3
Roxane Laboratories	N/A

See all AVALIDE clinical trials

Pharmacology for AVALIDE

Drug Class	Angiotensin 2 Receptor Blocker Thiazide Diuretic
Mechanism of Action	Angiotensin 2 Receptor Antagonists
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for AVALIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVALIDE	Tablets	hydrochlorothiazide; irbesartan	300 mg/25 mg	020758	1	2006-06-06
AVALIDE	Tablets	hydrochlorothiazide; irbesartan	150 mg/12.5 mg and 300 mg/12.5 mg	020758	1	2004-11-10

US Patents and Regulatory Information for AVALIDE

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	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997		DISCN	Yes	No
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005		DISCN	Yes	No
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	AB	RX	Yes	Yes

Expired US Patents for AVALIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005

EU/EMA Drug Approvals for AVALIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
sanofi-aventis groupe	Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)	irbesartan, hydrochlorothiazide	EMEA/H/C/000783 Treatment of essential hypertension. This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	2007-01-18
Sanofi Winthrop Industrie	Karvezide	irbesartan, hydrochlorothiazide	EMEA/H/C/000221 Treatment of essential hypertension.This fixed-dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	1998-10-16
Sanofi Winthrop Industrie	CoAprovel	irbesartan, hydrochlorothiazide	EMEA/H/C/000222 Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.	Authorised	no	no	no	1998-10-14

International Patents for AVALIDE

See the table below for patents covering AVALIDE 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

Supplementary Protection Certificates for AVALIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0565634	06C0030	France		PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215

AVALIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Avapro (Irbesartan) and Avalide (Irbesartan/Hydrochlorothiazide)

Introduction

Avapro (Irbesartan) and Avalide (Irbesartan/Hydrochlorothiazide) are medications used to treat high blood pressure and kidney problems associated with type 2 diabetes. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Size and Forecast

The Irbesartan Tablets Market, which includes Avapro, was valued at $3.10 billion in 2023 and is projected to reach $3.85 billion by 2030, growing at a CAGR of 2.45% from 2024 to 2030[1].

Drivers of Market Growth

Increasing Prevalence of Hypertension

The rising prevalence of high blood pressure is a significant driver of the Irbesartan Tablets Market. Hypertension affects an estimated 26% of the world’s population, and this number is expected to rise to 29% by 2025, particularly in economically developing countries[1].

Treatment of Kidney Problems

Irbesartan is also used to treat kidney problems caused by type 2 diabetes, further fueling market growth. The dual use of Irbesartan in managing both hypertension and diabetic nephropathy enhances its market demand[1].

Key Players

The market for Irbesartan and Avalide is dominated by several key players:

• Apotex
• Sanofi
• Teva
• Jiangsu Hengrui Medicine
• Taj Pharmaceuticals
• Zhuhai Rundu Pharmaceutica
• Verdant Life Sciences

These companies play a crucial role in the production, distribution, and marketing of these medications[1].

Regional Market Analysis

The market is segmented into several regions, including Europe, Asia Pacific, and the Rest of the World. Each region has its own market dynamics and growth prospects:

• Europe: Countries like Germany, the U.K., and France are significant markets due to their large patient populations and well-established healthcare systems[1].
• Asia Pacific: Countries such as China, Japan, and India are experiencing rapid growth due to increasing healthcare spending and a rising prevalence of hypertension and diabetes[1].
• Rest of the World: This includes Latin America and the Middle East and Africa, which are also seeing growth driven by improving healthcare infrastructure and increasing awareness of hypertension and diabetes[1].

Financial Performance of Generic Versions

Generic versions of Avapro and Avalide have been launched by several companies, including Mylan. For instance, Mylan's generic Irbesartan Tablets had U.S. sales of approximately $400.7 million for the 12 months ending June 30, 2012[4].

Competitive Landscape

The competitive landscape of the Irbesartan and Avalide market is highly competitive, with multiple players vying for market share. Key development strategies include product innovation, strategic partnerships, and aggressive marketing. Companies also focus on product benchmarking and SWOT analysis to stay ahead in the market[1].

Financial Trajectory

Revenue and Growth

The revenue from Irbesartan and Avalide is expected to grow steadily over the forecast period. The increasing demand for these medications, driven by the rising prevalence of hypertension and diabetic nephropathy, contributes to this growth[1].

Cost and Pricing

The cost of production and pricing strategies are critical factors in the financial trajectory of these drugs. Generic versions often offer a more affordable alternative, which can impact the pricing dynamics of the market[4].

Challenges and Restraints

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can significantly impact the market. For example, strict FDA approvals and post-marketing surveillance can affect the launch and sales of these medications[4].

Side Effects and Precautions

Irbesartan and Avalide have several side effects and precautions, including excessive reductions in blood pressure, decreased renal function, and potassium and electrolyte abnormalities. These factors can influence patient compliance and overall market growth[4].

Market Opportunities

Expanding Patient Base

The increasing prevalence of hypertension and diabetes presents a significant opportunity for the Irbesartan and Avalide market. Expanding into new regions and targeting underserved populations can further drive market growth[1].

Product Innovations

Continuous innovation in drug delivery systems and formulations can enhance patient compliance and improve treatment outcomes, thereby expanding the market[1].

Conclusion

The market for Avapro (Irbesartan) and Avalide (Irbesartan/Hydrochlorothiazide) is driven by the increasing prevalence of hypertension and diabetic nephropathy. Key players are focusing on product innovation, strategic partnerships, and aggressive marketing to capture market share. Despite challenges such as regulatory environments and side effects, the market is expected to grow steadily over the forecast period.

Key Takeaways

• The Irbesartan Tablets Market is projected to reach $3.85 billion by 2030.
• Increasing prevalence of hypertension and diabetic nephropathy are key drivers.
• Key players include Apotex, Sanofi, Teva, and others.
• Regional markets such as Europe, Asia Pacific, and the Rest of the World offer significant growth opportunities.
• Generic versions play a crucial role in market dynamics.
• Regulatory environments and side effects are significant challenges.

FAQs

Q: What is the projected market size for Irbesartan Tablets by 2030?

A: The Irbesartan Tablets Market is projected to reach $3.85 billion by 2030[1].

Q: What are the primary drivers of the Irbesartan Tablets Market?

A: The increasing prevalence of high blood pressure and the use of Irbesartan to treat kidney problems caused by type 2 diabetes are primary drivers[1].

Q: Who are the major players in the Irbesartan Tablets Market?

A: Major players include Apotex, Sanofi, Teva, Jiangsu Hengrui Medicine, Taj Pharmaceuticals, Zhuhai Rundu Pharmaceutica, and Verdant Life Sciences[1].

Q: What are the potential side effects of Irbesartan and Avalide?

A: Potential side effects include excessive reductions in blood pressure, decreased renal function, and potassium and electrolyte abnormalities[4].

Q: How does the generic version impact the market for Avapro and Avalide?

A: Generic versions offer a more affordable alternative, which can impact pricing dynamics and market share of the branded versions[4].