IRBESARTAN AND HYDROCHLOROTHIAZIDE Drug Patent Profile

When do Irbesartan And Hydrochlorothiazide patents expire, and when can generic versions of Irbesartan And Hydrochlorothiazide launch?

Irbesartan And Hydrochlorothiazide is a drug marketed by Alembic, Apotex Inc, Atlas Pharms Llc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hikma, Hisun Pharm Hangzhou, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sandoz, Teva, Unichem, and Watson Labs Inc. and is included in fifteen NDAs.

The generic ingredient in IRBESARTAN AND HYDROCHLOROTHIAZIDE 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 IRBESARTAN AND HYDROCHLOROTHIAZIDE

US Patents:	0
Applicants:	15
NDAs:	15
Finished Product Suppliers / Packagers:	12
Clinical Trials:	15
What excipients (inactive ingredients) are in IRBESARTAN AND HYDROCHLOROTHIAZIDE?	IRBESARTAN AND HYDROCHLOROTHIAZIDE excipients list
DailyMed Link:	IRBESARTAN AND HYDROCHLOROTHIAZIDE at DailyMed

Recent Clinical Trials for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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

Sponsor	Phase
Damanhour University	N/A
Roxane Laboratories	N/A
Sanofi	Phase 4

See all IRBESARTAN AND HYDROCHLOROTHIAZIDE clinical trials

Pharmacology for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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

US Patents and Regulatory Information for IRBESARTAN AND HYDROCHLOROTHIAZIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077369-003	Mar 30, 2012		DISCN	No	No
Sandoz	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077446-001	Sep 27, 2012	AB	RX	No	No
Unichem	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	207018-001	Sep 19, 2017		DISCN	No	No
Sandoz	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077446-002	Sep 27, 2012	AB	RX	No	No
Alembic	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	091370-001	Oct 15, 2012	AB	RX	No	No

EU/EMA Drug Approvals for IRBESARTAN AND HYDROCHLOROTHIAZIDE

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
Krka, d.d., Novo mesto	Ifirmacombi	irbesartan, hydrochlorothiazide	EMEA/H/C/002302 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	yes	no	no	2011-03-04
Teva B.V.	Irbesartan/Hydrochlorothiazide Teva	irbesartan, hydrochlorothiazide	EMEA/H/C/001112 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	yes	no	no	2009-11-26

IRBESARTAN AND HYDROCHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Irbesartan and Hydrochlorothiazide

Introduction

Irbesartan and hydrochlorothiazide (HCTZ) are commonly used in combination to treat hypertension and other cardiovascular conditions. This combination therapy, often marketed under the brand name Avalide, has seen significant market traction due to its efficacy and the growing prevalence of hypertension globally.

Market Drivers

Increasing Prevalence of Hypertension

The global market for irbesartan and HCTZ is driven largely by the increasing prevalence of hypertension. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[1][3].

Geriatric Population Growth

The rise in the geriatric population is another key factor. Older adults are more likely to develop hypertension and other cardiovascular diseases, thereby increasing the demand for antihypertensive medications like irbesartan and HCTZ[1].

Research and Development

Pharmaceutical companies are continuously involved in research and development activities, leading to the launch of novel and more effective drug combinations. This innovation fuels market growth by offering better treatment options for patients[1].

Healthcare Expenditure

Increasing healthcare expenditure globally also contributes to the market growth. As more resources are allocated to healthcare, the demand for effective treatments for hypertension and related conditions increases[1].

Market Trends

Combination Therapy

The combination of irbesartan, an angiotensin-II receptor blocker (ARB), and HCTZ, a diuretic, has been shown to be highly effective in reducing blood pressure. This combination therapy is safe and produces additive reductions in both systolic and diastolic blood pressure[4][5].

Cost-Effectiveness

Studies have demonstrated that the combination of irbesartan and HCTZ is cost-effective compared to other antihypertensive treatments. For instance, a study in the Swedish healthcare setting found that irbesartan 150 mg/HCTZ 12.5 mg was a dominant strategy in terms of health effects and costs compared to other combinations[2].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to grow significantly during the forecast period due to the increasing number of hospitalizations related to cardiovascular diseases[3].

Financial Trajectory

Market Size and Forecast

The irbesartan tablets market, which includes combinations with HCTZ, was valued at USD 3.10 billion in 2023 and is projected to reach USD 3.85 billion by 2030, growing at a CAGR of 2.45% from 2024 to 2030[3].

