Hydrochlorothiazide; irbesartan - Generic Drug Details

What are the generic sources for hydrochlorothiazide; irbesartan and what is the scope of freedom to operate?

Hydrochlorothiazide; irbesartan is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, 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 sixteen NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for hydrochlorothiazide; irbesartan

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	16
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	15
Patent Applications:	166
DailyMed Link:	hydrochlorothiazide; irbesartan at DailyMed

Recent Clinical Trials for hydrochlorothiazide; irbesartan

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

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

See all hydrochlorothiazide; irbesartan clinical trials

Generic filers with tentative approvals for HYDROCHLOROTHIAZIDE; IRBESARTAN

Applicant	Application No.	Strength	Dosage Form
		12.5MG;300MG	TABLET;ORAL
		12.5MG;150MG	TABLET;ORAL
		25MG;300MG	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 hydrochlorothiazide; irbesartan

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

Anatomical Therapeutic Chemical (ATC) Classes for hydrochlorothiazide; irbesartan

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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 HYDROCHLOROTHIAZIDE; IRBESARTAN

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 hydrochlorothiazide; irbesartan

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	077369-001	Mar 30, 2012	AB	RX	No	No
Atlas Pharms Llc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203036-003	Jan 15, 2016		DISCN	No	No
Prinston Inc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203072-002	May 9, 2014	AB	RX	No	No
Norvium Bioscience	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	077969-003	Jul 20, 2016		DISCN	No	No
Atlas Pharms Llc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	203036-002	Jan 15, 2016		DISCN	No	No
Apotex Inc	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	201505-002	Oct 15, 2012		DISCN	No	No
Alembic	IRBESARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	091370-001	Oct 15, 2012	AB	RX	No	No

Expired US Patents for hydrochlorothiazide; irbesartan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	5,994,348*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-004	Mar 15, 2005	5,994,348*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-003	Aug 31, 1998	5,270,317*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	5,994,348*PED
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-001	Sep 30, 1997	5,994,348*PED

EU/EMA Drug Approvals for hydrochlorothiazide; irbesartan

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
Bristol-Myers Squibb Pharma EEIG	Irbesartan Hydrochlorothiazide BMS	irbesartan, hydrochlorothiazide	EMEA/H/C/000784 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 (see section 5.1).	Withdrawn	no	no	no	2007-01-19

Hydrochlorothiazide; irbesartan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Irbesartan and Hydrochlorothiazide

Market Overview

The market for irbesartan and hydrochlorothiazide, a combination used to treat hypertension and related conditions, is driven by several key factors. Here’s a comprehensive look at the market dynamics and financial trajectory of this drug combination.

Market Size and Forecast

The irbesartan tablets market, which includes combinations with hydrochlorothiazide, 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 global prevalence of hypertension is a significant driver of the market. Hypertension affects an estimated 1.28 billion people aged 30 to 79 globally, with the majority living in low- and middle-income countries. This high prevalence, expected to rise to 29% by 2025, fuels the demand for antihypertensive medications like irbesartan and hydrochlorothiazide[1].

Treatment of Kidney Problems

Irbesartan is also used to treat kidney problems caused by type 2 diabetes, further expanding its market. Diabetic patients and those with diabetic nephropathy are more likely to be prescribed the irbesartan/HCTZ combination, contributing to market growth[4].

Segmentation Analysis

Product Type

The market is segmented into different product types based on the dosage of irbesartan:

• 75 mg Tablets
• 150 mg Tablets
• 300 mg Tablets

The 150 mg dosage is often more effective than the 75 mg at controlling blood pressure for 24 hours, making it a preferred choice[1].

Distribution Channel

The market is segmented by distribution channels:

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

Hospital Pharmacies are expected to grow significantly during the forecasted years[1].

Geography

The global market is classified into:

• North America
• Europe
• Asia Pacific
• Rest of the world

Each region has its own growth trajectory, with varying demand and market dynamics[1].

Competitive Landscape

Key Players

Major players in the irbesartan tablets market include:

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

These companies are analyzed based on their financial performance, product outlook, and key developments. The competitive landscape also includes market share and ranking analysis[1].

Cost-Effectiveness and Clinical Efficacy

Cost-Effectiveness

Studies have shown that the combination of irbesartan and hydrochlorothiazide is cost-effective compared to other antihypertensive treatments. For example, in a Swedish health-care setting, irbesartan 150 mg/HCTZ 12.5 mg was found to be a dominant strategy, offering better health effects at lower costs compared to losartan and valsartan combinations[2].

Clinical Efficacy

The irbesartan/HCTZ combination has been associated with significant reductions in both systolic and diastolic blood pressure, particularly in diabetic patients. This combination is more effective than valsartan/HCTZ in reducing blood pressure in such patients[4].

Mechanism of Action

Irbesartan

Irbesartan belongs to the class of angiotensin-II receptor antagonists. It blocks angiotensin-II, which causes blood vessels to narrow, thereby widening the blood vessels and making it easier for the heart to pump blood, thus lowering blood pressure[3].

Hydrochlorothiazide

Hydrochlorothiazide is a diuretic that increases urine volume and helps lower blood pressure, especially when combined with other blood pressure-reducing medicines[3].

Adverse Effects and Safety

While generally well-tolerated, the combination of irbesartan and hydrochlorothiazide can have adverse effects such as hypokalemia (low potassium levels), pancreatitis, and other dose-dependent and dose-independent phenomena. However, these adverse events are relatively rare and mild, with only 3.6% of patients discontinuing therapy due to clinical adverse events[5].

Market Restraints

Adverse Effects

Adverse effects such as chills, cold sweats, confusion, dizziness, and faintness can restrain market expansion. Additionally, FDA voluntary recalls due to suspected cancer-causing chemicals and contamination have also impacted the market[1].

Regional Market Analysis

North America and Europe

These regions have a well-established market for irbesartan and hydrochlorothiazide, driven by high healthcare standards and awareness of hypertension treatment.

Asia Pacific

This region is expected to see significant growth due to increasing healthcare expenditure and a rising prevalence of hypertension in economically developing countries[1].

Key Takeaways

• The irbesartan tablets market, including combinations with hydrochlorothiazide, is projected to grow at a CAGR of 2.45% from 2024 to 2030.
• The increasing prevalence of hypertension and the use of irbesartan in treating kidney problems are key drivers.
• The market is segmented by product type, distribution channel, and geography.
• Major players include Apotex, Sanofi, and Teva, among others.
• The combination of irbesartan and hydrochlorothiazide is cost-effective and clinically efficacious.
• Adverse effects and regulatory issues are market restraints.

FAQs

1. What is the primary use of irbesartan and hydrochlorothiazide?

Irbesartan and hydrochlorothiazide are primarily used to treat high blood pressure (hypertension) and kidney problems caused by type 2 diabetes.

2. How does the combination of irbesartan and hydrochlorothiazide work?

Irbesartan blocks angiotensin-II, widening blood vessels, while hydrochlorothiazide acts as a diuretic, increasing urine volume and helping to lower blood pressure.

3. What are the common dosages of irbesartan tablets?

Common dosages include 75 mg, 150 mg, and 300 mg tablets, with 150 mg once daily being a usual recommended dose.

4. Which distribution channel is expected to grow significantly?

Hospital Pharmacies are expected to grow significantly during the forecasted years.

5. What are some potential adverse effects of irbesartan and hydrochlorothiazide?

Potential adverse effects include hypokalemia, pancreatitis, chills, cold sweats, confusion, dizziness, and faintness.

Cited Sources:

1. Verified Market Research: In-Depth Industry Outlook: Irbesartan Tablets Market Size & Forecast.
2. PubMed: Cost-effectiveness of irbesartan/hydrochlorothiazide in patients with hypertension.
3. NPS MedicineWise: APO-Irbesartan HCTZ - NPS MedicineWise.
4. Karger: Comparative Efficacy of Irbesartan/ Hydrochlorothiazide and Valsartan/Hydrochlorothiazide.
5. Drugs.com: Irbesartan and Hydrochlorothiazide: Package Insert / Prescribing Info.