Revenue Streams

The revenue for irbesartan and HCTZ combination therapy comes from various segments, including different product types (75 mg, 150 mg, and 300 mg tablets) and distribution channels. The 150 mg tablets are the most commonly prescribed and are often more effective than the 75 mg dose in controlling blood pressure for 24 hours[3].

Key Market Players

Major players in the irbesartan and HCTZ market include Apotex, Sanofi, Teva, Jiangsu Hengrui Medicine, Taj Pharmaceuticals, and Zhuhai Rundu Pharmaceutica. These companies are investing heavily in research and development and are expanding their market presence through strategic partnerships and product launches[3].

Competitive Landscape

Market Share and Ranking

The competitive landscape of the irbesartan and HCTZ market is characterized by intense competition among major pharmaceutical companies. Market share and ranking analyses indicate that companies like Teva and Sanofi hold significant positions due to their extensive product portfolios and strong distribution networks[3].

Development Strategies

Key development strategies include product benchmarking, SWOT analysis, and financial performance evaluations. Companies are also focusing on expanding their geographical presence, particularly in the Asia Pacific region, where the prevalence of hypertension is increasing rapidly[3].

Regional Analysis

Global Market Segmentation

The global irbesartan and HCTZ market is segmented into regions such as North America, Europe, Asia Pacific, and the Rest of the World. The Asia Pacific region is expected to grow significantly due to the increasing prevalence of hypertension and the growing healthcare expenditure in countries like China, Japan, and India[3].

Regional Market Dynamics

In Europe, countries like Germany, the U.K., and France are significant markets due to their well-established healthcare systems and high awareness of hypertension treatment. In the Asia Pacific, the market is driven by the large population and increasing healthcare infrastructure[3].

Challenges and Restraints

Side Effects

One of the major restraints for the irbesartan and HCTZ market is the side effects associated with these medications. While generally well-tolerated, HCTZ can cause dose-related biochemical abnormalities, which irbesartan can help ameliorate to some extent[1][4].

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulatory policies can impact the market. Companies must comply with stringent regulations and obtain necessary approvals, which can be time-consuming and costly[1].

Key Takeaways

• The market for irbesartan and HCTZ is driven by the increasing prevalence of hypertension and the growing geriatric population.
• Combination therapy of irbesartan and HCTZ is highly effective and cost-effective.
• The market is expected to grow at a CAGR of 2.45% from 2024 to 2030.
• Major players are investing in research and development and expanding their market presence.
• The Asia Pacific region is expected to be a significant growth area due to increasing healthcare expenditure and a large population.

FAQs

What is the primary use of irbesartan and hydrochlorothiazide?

Irbesartan and hydrochlorothiazide are primarily used in combination to treat high blood pressure (hypertension) by relaxing blood vessels and helping the kidneys remove more fluid through urine.

How does the combination of irbesartan and HCTZ compare to other antihypertensive treatments?

The combination of irbesartan and HCTZ has been shown to be cost-effective and more effective in reducing blood pressure compared to some other antihypertensive treatments, such as certain angiotensin-II inhibitors combined with HCTZ[2].

What are the common side effects associated with irbesartan and HCTZ?

While generally well-tolerated, HCTZ can cause dose-related biochemical abnormalities. However, irbesartan tends to ameliorate these effects. Common side effects may include dizziness, headache, and changes in kidney function[4][5].

Which regions are expected to drive the growth of the irbesartan and HCTZ market?

The Asia Pacific region is expected to drive significant growth due to the increasing prevalence of hypertension and growing healthcare expenditure in countries like China, Japan, and India[3].

Who are the major players in the irbesartan and HCTZ market?

Major players include Apotex, Sanofi, Teva, Jiangsu Hengrui Medicine, Taj Pharmaceuticals, and Zhuhai Rundu Pharmaceutica. These companies are key in the development, manufacturing, and distribution of irbesartan and HCTZ combination therapy[3].

Sources

1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
2. PubMed: Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension
3. Verified Market Research: In-Depth Industry Outlook: Irbesartan Tablets Market Size & Forecast
4. American Journal of Hypertension: Matrix study of irbesartan with hydrochlorothiazide in mild-to-moderate hypertension
5. Cleveland Clinic: Irbesartan; Hydrochlorothiazide, HCTZ Oral Tablets